Recommendations of the SEC (Endocrinology & Metabolism) Made in Its 55Thmeeting Held on 21.05.2019 at CDSCO HQ New Delhi: Ag

Total Page:16

File Type:pdf, Size:1020Kb

Recommendations of the SEC (Endocrinology & Metabolism) Made in Its 55Thmeeting Held on 21.05.2019 at CDSCO HQ New Delhi: Ag Recommendations of the SEC (Endocrinology & Metabolism) made in its 55thmeeting held on 21.05.2019 at CDSCO HQ New Delhi: Agenda File Name & Drug Name, Firm Name Recommendations No Strength Introductory Remarks FDC Division 1. 4-27/2012-DC (Pt. Sun) M/s. Sun In light of recommendation of the Voglibose IP Pharma Committee dated 29.11.2018, the firm 0.2mg/0.2mg/0.3mg/0.3mg+ Laboratories presented their justification as follows: Glimipiride IP 1) The firm has conducted the 1mg/2mg/1mg/2mg+Metfor clinical trial as per the approved min Hydrochloride (SR) protocol. 500mg/500mg/500mg/500m 2) Comparative arms of the study g uncoated bilayered tablets protocol were not comparable in terms of dosage of Metformin. Therefore, the outcome of study was non-inferior. 3) The same combination is already marketed in the country by various firms. 4) Prof. Kokate Committee had earlier examined this FDC for other firms and classified the said FDC as category “D” recommending for conducting Phase IV clinical trial. After detailed deliberation the Committee recommended that the firm should conduct Phase IV clinical trial for which protocol should be submitted for review of their application for manufacturing permission of the product. 2. 4-56/2018-DC M/s. In light of the earlier recommendations Teneligliptin Hydrobromide Synokem of the committee dated 19.02.2019, the Hydrate eq. to Teneligliptin firm presented the raw data. The 20mg/20mg + Pioglitazone committee noted that there is a gross Hydrchloride eq. to inconsistency in the laboratory results of Pioglitazone 15mg/30mg patient no. 1 compromising the reliability film coated tablets of the data of the study. Therefore the committee recommended to repeat the bioequivalence study with the already approved protocol. 3. FDC/MA/19/000021 M/ s Stanfod The firm made a detailed presentation Pyridoxine HCL+Myo- Laboratories before the committee. The committee Ionositol+ChromiumPolynic noted that there is no scientific evidence otinate+Folicacid+Benfotiam for this FDC for the proposed ine(3mg+100mg+200mg+1.5 indications. Hence the committee didn’t 00mg+200mg+1500mcg)Tab recommend for approval. lets 55thSEC (Endocrinology &Metabolism) _21.05.2019 Agenda File Name & Drug Name, Firm Name Recommendations No Strength GCT Division 4. CT/64/15 Novo The firm presented their proposal for NNC0195-0092 Nordisk protocol amendment including long term extension trial. After detailed deliberation, the committee recommended for approval of the protocol amendment. 5. CT/09/19 M/s Sanofi In light of recommendation of the SAR341402 Mix 70/30 to committee dated 19.03.2019, the firm Novo Mix @30 presented their justification for waiver of PK/PD study & upper age limit of 65 years in the proposed clinical trial. The committee after detailed deliberation reiterated its earlier recommendation that PK/PD study should be conducted in Indian subjects as part of the trial. The committee however recommended for relaxation of upper age limit of 65 years subject to condition that the firm should ensure stringent monitoring of such subjects in the trial. The committee recommended for grant of permission to conduct the trial with above conditions. Dr. Rajesh Rajput and Dr. Deepak Khandelwal did not participated in the deliberation. 6. IQVIA-RDS Applicant presented their proposal for CT/26/19 Phase IV clinical trial along with study Insulin Glargine protocol before the committee. After detailed deliberation the committee recommended for grant of permission to conduct the study subject to following conditions: 1. The study should be conducted with 300 subjects from India. 2. The PI at each site should have minimum qualification MD (Medicine)/DNB (Medicine). 3. The cost of study drugs, investigations & other expenses in the trial should be borne by the sponsor/applicant. BABE Division 7. Firm presented the BE study protocol 12-09/2019/BA-BE/Misc- M/s. before the committee for export purpose. 23/DC Aurobindo After detailed deliberation, committee Hydrocortisone Modified Pharma recommended for conducting the Release Tablets 5mg proposed study with the condition that 55thSEC (Endocrinology &Metabolism) _21.05.2019 Agenda File Name & Drug Name, Firm Name Recommendations No Strength the PI should be MD (Pharmacology)/MD(Medicine). 8. Firm presented the BE study protocol before the committee for export purpose. 12-09/2019/BA-BE/Misc- M/s. After detailed deliberation, committee 24/DC Aurobindo recommended for conducting the Hydrocortisone Modified Pharma proposed study with the condition that Release Tablets 20mg the PI should be MD (Pharmacology)/MD(Medicine). Biological Division 9. The firm presented their proposal to update the package insert. After detailed 4-72/Novo Nordisk/PAC-R- Novo deliberation, committee recommended XULTOPHY/17-BD Nordisk that the firm should add the relevant information presented before the committee, under clinical section of Xultophy. 10. The firm presented their PMS protocol before the committee. However, the committee noted that the firm was accorded marketing authorization with a Novo 2/Phase IV/NovoNordisk/19- condition to conduct Phase IV study. Nordisk BD After detailed deliberation, committee recommended that the firm should revise the protocol for Phase IV clinical trial and submit the same for review within next 3 months. 55thSEC (Endocrinology &Metabolism) _21.05.2019 .
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]
  • 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.
    [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]