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

Tracking Information

First Received Date ^ICMJE

February 12, 2007

Last Updated Date

September 14, 2009

Start Date ^ICMJE

February 2007

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00434954 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To compare the two injectable treatment regimens with respect to: [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
>proportion of patients achieving pre-specified HbA1c targets [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
>percentage of patients with at least one treatment-emergent hypoglycemic episode [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
>nocturnal hypoglycemia [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
>blood glucose control [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
>blood lipid levels [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
>anthropometric measures [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
>patient reported outcomes [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Drug: exenatide
Drug: insulin aspart

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

488

Completion Date

August 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00434954

Responsible Party

James Malone, MD, Study Director, Eli Lilly and Company

Study ID Numbers ^ICMJE

H8O-SB-GWBN

Study Sponsor ^ICMJE

Amylin Pharmaceuticals, Inc.

Collaborators ^ICMJE

Eli Lilly and Company

Investigators ^ICMJE

Study Director:

James Malone, MD

Eli Lilly and Company

Information Provided By

Amylin Pharmaceuticals, Inc.

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP