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

Study identifier:H8O-SB-GWBN

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 3

Healthy volunteers

No

Study drug

exenatide twice daily (BID), premixed insulin aspart twice daily (BID)

Sex

All

Actual Enrollment

494

Study type

Interventional

Age

18 Years - 90 Years

Date

Study Start Date: 01 Feb 2007
Primary Completion Date: 01 Jun 2009
Study Completion Date: 01 Jun 2009

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

Eli Lilly and Company

Inclusion and exclusion criteria