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

NCT00423501 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2016-11-02

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

Placebo

sc weekly

DRUG

taspoglutide

20mg sc weekly

DRUG

taspoglutide

10mg sc every 2 weeks

DRUG

taspoglutide

5mg sc weekly

DRUG

taspoglutide

10mg sc weekly

DRUG

taspoglutide

20mg sc every 2 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • United States
  • Australia
  • Bulgaria
  • Germany
  • Guatemala
  • Hong Kong
  • Latvia
  • Lithuania
  • Mexico
  • Romania

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00423501 on ClinicalTrials.gov