NCT00299871|CompletedPhase 2

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

A 13-week Multinational, Randomized, Double-Blind, Placebo-Controlled, Dose-Response Trial Assessing the Safety, Tolerability and Efficacy of AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus

Sanofi ClinicalTrials.gov

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1 other identifier

DRI6012

Study Type

interventional

Target

542

Locations

7 countries

Sites

Timeline

RegisteredMar 2006

StartedFeb 2006

CompletionAug 2007

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

542

participants targeted

Target at P75+ for phase_2 type-2-diabetes

Timeline

Completed

Started Feb 2006

Geographic Reach

7 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

Study Start

First participant enrolled

February 1, 2006

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2006

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed

Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

1.5 years

First QC Date

March 6, 2006

Last Update Submit

January 27, 2014

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

LIXISENATIDE (AVE0010)DRUG

Eligibility Criteria

Age30 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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%.

You may not qualify if:

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.

Contact the study team to confirm eligibility.