SAFETY and EFFICACY of TENELIGLIPTIN OVER OTHER HYPOGLYCEMIC AGENTS in TYPE-2 DIABETES *1 Dr

Total Page:16

File Type:pdf, Size:1020Kb

SAFETY and EFFICACY of TENELIGLIPTIN OVER OTHER HYPOGLYCEMIC AGENTS in TYPE-2 DIABETES *1 Dr IAJPS 2018, 05 (07), 6325-6340 N. Tendu Pranadeep et al ISSN 2349-7750 CODEN [USA]: IAJPBB ISSN: 2349-7750 INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES http://doi.org/10.5281/zenodo.1310608 Available online at: http://www.iajps.com Research Article SAFETY AND EFFICACY OF TENELIGLIPTIN OVER OTHER HYPOGLYCEMIC AGENTS IN TYPE-2 DIABETES *1 Dr. N. Tendu Pranadeep, 1Dr. G. Gayathri, 1Dr. B.Kavya Chowdary,1Dr.M.Anuhya, 2Dr.C. Pradeep,3Dr. G. V. Nagaraju ,4 Dr.Md.K.Rahman, 4Dr. Alias Kenny. 1,4 Clinical Pharmacist, Help Hospital, Vijayawada, Andhra Pradesh, India. 2 Dept.of General Medicine, Pradeep Diabetic Centre, Rajahmundry, Andhra Pradesh, India 3 Dept. of Pharmacy Practices, Koringa College of Pharmacy, Kakinada, A.P, India. Abstract To compare the safety and efficacy of the Teneligliptin a DPP inhibitor over other hypoglycaemic agents in Type II Diabetes Mellitus. .It is a prospective –observational study in this study was conducted at, Pradeep Diabetic Centre, Rajamahendravaram and the study was carried out for a period of 6 months from Feb 2016 to July 2016, and we are taking total of 114 patients with type 2 diabetes, in our study concludes the combination of Teneligliptin with other oral hypoglycaemic agents have been shown to improve glycaemic control efficiently when compare with the monotherapy shown inadequate glycaemic control. Patients of either gender and above 12 years, Patients diagnosed with type-II diabetes, Patients prescribed with oral hypo glycaemic agents as monotherapy, combination of oral hypoglycaemic agents along with insulin. The data and laboratory reports were collected from the case sheets of the patients and relevant sources. In this study was carried out by considering the collecting of socio demographic data of the patients such as age, gender, occupation, education and to obtain the information of patients receiving insulin as their ultimate therapy after receiving oral therapy and to assess the number, type and dose of oral hypoglycaemic drugs as prescribed and Dose of the insulin and other oral hypoglycaemic drugs that are shown in desirable therapeutic outcome or not. As well as we assess the state of their life style diet modifications after starting the therapy and compare the efficacy of Teneligliptin with combination of oral hypoglycaemic and monotherapy finally we assess the glycaemic laboratory reports of the patient before and after the treatment. In the data was analysed by applying statistics by SPSS (Statistical Package for the Social Sciences). Key Words: Teneligliptin, Hypoglycaemia, Case Study, 114 Patients, 6 Months. Corresponding Author: Dr. N.Tendu Pranadeep QR code Clinical Pharmacist, Help Hospital, Behind Victoria Museum, M.G.Road ,Vijayawada, Pin-520002A.P, India E-mail: [email protected] Mobile No-9966252747 Please cite this article in press N. Tendu Pranadeep et al., Safety and Efficacy of Teneligliptin over Other Hypoglycemic Agents In Type-2 Diabetes, Indo Am. J. P. Sci, 2018; 05(07). w w w . i a j p s . c o m Page 6325 IAJPS 2018, 05 (07), 6325-6340 N. Tendu Pranadeep et al ISSN 2349-7750 1.0 INTRODUCTION: currently diagnosed with the disease.1,2 In 2000, Diabetes mellitus is probably one of the oldest India (31.7 million) topped the world with the highest diseases known to man. It was first reported in Egypt number of people with diabetes mellitus followed by about 3000 years ago. In 1936, the distinction China (20.8 million) with the United States (17.7 between type- and type2 Diabetes mellitus was million) in second and third place respectively. clearly made. Type-II Diabetes mellitus was first According to Wild et al.3 the prevalence of diabetes described as a component of a metabolic syndrome in is predicted to double globally from 171 million in 1988.[1] Sushruta (6th century BCE) was the one 2000 to 366 million in 2030 with a maximum who identified diabetes and classified it as increase in India. It is also predicted that by 2030 Madhumeha .He further identified it with obesity and diabetes mellitus may afflict up to 79.4 million sedentary lifestyle, and also advising exercises which individuals in India, while China (42.3 million) and can help to "cure" it. The Indians tested for diabetes the United States (30.3 million) will also see by observing whether ants were attracted to a person's significant increases in those affected by the urine, , and called the disorder "sweet urine disease" disease.3,4 India currently faces an uncertain future (Madhumeha).[2]Diabetes mellitus (DM) is a chronic in relation to the potential burden that diabetes may metabolic disorder in which prevalence has been impose upon the country. The aetiology of diabetes in increasing steadily all over the world. As a result of India is multifactorial and includes genetic factors this trend, it is fast becoming an epidemic in many coupled with environmental influences such as countries of the world with the number of people obesity associated with rising living standards, steady affected expected to double in the next decade due to urban standards, steady urban migration, and lifestyle increase in ageing and population, thereby adding to changes. Obesity is one of the major risk factors for the already existing burden for healthcare providers, diabetes, yet there has been little research focusing on especially in poorly developed countries.[1]As at this risk factor across India. 6 Furthermore, Indians 2013, 382 million people have diabetes world wide . are genetically predisposed to the development of Type-II makes up about 90% of the cases. This is coronary artery disease due to dyslipidaemia and low equal to 8.3% of the adult population with equal rates levels of high density lipoproteins;14 these in both women and men.[3]In 2014, the International determinants make Indians more prone to Diabetes Federation (IDF) estimated that diabetes development of the complications of diabetes at an resulted in 4.9 million deaths. The World Health early age (20-40 years) compared with Caucasians Organization (WHO) estimated that diabetes resulted (>50 years) and indicate that diabetes must be in 1.5 million deaths in 2012, making it the 8th carefully screened and monitored regardless of leading cause of death . The discrepancy between the patient age within India.[6] two estimates is due to the fact that cardiovascular diseases are often the cause of death for individuals 1.2 Pathophysiology with diabetes; the IDF uses modelling to estimate the Normal regulation of glucose metabolism is amount of deaths that could be attributed to diabetes. determined by a feedback loop involving the islet β- More than 80% of diabetic deaths occur in low and cell and insulin-sensitive tissues in which tissue middle- income countries.[3]The first nationwide sensitivity to insulin determines the magnitude of the study on the prevalence of Type-II diabetes mellitus β-cell response. When insulin resistance is present, (T2DM) reported 2.1% and 1.5% prevalence in the the β-cell maintains normal glucose tolerance by urban and rural populations of India, respectively. [4] increasing insulin output. It is done only when the β- The present research work aims at the combination of cell is incapable of releasing sufficient insulin in the Teneligliptin with other oral hypoglycaemic agents presence of insulin resistance that glucose levels rise. have been shown to improve glycaemic control While β-cell dysfunction has a clear genetic efficient when compare with the monotherapy shown component, environmental changes play a vital inadequate glycaemic control of adult men and role.[7] woman over a region in Rajahmundry for a period of 6 months. This feedback loop relies on crosstalk between the β- cell and the insulin sensitive tissues . Insulin released 1.1 Diabetes in India in response to β-cell stimulation mediates the uptake India is the diabetes capital of the world with 41 of glucose, amino acids and fatty acids by insulin- million Indians having diabetes; every fifth diabetic sensitive tissues. In turn, these tissues feedback in the world is an Indian. It also leads in prevalence information to the islet regarding their need for of metabolic syndrome as well as obesity.[5]Diabetes insulin, the mediator of which has not yet been is fast gaining the status of a potential epidemic in identified but is likely to involve integration between India with more than 62 million diabetic individuals the brain and humoral systems. When insulin w w w . i a j p s . c o m Page 6326 IAJPS 2018, 05 (07), 6325-6340 N. Tendu Pranadeep et al ISSN 2349-7750 resistance is present, as seen most commonly with Metformin therapy for prevention of T2DM obesity, the β-cell increases its insulin output to may be considered in those patients meeting maintain normal glucose tolerance. However, when criteria for prediabetes. the β-cell is incapable of this task, the result is an At least annual monitoring for the elevation in plasma glucose.[7] development of diabetes in those with prediabetes may be utilized. Type-II diabetes results when pancreatic beta cells Screening for and treatment of modifiable are unable to secrete sufficient insulin to maintain risk factors for CVD are suggested.[10] normoglycemia,2nd typically in the context of Pharmacological therapy of Type-II diabetes has increasing peripheral insulin resistance.[8]Genes and changed dramatically in the last 10 years, with new the environment together are important determinants drugs and drug classes becoming available. These of insulin resistance and β- cell dysfunction. As our drugs allow for the use of combination oral therapy, gene pool has not changed in recent times, often with improvement of glycaemic control that environmental changes have been critical in was previously beyond the reach of medical therapy.
