Dose-Ranging Study Evaluating AVE2268 in Patients With Type 2 Diabetes Not Adequately Controlled by a Metformin Treatment
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00361738
First received: August 7, 2006
Last updated: February 6, 2009
Last verified: February 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: AVE2268 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Change in Mean Plasma Glucose (MPG) from baseline to week 4.
Secondary Outcome Measures:
- 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
| Enrollment: | 317 |
| Study Start Date: | July 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361738
Locations
| Argentina | |
| Sanofi-Aventis Administrative Office | |
| San Isidro, Argentina | |
| Australia, New South Wales | |
| Sanofi-Aventis Administrative Office | |
| Cove, New South Wales, Australia | |
| Belgium | |
| Sanofi-Aventis Administrative Office | |
| Diegem, Belgium | |
| Chile | |
| Sanofi-Aventis Administrative Office | |
| Santiago, Chile | |
| Denmark | |
| Sanofi-Aventis Administrative Office | |
| Horsholm, Denmark | |
| France | |
| Sanofi-Aventis Administrative Office | |
| Paris, France | |
| Germany | |
| Sanofi-Aventis Administrative Office | |
| Berlin, Germany | |
| Italy | |
| Sanofi-Aventis Administrative Office | |
| Milano, Italy | |
| Netherlands | |
| Sanofi-Aventis Administrative Office | |
| Gouda, Netherlands | |
| Poland | |
| Sanofi-Aventis Administrative Office | |
| Warszawa, Poland | |
| South Africa | |
| Sanofi-Aventis Administrative Office | |
| Midrand, South Africa | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Elisabeth SOUHAMI, M.D | Sanofi |
More Information
Additional Information:
No publications provided
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00361738 History of Changes |
| Other Study ID Numbers: | DRI6738, EUDRACT: 2006-001843-74 |
| Study First Received: | August 7, 2006 |
| Last Updated: | February 6, 2009 |
| Health Authority: | South Africa: Medicines Control Council Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Germany: Ethics Commission |
Keywords provided by Sanofi:
|
Type 2 Diabetes Mellitus |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013