A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin. - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 17, 2007

Last Updated Date

April 15, 2009

Start Date ^†

Current Primary Outcome Measures ^†

Absolute change from baseline in HbAlc [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00423501 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Changes in lipid profile [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
AEs, laboratory parameters, primary pharmacokinetic parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Efficacy: absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon; changes in lipid profile. Safety: AEs, laboratory parameters. Pharmacokinetics: primary PK parameters.

Descriptive Information

Brief Title ^†

A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.

Official Title ^†

A Double Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Effect on Glycemic Control, Safety, Pharmacokinetics and Pharmacodynamics of GLP-1 in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

Brief Summary

This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^†

Diabetes Mellitus, Type 2

Intervention ^†

Drug: GLP-1
Drug: Placebo

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 ^†

Completed

Enrollment ^†

306

Completion Date

November 2007

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

adult patients, 18-75 years of age;
type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
stable weight +/-10% for >=3 months before screening.

Exclusion Criteria:

type 1 diabetes mellitus;
treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
use of weight-lowering medications in the last 3 months;
uncontrolled hypertension.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Australia, Bulgaria, China, Germany, Guatemala, Latvia, Lithuania, Mexico, Romania

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00423501

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Secondary IDs ^††

Study Sponsor ^†

Hoffmann-La Roche

Collaborators ^††

Investigators ^†

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.