Recommended publications
  • Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix
    United States International Trade Commission Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix USITC Publication 4208 December 2010 U.S. International Trade Commission COMMISSIONERS Deanna Tanner Okun, Chairman Irving A. Williamson, Vice Chairman Charlotte R. Lane Daniel R. Pearson Shara L. Aranoff Dean A. Pinkert Address all communications to Secretary to the Commission United States International Trade Commission Washington, DC 20436 U.S. International Trade Commission Washington, DC 20436 www.usitc.gov Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix Publication 4208 December 2010 (This page is intentionally blank) Pursuant to the letter of request from the United States Trade Representative of December 15, 2010, set forth at the end of this publication, and pursuant to section 1207(a) of the Omnibus Trade and Competitiveness Act, the United States International Trade Commission is publishing the following modifications to the Harmonized Tariff Schedule of the United States (HTS) to implement changes to the Pharmaceutical Appendix, effective on January 1, 2011. Table 1 International Nonproprietary Name (INN) products proposed for addition to the Pharmaceutical Appendix to the Harmonized Tariff Schedule INN CAS Number Abagovomab 792921-10-9 Aclidinium Bromide 320345-99-1 Aderbasib 791828-58-5 Adipiplon 840486-93-3 Adoprazine 222551-17-9 Afimoxifene 68392-35-8 Aflibercept 862111-32-8 Agatolimod
    [Show full text]
  • CDR Clinical Review Report for Soliqua
    CADTH COMMON DRUG REVIEW Clinical Review Report Insulin glargine and lixisenatide injection (Soliqua) (Sanofi-Aventis) Indication: adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 units daily) alone or in combination with metformin. Service Line: CADTH Common Drug Review Version: Final (with redactions) Publication Date: January 2019 Report Length: 118 Pages Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services. While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document.
    [Show full text]
  • For the Use of a Registered Medical Practitioner Or a Hospital Or a Laboratory Only TENELIGLIPTIN, PIOGLITAZONE HYDROCHLORIDE AN
    For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only TENELIGLIPTIN, PIOGLITAZONE HYDROCHLORIDE AND PROLONGED RELEASE METFORMIN HYDROCHLORIDE TABLETS 1. THE DRUG SHOULD BE USED AT FIRST LINE OF THERAPY FOR DIABETES. 2. ADVICE FOR HEALTHCARE PROFESSIONALS • Patients with active bladder cancer or with a history of bladder cancer and those with uninvestigated haematuria should not receive pioglitazone. • Prescribers should review the safety and efficacy of pioglitazone in individuals after 3-6 month of treatment to ensure that only patients who are deriving benefit continue to be treated. Pioglitazone should be stopped in patients who do not respond adequately to treatment (e.g. reduction in Glycosylated haemoglobin HbA1C). • Before starting pioglitazone, the following known risk factors for development of bladder cancer should be assessed in individuals: age, current or past history of smoking, exposure to some occupational or chemotherapy agents such as cyclophosphamide, or previous irradiation of the pelvic region. • Use in elderly patients should be considered carefully before and during treatment because the risk of bladder cancer increases with age. Elderly patients should start on the lowest possible dose and be regularly monitored because of the risks of bladder cancer and heart failure associated with pioglitazone. COMPOSITION Each uncoated bilayered tablet contains: . 20 mg (InTeneligliptin Prolonged IP release .………………………..……………….. form) PioglitazoneMetformin Hydrochloride Hydrochloride IP IP …………………..…... equivalent to mg Pio . 15 mg .s Colour:glitazone Quinoline ………………………….…………………… Yellow Excipients ………………………….……………………..... q CLINICAL PHARMACOLOGY Biotenly®-MP contains three oral anti-hyperglycaemic drugs teneligliptin, pioglitazone and metformin hydrochloride used in the management of type-2 diabetes (NIDDM). MECHANISM OF ACTION/PHARMACODYNEMICS Teneligliptin is a DPP-4 inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones.
    [Show full text]
  • IJBCP International Journal of Basic & Clinical Pharmacology the Observational, Cross-Sectional Study of Drug Utilization
    Print ISSN: 2319-2003 | Online ISSN: 2279-0780 IJBCP International Journal of Basic & Clinical Pharmacology DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20194771 Original Research Article The observational, cross-sectional study of drug utilization 90% and use of dipeptidyl peptidase-4 inhibitor in the patients with type 2 diabetes mellitus Prashant P. Shivgunde1*, Shantanu R. Joshi2, Archana D. Kodilkar1 1Department of University Research, Maharashtra ABSTRACT University of Health Sciences (MUHS), Mhasrul, Vani- Background: Diabetes is a chronic metabolic disease which affects the quality Dindori Road, Nashik, of life. It leads to multiple complications due to metabolic involvement. Out of Maharashtra, India multiple drugs used to treat diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors 2 Global Herbs Pharmaceuticals, are comparatively new drugs used for type-2-diabetes mellitus (DM) treatment. Pune-Satara Road, Pune, This study aimed to find out the drug utilization (DU) 90% and use of DPP-4 Maharashtra, India inhibitors in patients with type-2-DM. Methods: A prospective, cross-sectional, observational study was conducted at Received: 28 September 2019 a private healthcare clinic of an endocrinologist in Nashik. Type-2-DM patients Revised: 11 October 2019 of both sexes were selected and a total of 199 patients were enrolled in the Accepted: 14 October 2019 study. The consented patients were interviewed and prescription copies were collected. After studying them; statistical analysis was done and results and *Correspondence to: conclusions were drawn. Dr. Prashant P. Shivgunde, Results: Out of total prescribed drugs, 58.77% of drugs were anti-diabetics. It Email: prashantshivgunde@ was observed that the biguanides were most frequently (25.32%) prescribed gmail.com while the least prescribed drugs were meglitinide analogues (0.08%).
    [Show full text]
  • Meta-Analysis of 11 Heterogeneous Studies Regarding Dipeptidyl Peptidase 4 Inhibitor Add-On Therapy for Type 2 Diabetes Mellitus Patients Treated with Insulin
    Hindawi Journal of Diabetes Research Volume 2020, Article ID 6321826, 12 pages https://doi.org/10.1155/2020/6321826 Research Article Meta-Analysis of 11 Heterogeneous Studies regarding Dipeptidyl Peptidase 4 Inhibitor Add-On Therapy for Type 2 Diabetes Mellitus Patients Treated with Insulin Katsuya Shibuki ,1,2 Shuji Shimada,1 and Takao Aoyama1 1Department of Pharmacy, Tokyo University of Science, 2641 Yamazaki, Noda 278-8510, Japan 2Clinical Research Center, Medical Hospital, Tokyo Medical and Dental University, 1-5-45 Yushima, Tokyo 113-8519, Japan Correspondence should be addressed to Katsuya Shibuki; [email protected] Received 6 April 2020; Revised 24 September 2020; Accepted 22 October 2020; Published 11 November 2020 Academic Editor: Daniela Foti Copyright © 2020 Katsuya Shibuki et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. Several clinical trials have addressed the therapeutic strategy of adding dipeptidyl peptidase 4 (DPP-4) inhibitors to the treatment of type 2 diabetes mellitus (DM) inadequately controlled by insulin therapy. However, there is a high degree of heterogeneity in these studies, and the cause of which has not been identified. Methods. We conducted a meta-analysis of randomized controlled trials, which compared the efficacy and safety of adding DPP-4 inhibitors or placebo to insulin therapy; the level of hemoglobin A1c (HbA1c) in the patients was >7.0%, and the duration of treatment was ≥8 weeks. We focused on the mean changes in HbA1c from the baseline (ΔHbA1c) and the incidence of hypoglycemia.
    [Show full text]
  • (SGLT2) Inhibitors: a Systematic Review and Meta-Analysis
    Open access Research BMJ Open: first published as 10.1136/bmjopen-2018-022577 on 1 February 2019. Downloaded from Comparative safety of the sodium glucose co-transporter 2 (SGLT2) inhibitors: a systematic review and meta-analysis Jennifer R Donnan,1 Catherine A Grandy,1 Eugene Chibrikov,1 Carlo A Marra,1,2 Kris Aubrey-Bassler,3 Karissa Johnston,1 Michelle Swab,3 Jenna Hache,1 Daniel Curnew,1 Hai Nguyen,1 John-Michael Gamble1,4 To cite: Donnan JR, Grandy CA, ABSTRACT Strengths and limitations of this study Chibrikov E, et al. Comparative Objective To estimate the association between the use safety of the sodium glucose of sodium glucose co-transporter-2 (SGLT2) inhibitors ► This study provides a comprehensive systematic co-transporter 2 (SGLT2) and postmarket harms as identified by drug regulatory inhibitors: a systematic review review of potential serious adverse events related agencies. and meta-analysis. BMJ Open to use of sodium glucose co-transporter-2 (SGLT2) Design We conducted a systematic review and meta- 2019;9:e022577. doi:10.1136/ inhibitors identified by drug regulatory agencies. analysis of randomised controlled trials (RCT). Six large bmjopen-2018-022577 ► This study considered select outcomes to provide databases were searched from inception to May 2018. focused attention on the issues concerning regula- ► Prepublication history and Random effects models were used to estimate pooled tors; however, this means that additional knowledge additional material for this relative risks (RRs). paper are available online. To of the clinical benefits and harms needs to be con- Intervention SGLT2 inhibitors, compared with placebo or view these files, please visit sidered before applying the results of this study.
    [Show full text]
  • Comparison of Dapagliflozin and Teneligliptin in Nonalcoholic Fatty
    Original Article ComparisonJCBNJournal0912-00091880-5086theKyoto,jcbn20-12910.3164/jcbn.20-129Original Society Japanof Article Clinical for Free Biochemistry Radical Research of and Nutrition Japandapagliflozin and teneligliptin in nonalcoholic fatty liver disease patients without type 2 diabetes mellitus: a prospective randomized study Hiroshi Tobita,1,2,* Tomotaka Yazaki,1,2 Masatoshi Kataoka,1,2 Satoshi Kotani,2 Akihiko Oka,2 Tsuyoshi Mishiro,2 Naoki Oshima,2 Kousaku Kawashima,2 Norihisa Ishimura,2 Kohji Naora,3 Shuichi Sato,4 and Shunji Ishihara2 1Division of Hepatology and 3Department of Pharmacy, Shimane University Hospital, 891 Enyacho, Izumo, Shimane 6938501, Japan 2Department of Internal Medicine II, Shimane University School of Medicine, 891 Enyacho, Izumo, Shimane 6938501, Japan 4Department of International Medicine, Izumo City General Medical Center, Izumo, Shimane 6938501, Japan (Received?? 10 August, 2020; Accepted 16 September, 2020; Published online 26 December, 2020) ThereCreativestrictedvidedCopyright2021This theare isuse, original anCommonsno opendistribution,© reports 2021 workaccess JCBNAttribution regarding is article andproperly reproduction distributed theLicense, cited. efficacy underwhichin ofany the sodiumglucose permitsmedium, terms ofunre- pro- the these patients.(9) cotransporter 2 inhibitor (SGLT2i) and dipeptidyl peptidase 4 Antidiabetic drugs are widely used for NAFLD patients with inhibitor (DPP4i) administrations in nonalcoholic fatty liver disease type 2 diabetes mellitus (T2DM).(10) Those include dipeptidyl
    [Show full text]
  • Treatment with DPP-4I Anagliptin Or A-GI Miglitol Reduces IGT Development and the Expression of CVD Risk Factors in OLETF Rats
    J Nutr Sci Vitaminol, 61, 313–321, 2015 Treatment with DPP-4I Anagliptin or a-GI Miglitol Reduces IGT Development and the Expression of CVD Risk Factors in OLETF Rats Chihiro IMAI1, Tomomi HARAZAKI1, Seiya INOUE1, Kazuki MOCHIZUKI1,2 and Toshinao GODA1,* 1 Laboratory of Nutritional Physiology, Graduate School of Integrated Pharmaceutical and Nutritional Sciences, University of Shizuoka, Shizuoka 422–8526, Japan 2 Laboratory of Food and Nutritional Sciences, Department of Local Produce and Food Sciences, Faculty of Life and Environmental Sciences, University of Yamanashi, Yamanashi 400–8510, Japan (Received November 26, 2014) Summary It has been reported that postprandial hyperglycemia from the pre-diabetic stage, especially from the impaired glucose tolerance (IGT) stage, is positively associated with subsequent incidences of cardiovascular diseases (CVD) and type 2 diabetes. In this study, we aimed to investigate whether treatment with a dipeptidyl peptidase-4 inhibitor (DPP-4I) or an a-glucosidase inhibitor (a-GI), either of which suppresses postprandial hyperglyce- mia, reduces the expression of CVD risk factors in an IGT animal model. A DPP-4I, ana- gliptin (1,200 ppm), or an a-GI, miglitol (600 ppm), in the diet was administered for 47 wk to Otsuka Long-Evans Tokushima Fatty (OLETF) rats, a model for spontaneously-developed type 2 diabetes, at the IGT stage. We examined whether each treatment reduced the expres- sion of CVD risk factors such as inflammatory cytokines/cytokine-like factors in peripheral leukocytes and adhesion molecules in the aortic tissues and circulation. Treatment with either drug reduced IGT development and repressed expression of the interleukin-1b, tumor necrosis factor-a, S100a9, and S100a11 genes in peripheral leukocytes in the fasting state at weeks 25 and 39.
    [Show full text]
  • Made in Its 40 Meeting Held on 09.11.2017 at CDSCO HQ New Delhi
    Recommendations of the SEC (Endocrinology & Metabolism) made in its 40thmeeting held on 09.11.2017 at CDSCO HQ New Delhi: Age File no./Drug Name Name of firm/ Recommendations nda Institute no. Subsequent New Drugs Division 1 12-116/2017-DC (Pt- Firm didn’t turn up for the presentation. Zydus-snd) M/s.Zydus Teneligliptin tablet 40mg add strength Biological Division 2 4- M/s.BioGenomi The firm presented the pre-clinical data and 438/BioGenomics/17 cs Ltd. Phase I PK/PD data generated in healthy BD volunteers. Recombinant insulin After detailed deliberation committee aspart observed that the request of the firm for Phase III clinical trial waiver cannot be considered. The committee recommended that the firm should submit Phase III clinical trial protocol for review. 3 4-42/Biocon/PAC-R- M/s. Biocon The firm presented their proposal for Insulin Glargine/17- Limited. approval for extension of age group in the BD already approved indication to “2 years and Insulin Glargine above” from “6 years and above”. After detailed deliberation, the committee recommended for approval of the proposed change. 4 4-436/Novo M/s. Novo The firm was not in position to present their Nordisk/17BD Nordisk India proposal so the case was deferred. Fast acting insulin Pvt. Ltd aspart 5 4- M/s. Novo The firm presented the supportive data 83/NovoNordisk/PAC Nordisk India including clinical data for the proposed -R-Liraglutide/17-BD Pvt. Ltd. expansion of the indication. Liraglutide Injection The committee after detailed deliberation, recommended that the indication may be expanded as follows: “To reduce the risk of major adverse cardiovascular events in adults with Type 2 diabetes mellitus and established cardiovascular disease”.
