OR49-2 Reduced Risk of Hypoglycemia with Insulin Degludec vs. Insulin Glargine in Type 2 Diabetes Patients with a BMI >30 kg/m2: a Meta-analysis of Five Randomized Trials

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: OR49-Insulin Therapy: Glycemic Control & Hypoglycemia
Clinical
Tuesday, June 18, 2013: 9:15 AM-10:45 AM
Presentation Start Time: 9:30 AM
Room 307 (Moscone Center)
Helena W Rodbard*1, Luigi Meneghini2, David Russell-Jones3, Rahul Kapur4, Lars Endahl4 and Athena Philis-Tsimikas5
1Endocrine and Metabolic Consultants, Rockville, MD, 2Univ of Miami Schl of Medcn, Miami, FL, 3Royal Surrey County Hospital, Guildford, United Kingdom, 4Novo Nordisk A/S, Søborg, Denmark, 5Scripps Whittier Diabetes Inst, La Jolla, CA
Background
Insulin degludec (IDeg), an ultra-long-acting basal insulin with a stable and consistent glucose-lowering effect, has been shown to be associated with significantly lower rates of overall (17%) and nocturnal (32%) hypoglycemia compared with insulin glargine (IGlar) in a pre-planned meta-analysis of patients with type 2 diabetes (T2D). In this post-hoc meta-analysis, we compared hypoglycemia rates for IDeg vs. IGlar in a subset of clinically obese T2D patients (BMI >30 kg/m2).

Methods
The meta-analysis included all five phase 3a, randomized, open-label, treat-to-target (FPG <90 mg/dL) clinical trials of 26 or 52 weeks' duration in which once-daily IDeg and IGlar have been compared. Patients were included in this post-hoc analysis if they had a BMI of >30 kg/m2 at screening. Analysis of HbA1c and FPG was based on an ANCOVA model; analysis of hypoglycemic episodes was based on a negative binomial regression model.

Results
The meta-analysis included 1,791 (IDeg: n=1,195; IGlar: n=596) patients with a BMI of >30 kg/m2 out of a total of 3,372 randomized patients. Treatment groups were similar with respect to end-of-trial mean HbA1c (NS), whereas IDeg was associated with a significantly greater reduction from baseline in mean FPG (estimated treatment difference: –7.0 mg/dL [–11.0; –3.1]; p<0.001). Daily insulin doses at end-of-trial were similar for IDeg (1.0 U/kg) and IGlar (0.9 U/kg). The rate of confirmed hypoglycemia (plasma glucose <56 mg/dL and severe episodes requiring assistance) was 22% lower with IDeg vs. IGlar (p<0.01); the rate of nocturnal confirmed hypoglycemia (onset from midnight to 6 AM) was 37% lower with IDeg vs. IGlar (p<0.001).

Conclusions
Consistent with the overall meta-analysis population, IDeg provides similar overall glycemic control to IGlar with a significantly lower rate of overall and nocturnal hypoglycemia in obese T2D patients with a BMI >30 kg/m2.

Disclosure: HWR: Speaker Bureau Member, Astra Zeneca, Advisory Group Member, Biodel, Consultant, Biodel, Research Funding, Biodel, Advisory Group Member, Bayer, Inc., Speaker Bureau Member, Bristol-Myers Squibb, Research Funding, Boehringer Ingelheim, Speaker Bureau Member, Boehringer Ingelheim, Research Funding, Eli Lilly & Company, Speaker Bureau Member, Eli Lilly & Company, Research Funding, Merck & Co., Speaker Bureau Member, Merck & Co., Research Funding, Novartis Pharmaceuticals, Advisory Group Member, Novo Nordisk, Research Funding, Novo Nordisk, Speaker Bureau Member, Novo Nordisk, Advisory Group Member, Roche Diagnostics, Consultant, Roche Diagnostics, Research Funding, Roche Diagnostics, Advisory Group Member, Sanofi, Research Funding, Sanofi, Consultant, Lifescan, Consultant, Merck & Co., Consultant, Halozyme, Consultant, Amylin Pharmaceuticals, Consultant, Bristol-Myers Squibb, Consultant, Astra Zeneca, Consultant, Mannkind, Research Funding, Astra Zeneca, Advisory Group Member, Astra Zeneca, Speaker Bureau Member, Amylin Pharmaceuticals, Advisory Group Member, Amylin Pharmaceuticals. LM: Advisory Group Member, Sanofi, Consultant, Novo Nordisk, Consultant, Sanofi, Research Funding, Mannkind, Research Funding, Pfizer, Inc., Research Funding, Bayer, Inc., Research Funding, Biodel, Advisory Group Member, Novo Nordisk. DR: Speaker Bureau Member, Eli Lilly & Company, Research Funding, Serono, Research Funding, Boehringer Ingelheim, Research Funding, Novo Nordisk, Research Funding, Eli Lilly & Company, Consultant, Novo Nordisk, Consultant, Eli Lilly & Company, Advisory Group Member, Novo Nordisk, Advisory Group Member, Eli Lilly & Company, Speaker Bureau Member, Novo Nordisk, Speaker Bureau Member, Sanofi. RK: Employee, Novo Nordisk, Employee, Novo Nordisk. LE: Employee, Novo Nordisk, Employee, Novo Nordisk. AP: Research Funding, Eli Lilly & Company, Research Funding, Sanofi, Research Funding, Novo Nordisk, Research Funding, Merck & Co., Research Funding, Daiichi Sankyo, Research Funding, Takeda, Advisory Group Member, Merck & Co., Advisory Group Member, Sanofi, Advisory Group Member, Novo Nordisk, Research Funding, Amylin Pharmaceuticals, Research Funding, Astra Zeneca, Research Funding, Pfizer, Inc..

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm