Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: exenatide (Drug); insulin aspart (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Amylin Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
James Malone, MD, Study Director, Affiliation: Eli Lilly and Company

Overall contact:
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.

Official title: Effect of Exenatide Plus Metformin vs. Premixed Human Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Inadequate Control of Type 2 Diabetes on Oral Antidiabetic Treatment

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To test the hypothesis that exenatide is non-inferior to premixed human insulin aspart in terms of glycemic control, and superior to premixed human insulin aspart in terms of hypoglycemia incidence, when given in combination with metformin.

Secondary outcome:

To compare the two injectable treatment regimens with respect to:

>proportion of patients achieving pre-specified HbA1c targets

>percentage of patients with at least one treatment-emergent hypoglycemic episode

>nocturnal hypoglycemia

>blood glucose control

>blood lipid levels

>anthropometric measures

>patient reported outcomes

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Have been treated with diet and exercise and a stable, maximally tolerated dose of

immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start

- Have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than

2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start

- Have an HbA1c between 6. 5% and 10. 0%, inclusive

- Have a body mass index (BMI) between 25 kg/m^2 and 40 kg/m^2, inclusive

Exclusion Criteria:

- Have type 1 diabetes or known latent autoimmune diabetes in adults

- Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy

(excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start

- Are receiving treatment for gastrointestinal disease with a drug directly affecting

gastrointestinal motility (e. g., metoclopramide, cisapride, and chronic macrolide antibiotics)

- Have used any prescription drug to promote weight loss within 3 months prior to study

start

- Have received treatment within 30 days prior to study start with a drug that has not

received regulatory approval for any indication at the time of study entry

- Have previously completed or withdrawn from this study or any other study

investigating exenatide or GLP-1 analogs

Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Leipzig, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Schwedt/Oder, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Unterhaching, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Bosenheim, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Hirschhorn, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Warburg, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Jena, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Friedrichsthal, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Essen, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Wangen, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Mannheim, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Hildesheim, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Lehrte, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Berlin, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Biberach, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Wallerfing, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Neuburg, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Volklingen, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Roding, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Munchen, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Regensburg, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Datteln, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Riesa, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Meissen, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Rosenheim, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Rodgau, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Hohenmolsen, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Pohlheim, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Speyer, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Simmern, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Schluchtern, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Oschatz, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Ludwigsburg, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Bad Mergentheim, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Wiesbaden, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Offenbach, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Wolfsburg, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Burghausen, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Dresden, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Marburg, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Sinsheim, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Research Site, Marktheidenfeld, Germany; Recruiting
Lilly Clinical Trials Support Center, Phone: 1-877-CTLILLY (1-877-285-4559)

Starting date: February 2007
Ending date: July 2009
Last updated: June 26, 2008