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When Intensive Insulin Therapy (MDI) S180 Diabetes Care Volume 39, Supplement 2, August 2016 1 2 INSULIN THERAPY Ohad Cohen, Sebastiano Filetti, When Intensive Insulin Therapy Javier Castaneda,~ 3 Marianna Maranghi,2 (MDI) Fails in Patients With and Mariela Glandt4 Type 2 Diabetes: Switching to GLP-1 Receptor Agonist Versus Insulin Pump Diabetes Care 2016;39(Suppl. 2):S180–S186 | DOI: 10.2337/dcS15-3029 Treatment with insulin, alone or with oral or injectable hypoglycemic agents, is becoming increasingly common in patients with type 2 diabetes. However, approximately 40% of patients fail to reach their glycemic targets with the initially prescribed regimen and require intensification of insulin therapy, which increases the risks of weight gain and hypoglycemia. Many of these patients eventually reach a state in which further increases in the insulin dosage fail to improve glycemic control while increasing the risks of weight gain and hypoglycemia. The recently completed OpT2mise clinical trial showed that continuous subcutaneous insulin infusion (CSII) is more effective in reducing glycated hemoglobin (HbA1c) than intensification of multiple daily injection (MDI) insulin therapy in patients with type 2 diabetes who do not respond to intensive insulin therapy. CSII therapy may also be useful in patients who do not reach glycemic targets despite multi- drug therapy with basal-bolus insulin and other agents, including glucagon-like peptide (GLP)-1 receptor agonists; current guidelines offer no recommendations for the treatment of such patients. Importantly, insulin and GLP-1 receptor ago- nists have complementary effects on glycemia and, hence, can be used either sequentially or in combination in the initial management of diabetes. Patients 1 who have not previously failed GLP-1 receptor agonist therapy may show reduc- Sheba Medical Center, Tel Hashomer, Israel 2Dipartimento di Medicina Interna e Specialita` tion in weight and insulin dose, in addition to moderate improvement in HbA1c, Mediche, Sapienza University, Rome, Italy when GLP-1 receptor agonist therapy is added to MDI regimens. In subjects with 3Medtronic Bakken Research Center, Maastricht, long-standing type 2 diabetes who do not respond to intensive insulin therapies, the Netherlands 4 switching from MDI to CSII and/or the addition of GLP-1 receptor agonists to MDI have Department of Internal Medicine, Bronx-Lebanon Hospital, Bronx, NY, and Center for Diabetes Care, the potential to improve glycemic control without increasing the risk of adverse events. Tel Aviv, Israel Corresponding author: Ohad Cohen, ohad.cohen@ Type 2 diabetes is a progressive disease caused by increasingly severe b-cell dys- sheba.health.gov.il. function (1). Preventive strategies have been unsuccessful in curbing the increase This publication is based on the presentations in the prevalence of the disease (2), and although more than 10 classes of hypogly- at the 5th World Congress on Controversies to Consensus in Diabetes, Obesity and Hyperten- cemic medications have been developed to treat type 2 diabetes, none have been sion (CODHy). The Congress and the publication shown to ensure robust, sustained glycemic control over the course of the disease of this supplement were made possible in (3). As a result, increasing numbers of patients are being treated with insulin alone part by unrestricted educational grants from or, more commonly, as an adjunct to oral or injectable hypoglycemic therapy. AstraZeneca. However, ;40% of patients treated with this approach fail to achieve their glycated © 2016 by the American Diabetes Association. Readers may use this article as long as the work is hemoglobin (HbA1c) targets with basal insulin therapy and require additional treat- properly cited, the use is educational and not for ment with boluses of short-acting insulin preparations (4). Unfortunately, in some profit, and the work is not altered. care.diabetesjournals.org Cohen and Associates S181 patients, these intensified insulin regi- the two trials with parallel-group designs, insulin resistant and had HbA1c levels mens also eventually prove to be inef- the benefits of pump therapy were simi- that remained .8% (64 mmol/mol) af- fective in ensuring glycemic control, and lar to those of intensified MDI treatment ter $3 months of aggressive multidrug they often increase the risk of adverse (7,8), whereas the two randomized cross- treatment. This treatment included at events such as weight gain and hypogly- over studies (9,10) found that pump least three daily injections of insulin cemia (5). The mechanisms underlying treatment was superior to MDI. analogs (rapid- and long acting) and an this loss of response have not been ex- A larger randomized controlled trial, additional 2-month period of dose titra- tensively