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Trial · Interventional

CompletedPhase 3Registry data

A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.

NCTNCT00717457 (opens ClinicalTrials.gov in a new tab)Other idBC21625Other id2008-001856-36Other id2008
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
1,189 participants (actual)
Sponsor
Hoffmann-La Roche · Industry
Design
Randomized · Open label (no masking)
Countries
26 countries

United States, Argentina, Australia, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Guatemala, Israel, Italy, Mexico, New Zealand, Peru, Puerto Rico, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Ukraine, United Kingdom

Start
Jul 2008
Primary completion
Mar 2011
Completion
Mar 2011
First posted
17 Jul 2008 (estimated)
Last update posted
2 Nov 2016 (estimated)
Conditions
Diabetes Mellitus Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082009201020112012
  1. Ph 3

    A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.

    NCT00717457

    Jul 2008 to Mar 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is \>500 individuals.

Interventions

  • exenatideDrug
  • taspoglutideDrug
  • taspoglutideDrug

Arms3

  • Active comparator

    exenatide

  • Experimental

    taspoglutide 10mg

  • Experimental

    taspoglutide 10mg/20mg

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c

    Time frame · 24 weeks

Secondary outcomes(4)

  1. Fasting body weight

    Time frame · 24 weeks

  2. Proportion of patients reaching target HbA1c <=7.0%, <=6.5%

    Time frame · 24 weeks

  3. Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients.

    Time frame · 24 weeks

  4. Beta cell function (proinsulin/insulin ratio)

    Time frame · 24 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2013

15 results

The fate of taspoglutide, a weekly GLP-1 receptor agonist, versus twice-daily exenatide for type 2 diabetes: the T-emerge 2 trial.

Rosenstock et al. 2013Diabetes carecited by 93

PMID 23139373PMC3579343DOI 10.2337/dc12-0709PUB-23139373

Free to read · publisher termsCC BY-NC-ND15 results
Read at sourceSee results (15)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * adult patients, 18-75 years of age; * type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks; * HbA1c \>=7.0% and \<=10% at screening; * BMI \>=25kg/m2 (\>23kg/m2 for Asians) and \<=45kg/m2 at screening; * stable weight +/- 5% for at least 12 weeks prior to screening. Exclusion Criteria: * history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes; * history of acute metabolic diabetic complications within the previous 6 months; * evidence of clinically significant diabetic complications; * known proliferative diabetic retinopathy; * myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months; * any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator; * known hemoglobinopathy or chronic anemia; * clinically significant gastrointestinal disease.

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