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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study)

NCT00131664

Type 2 Diabetes Mellitus

COMPLETED PHASE3

A Clinical Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.5/1000 mg in Healthy Male Volunteers

NCT02565368

Diabetes Mellitus, Type II

COMPLETED PHASE1

A Type 2 Diabetes Study of the Longer-Term Glycemic Effect of AVANDAMET vs. Metformin

NCT00386100

Diabetes Mellitus, Type 2

COMPLETED PHASE4

AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus

NCT00241605

Diabetes Mellitus, Type 2

COMPLETED PHASE4

Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes

NCT00622284

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AVE2268

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No