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A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy

NCT00823992 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2016-07-28

No results posted yet for this study

Summary

This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly) The anticipated time on study treatment is 12 months, and the target sample size is 100-500 individuals.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

placebo

sc once weekly

DRUG

taspoglutide

10mg sc once weekly for 4 weeks, then 20mg sc once weekly

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
2009-01-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States
  • Canada
  • Germany
  • Italy
  • North Macedonia
  • Poland
  • Puerto Rico
  • Russia
  • Spain
  • United Kingdom

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 NCT00823992 on ClinicalTrials.gov