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Trial · Interventional

CompletedPhase 2Registry data

Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus

NCTNCT00299871 (opens ClinicalTrials.gov in a new tab)Other idDRI6012
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
542 participants (actual)
Sponsor
Sanofi · Industry
Design
Randomized · Double masking
Countries
7 countries

United States, Brazil, Canada, Poland, Romania, Russia, Ukraine

Start
Feb 2006
Primary completion
Aug 2007
Completion
Aug 2007
First posted
7 Mar 2006 (estimated)
Last update posted
28 Jan 2014 (estimated)
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008
  1. Ph 2

    Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus

    NCT00299871

    Feb 2006 to Aug 2007

Registry summary

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

To evaluate the dose-response relationship of AVE0010 administered once daily and twice daily with chronic dosing in metformin-treated subjects with type 2 diabetes

Interventions

  • LIXISENATIDE (AVE0010)Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. HbA1c levels at baseline and endpoint (at 13 weeks).

Secondary outcomes(1)

  1. Fructosamine, fasting plasma glucose, fasting serum insulin, proinsulin, C-peptide, glucagon.

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 · 2010

12 results

Dose-dependent effects of the once-daily GLP-1 receptor agonist lixisenatide in patients with Type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled trial.

Ratner et al. 2010Diabetic medicine : a journal of the British Diabetic Associationcited by 115

PMID 20722676PMC3068287DOI 10.1111/j.1464-5491.2010.03020.xPUB-20722676

CC BY12 results
Download PDFSee results (12)

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Males, females, age 30, - 75 years, type 2 diabetes mellitus, treated with metformin ≥1.0 g/day, at a stable dose for at least 3 months, BMI 25 - 40 kg/m2, HbA1C ≥7.0% and \<9.0%. Exclusion Criteria: * Type 1 diabetes, pregnancy, lactation, women of childbearing potential, treatment with other antidiabetic agents than metformin, history of metabolic acidosis, hemoglobinopathy or hemolytic anemia, clinically significant medical abnormalities.

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