    [Show full text]
  • 2011/064352 Al
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date , , ,, , 3 June 2011 (03.06.2011) 201 1/064352 Al (51) International Patent Classification: (74) Agents: HAMMANN, Heinz et al; Boehringer Ingel A61K 31/155 (2006.01) A61K 31/519 (2006.01) heim GmbH, Corporate Patents, Binger Str. 173, 55216 A61K 31/44 (2006.01) A61K 45/06 (2006.01) Ingelheim am Rhein (DE). (21) International Application Number: (81) Designated States (unless otherwise indicated, for every PCT/EP20 10/068349 kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, (22) International Filing Date: CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, 26 November 2010 (26.1 1.2010) DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (25) Filing Language: English HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, (26) Publication Language: English ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (30) Priority Data: NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, 09177418.2 27 November 2009 (27.1 1.2009) EP SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, 10166714.5 2 1 June 2010 (21 .06.2010) EP TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (71) Applicant (for all designated States except US): (84) Designated States (unless otherwise indicated, for every BOEHRINGER INGELHEIM INTERNATIONAL kind of regional protection available): ARIPO (BW, GH, GMBH [DE/DE]; Binger Str.
    [Show full text]
  • Effect of Teneligliptin Vs Metformin on Glycemic Control in Indian Patients
    International Journal of Advances in Medicine Raghavan V et al. Int J Adv Med. 2019 Apr;6(2):481-488 http://www.ijmedicine.com pISSN 2349-3925 | eISSN 2349-3933 DOI: http://dx.doi.org/10.18203/2349-3933.ijam20191163 Original Research Article Effect of teneligliptin vs metformin on glycemic control in Indian patients with newly-diagnosed, drug-naïve type 2 diabetes mellitus: a 12-week randomized comparative clinical study Vijay Raghavan1, Apala Lahiri2, Akul S. K.3, Utpal Goswami4, Chandra Narayan Gupta2, Sukanta Sen5* 1Department of Community Medicine, 2Department of General Medicine, 3MBBS Student, 4Department of Pathology, 5Department of Pharmacology, ICARE Institute of Medical Sciences and Research, Banbishnupur, Purba Medinipur, Haldia, West Bengal, India Received: 25 January 2019 Accepted: 01 March 2019 *Correspondence: Dr. Sukanta Sen, E-mail: [email protected] Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT Background: This comparative study was done to evaluate the change from baseline in HbA1c levels with teneligliptin vs. metformin treatments at week 12 among recently diagnosed type 2 DM patients attending Medicine OPD of Dr. B. C. Roy Hospital, Haldia, West Bengal (a tertiary care teaching hospital). Methods: In this prospective parallel group clinical study patients were divided into two groups. Group A patients were on metformin monotherapy therapy and Group B patients were on teneligliptin monotherapy. Data of 40 patients (20 patients in each group) were available for analysis in the present study.
    [Show full text]
  • Role of Teneligliptin in Rural India As Add-On Third Drug in Patients with Type 2 Diabetes Mellitus
    International Journal of Advances in Medicine Gupta CN et al. Int J Adv Med. 2017 Apr;4(2):401-405 http://www.ijmedicine.com pISSN 2349-3925 | eISSN 2349-3933 DOI: http://dx.doi.org/10.18203/2349-3933.ijam20170966 Original Research Article Role of teneligliptin in rural India as add-on third drug in patients with type 2 diabetes mellitus Chandra Narayan Gupta1*, Vijay Raghavan2, Sukanta Sen3, Sanjay Kothari4 1Department of General Medicine, ICARE Institute of Medical Sciences and Research, Banbishnupur, P.O. Balughata, Purba Medinipur, Haldia, West Bengal- 721645, India 2Department of Community Mediicne, ICARE Institute of Medical Sciences and Research, Banbishnupur, P.O. Balughata, Purba Medinipur, Haldia, West Bengal- 721645, India 3 Department of Pharmacology, ICARE Institute of Medical Sciences and Research, Banbishnupur, P.O. Balughata, Purba Medinipur, Haldia, West Bengal- 721645, India 4Department of Radiology, ICARE Institute of Medical Sciences and Research, Banbishnupur, P.O. Balughata, Purba Medinipur, Haldia, West Bengal- 721645, India Received: 28 February 2017 Accepted: 03 March 2017 *Correspondence: Dr. Chandra Narayan Gupta, E-mail: [email protected] Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT Background: Teneligliptin was introduced in India in May 2015. It has gained popularity and is already widely prescribed in type 2 diabetes mellitus (T2DM). The main aim of our study was to assess the efficacy and superiority of teneligliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor as add-on third drug along with metformin and glimepiride in the treatment of type 2 diabetes mellitus in rural India.
    [Show full text]