NCT00361738|CompletedPhase 2

Dose-Ranging Study Evaluating AVE2268 in Patients With Type 2 Diabetes Not Adequately Controlled by a Metformin Treatment

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Response, Multicentre, Multinational Study Evaluating the Efficacy and Safety of AVE2268 Administered Either Twice Daily (Breakfast and Lunch) at a Dose of 300, 600 and 1200 mg or Once Daily (Breakfast) at a Dose of 1200 mg, in Patients With Type 2 Diabetes Treated With Metformin and Not Adequately Controlled

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2 other identifiers

DRI6738EUDRACT: 2006-001843-74

Study Type

interventional

Target

317

Locations

11 countries

Sites

Timeline

RegisteredAug 2006

StartedJul 2006

CompletionJan 2008

Brief Summary

Dose-ranging study of AVE2268 in the management of patients with type 2 diabetes mellitus also receiving metformin. Its main objectives will be to assess the effects of several doses of AVE2268 on Mean Plasma Glucose. Its secondary objectives will be to assess the effects of AVE2268 on plasma glucose (fasting and post-prandial), and also the safety and tolerability of AVE2268.

Trial Health

On Track

Trial Health Score

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

Enrollment

317

participants targeted

Target at P75+ for phase_2 type-2-diabetes-mellitus

Timeline

Completed

Started Jul 2006

Typical duration for phase_2 type-2-diabetes-mellitus

Geographic Reach

11 countries

11 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

July 1, 2006

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

August 7, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2006

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed

Last Updated

February 9, 2009

Status Verified

February 1, 2009

Enrollment Period

1.5 years

First QC Date

August 7, 2006

Last Update Submit

February 6, 2009

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

Change in Mean Plasma Glucose (MPG) from baseline to week 4.

Secondary Outcomes (1)

Glucose parameters (change from baseline to week 4 in fasting and post prandial plasma glucose) ; Change in HbA1c and fructosamine ; Safety: physical examination, adverse events, ECG, laboratory tests

Interventions

AVE2268DRUG

Eligibility Criteria

Age18 Years - 74 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes mellitus, as defined by the American Diabetes Association, for at least one year at the time of screening.
HbA1c measured at visit 1 in the range of ≥ 7.0 and \< 9.0 %.
Stable metformin treatment (dose ≥ 1.5g/day for at least 3 months prior to enrollment in the study). No other antidiabetic medications are permitted for 3 months prior to enrollment.

You may not qualify if:

Pregnant or breast-feeding women.
Women of childbearing potential not protected by medically approved contraceptive method of birth control.
BMI \>40kg/m2
Diabetes other than type 2 diabetes.
Subjects with "brittle-diabetes" or any hospitalization or emergency room visit due to poor diabetic control within the past 6 months, previous history of diabetes related dehydration leading to hospitalization, history or evidence of ketoacidosis.
Presence or history of cancer within the past five years.
Evidence within the past 6 months of myocardial infarction, stroke, retinopathy requiring laser surgery, or heart failure requiring hospitalization.
Impaired hepatic tests, impaired renal function.
History or evidence of clinically relevant renal or urological disorder.
The investigator will evaluate whether there are other reasons why a patient may not participate.

Contact the study team to confirm eligibility.