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A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy

NCT01051011 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2016-11-02

No results posted yet for this study

Summary

This randomized, open-label, parallel arm study will compare the safety, tolerability and effect on glycemic control of taspoglutide versus insulin glargine in insulin-naïve patients with type 2 diabetes mellitus inadequately controlled on merformin and sulfonylurea combination therapy. Patients will be randomized to receive either taspoglutide 10mg subcutaneously (sc) weekly, or taspoglutide 10mg sc weekly for 4 weeks followed by 20mg sc weekly, or insulin glargine at an initial dose of 10 international units sc daily. Metformin treatment will be continued in all patients throughout the study, whereas sulfonylurea will be discontinued before starting study treatment. Anticipated time on study treatment is 24 weeks, with an option to continue the assigned treatment for another 28 weeks. Target sample size is 500-600 patients.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

insulin glargine

initial dose 10 international units (IU) sc daily, titrated according to the mean FPG, 24 (-52) weeks

DRUG

metformin

as prescribed

DRUG

taspoglutide

10mg sc weekly, 24 (-52) weeks

DRUG

taspoglutide

10mg sc weekly the 1st 4 weeks followed by 20mg sc weekly, 24 (-52) weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • China
  • Hong Kong
  • Malaysia
  • Philippines
  • South Korea
  • Taiwan
  • Thailand

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 NCT01051011 on ClinicalTrials.gov