MedTrace Logo

A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.

NCT00754988 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 666

Last updated 2016-11-04

No results posted yet for this study

Summary

This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

Metformin

As prescribed

DRUG

Placebo (matching sitagliptin)

Once daily oral administration of placebo (matching sitagliptin).

DRUG

Placebo (matching taspoglutide)

Once weekly subcutaneous (sc) injection of placebo (matching taspoglutide).

DRUG

Sitagliptin

Once daily oral administration of 100 mg of sitagliptin.

DRUG

Taspoglutide

Once weekly subcutaneous (sc) injection of 10 mg or 20 mg of taspoglutide.

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
2008-10-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • France
  • Germany
  • Greece
  • Mexico
  • Norway
  • Peru
  • Poland
  • Puerto Rico
  • Romania
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • 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 NCT00754988 on ClinicalTrials.gov