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A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes

NCT00909597 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 756

Last updated 2016-11-02

No results posted yet for this study

Summary

This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

pioglitazone

30mg po once daily for 4 weeks, followed by 45mg once daily

DRUG

taspoglutide

10mg sc once weekly

DRUG

taspoglutide

10mg sc once weekly for 4 weeks, followed by 20 mg 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
2009-05-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Costa Rica
  • France
  • Germany
  • Mexico
  • New Zealand
  • Peru
  • Poland
  • Puerto Rico
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • Thailand
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00909597 on ClinicalTrials.gov