Continuous subcutaneous delivery of exenatide via ITCA 650 leads to sustained glycemic control and weight loss for 48 weeks in metformin-treated subjects with type 2 diabetes☆☆,

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Abstract

Aims

Evaluate the efficacy and tolerability of ITCA 650 in subjects with type 2 diabetes treated for up to 48 weeks.

Methods

This was a 24-week extension to a randomized, 24-week, open-label, phase 2 study in subjects with type 2 diabetes inadequately controlled with metformin. Subjects received ITCA 650 mg (20, 40, 60 or 80 μg/day). Mean changes for HbA1c, weight, and fasting plasma glucose (FPG) were evaluated.

Results

Mean changes in HbA1c from baseline to week 48 ranged from − 0.85% to − 1.51%. At week 48, ≥ 64% of subjects with an HbA1c ≤ 7% at week 24 maintained an HbA1c ≤ 7%. The incidence of adverse events (AEs) was dose-related and ranged from 13.3% with 20 μg/day to 37.5% with 80 μg/day. Most AEs were mild and transient; the incidence of nausea declined from 12.9% to 9.5% over the 24-week extension. One subject on ITCA 650 80 μg/day experienced mild intermittent vomiting. Three (3.5%) subjects experienced severe AEs, but none were considered related to study drug.

Conclusion

Significant changes in HbA1c, body weight, and FPG attained with ITCA 650 were maintained to 48 weeks. The incidence of AEs was lower in the 24-week extension than in the initial 24-week treatment phase.

Keywords

Exenatide
ITCA 650
Type 2 diabetes

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☆☆

These results were presented as an abstract at the European Association for the Study of Diabetes Annual Meeting, Lisbon, Portugal, September 14, 2011.

Conflict of interest: R.R.H. is a government employee who received financial support to conduct the study, serves as a consultant and/or on the Advisory Board for Amgen, AstraZeneca, Intarcia Therapeutics, Inc., Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Eli Lilly and Company, Johnson & Johnson, Novo Nordisk Inc., Merck, Roche/Genentech, Sanofi, Medtronic, Daiichi Sankyo, and Elcelyx Therapeutics Inc., and has received grant/research support as the principle investigator from AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, Sanofi, and Medtronic. J.R. received financial support to conduct the study, has served on scientific advisory boards and received honoraria/consulting fees from Amylin Pharmaceuticals, Inc., Boehringer Ingelheim Pharmaceuticals, Daiichi Sankyo, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, MannKind Corporation, Novartis, Novo Nordisk, Pfizer, Inc., Roche, Sanofi, and Takeda Pharmaceuticals North America, Inc., and has also received grants/research support from Amylin Pharmaceuticals, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly and Company, Forest Laboratories, GlaxoSmithKline, Johnson & Johnson, MannKind Corporation, Merck, Novartis, Novo Nordisk, Pfizer, Inc., Roche, Sanofi, and Takeda Pharmaceuticals North America, Inc. D.L. is an employee of Medpace, which was the contract research organization for this trial. T.A. and M.A.B. are employees of Intarcia Therapeutics, Inc. K.L. was an employee of Intarcia Therapeutics, Inc. at the time this study was conducted. No other potential conflicts of interest relevant to this article were reported.