studied. OpT2mise (6), was designed to resolve tion to a minimum total dose of 0.7 When a multiple daily injection (MDI) this discrepancy. In this study, .300 pa- units/kg/day (12). The characteristics regimen fails to achieve the target tients in whom adequate glycemic con- of these patients, which are shown in HbA1c, there are some options available trol was not achieved despite optimized Table 1, are similar to those of patients to patients, including adding glucagon- MDI therapy were randomized to ongo- with type 2 diabetes who have benefited like peptide 1 (GLP-1) receptor agonists ing treatment with either optimized MDI from CSII in French cohort studies (GLP-1 RAs), adding sodium–glucose insulin therapy or CSII. After 6 months of (13,14): late-middle-aged individuals cotransporter 2 inhibitors, or undergo- treatment, the mean (SD) HbA1c level had with long-standing diabetes, level I obe- ing bariatric surgery. The recently com- decreased by 1.1 (1.2)% (12 [13] mmol/mol) sity, and a mean HbA1c level that re- pleted randomized, open-label trial in the CSII group compared with only 0.4 mains above the target range, despite OpT2mise (6) has provided evidence (1.1)% (4 [12] mmol/mol) in the MDI aggressive treatment. that continuous subcutaneous insulin groupda highly significant difference of Patients of this type are by no means infusion (CSII) is more effective in reduc- –0.7% (95% CI –0.9 to –0.4) (–8 mmol/mol rare in routine clinical practice. In fact, ing HbA1c levels than intensification of [95% CI –10 to –4]), P , 0.0001). The the Swedish National Diabetes Register MDI insulin therapy in patients with improved glycemic control achieved (the world’s most comprehensive na- type 2 diabetes in whom adequate gly- with pump therapy was independent of tional diabetes registry) recently report- cemic control cannot be achieved with age, sex, cognitive state, fasting C-peptide ed that HbA1c levels .8.8% (73 mmol/mol) intensive basal-bolus insulin regimens. levels, and anti-GAD antibody status. In are present in almost 1 in 10 patients This article will focus on two of these addition, insulin doses in the pump therapy with type 2 diabetes and .1 in 5 of those options: adding GLP-1 RA to MDI and group were 20% lower than those of the being treated in specialist clinics. Fur- switching from MDI to CSII. group managed with MDI, and no significant thermore, most of these individuals are We performed a literature review to between-group differences were observed already being treated with insulin, alone identify published studies in English of in the rates of severe adverse events or hy- or with other hypoglycemic medica- patients with type 2 diabetes treated poglycemia, which were low in both cases. tions (15). Of note, CSII as replacement with MDI and failing to reach glycemic of MDI for intensive insulin therapy has goals using the following MeSH (Medical WHAT KIND OF PATIENTS WITH safety concerns with respect to cardio- Subject Headings) terms search string: TYPE 2 DIABETES MIGHT BE vascular and all-cause mortality similar (“diabetes mellitus, type 2”[MeSH EXPECTED TO BENEFIT FROM A to those of MDI, as discussed in recent Terms] OR “type 2 diabetes mellitus”[All SWITCH FROM MDI TO PUMP publications (16,17). Fields] OR “diabetes mellitus type 2”[All THERAPY? Fields]) AND (mdi[All Fields] OR (multi- Type 2 diabetes is a heterogeneous WHAT ARE THE PATIENT ple[All Fields] AND daily[All Fields] AND disease at both the phenotype and ge- EDUCATION NEEDS NECESSARY (“injections”[MeSH Terms] OR “injec- notype levels. Interactions between FOR CSII TREATMENT IN TYPE 2 tions”[All Fields]))) AND (“2006/02/ genetic, environmental, and behavioral DIABETES? 09”[PDat]: “2015/02/06”[PDat]). A total factorsdnot to mention those related Device handling for patients with type 2 of 112 hits were identified by the to the microbiota (11)dresult in sub- diabetes with age- and diabetes-related PubMed search; 91 references were stantial phenotypic variability, and, as cognitive and dexterity decline might be excluded. Of the remaining 18 articles, noted above, this variability is reflected complicated with current pump devices 4 were on the addition of pioglitazone, in the heterogeneous responses to dif- (5). In the OpT2mise study, patients as- acarbose empagliflozin, and sitagliptin ferent drugs. This is the reason so much signed to pump treatment underwent (1 article per drug); 2 on the addition of emphasis is currently being placed on up to 3 weeks’ training with additional GLP-1 RAs; and 15 on CSII in type 2 diabetes. the importance of “precision medi- visits (6). Simplifying future pumps and cine,” whereby therapy is tailored to related procedures with use of prefilled WHAT EVIDENCE DO WE HAVE the specific needs and characteristics cartridges can potentially be advanta-
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