Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

Study identifier:H8O-MC-GWAO

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Efficacy of Exenatide Compared with Insulin Glargine in Patients with Type 2 Diabetes Using Metformin or Sulfonylurea for Whom Insulin is the Next Appropriate Therapy

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 3

Healthy volunteers

Study drug

exenatide/insulin glargine, insulin glargine/exenatide

Sex

All

Actual Enrollment

138

Study type

Interventional

Age

30 Years +

Date

Study Start Date: 01 Sept 2004

Primary Completion Date: 01 Aug 2005

Study Completion Date: 01 Aug 2005

Study design

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

Verification:

Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals

Collaborators

Eli Lilly and Company

Inclusion and exclusion criteria

Location

Research Site

Fullarton, SA, Australia

Location

Research Site

Daw Park, SA, Australia

Location

Research Site

Box Hill, VIC, Australia

Location

Research Site

Westmead, NSW, Australia

Location

Research Site

East Ringwood, VIC, Australia

Location

Research Site

Lublin, Poland

Location

Research Site

Bydgoszcz, Poland

Location

Research Site

Gdansk, Poland

Arms	Assigned Interventions
Experimental: exenatide/insulin glargine Arm that first receives exenatide, then crosses over to insulin glargine	Drug: exenatide/insulin glargine Subcutaneously injected exenaide 10 mcg twice daily for 16 weeks; then insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels Other Name: Byetta Other Name: AC2003 Other Name: syntheitc exenden-4
Experimental: Insulin glargine/exenatide Arm that first receives insulin glargine, then crosses over to exenatide	Drug: insulin glargine/exenatide Subcutaneously injected insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels; then exenaide 10 mcg twice daily for 16 weeks Other Name: Byetta Other Name: AC2993 Other Name: synthetic exenden-4

Documents available

Link to study results on ClinicalStudyResults.org
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center null

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

James Malone

Eli Lilly and Co.

Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

Link to study results on ClinicalStudyResults.org

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator