Acceptability Study of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Type 2 Diabetes and Dyslipidemia
This study has been completed.
Sponsor:
Solvay Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00490178
First received: June 21, 2007
Last updated: August 31, 2007
Last verified: August 2007
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Purpose
The present study aims to assess the acceptability of a 4 week treatment of a new fixed-dose combination of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 Dyslipidemia |
Drug: Fenofibrate 80 mg and metformin 1000 mg (fixed combination) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label, Multicenter Trial Assessing the Acceptability of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Patients With Type 2 Diabetes and Dyslipidemia |
Resource links provided by NLM:
Further study details as provided by Solvay Pharmaceuticals:
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female patients aged from 20 to 80 years (at inclusion visit).
- Type 2 diabetes treated with a stable dose of metformin for a minimum of 3 months either alone or in combination with another oral hypoglycaemic agent.
- Dyslipidemia treated with 160 mg fenofibrate (or bioequivalent formulations) for a minimum of 3 months either alone or in combination with a statin.
- And having signed a written informed consent.-
Exclusion Criteria:
- Known Type 1 Diabetes, uncontrolled type 2 diabetes [HbA1c > 9.5 %, Fasting plasma glucose (FPG) > 240 mg/dL (> 13.4 mmol/L) on the last performed blood sample (within the last 3 months)].
- TG > 500 mg/dL (> 5.65 mmol/L) on the last performed blood sample (within the last 3 months).
- Women who are not surgically sterilized (i.e. bilateral tubal ligation, bilateral or two unilateral oophorectomies, hysterectomy) or not using adequate contraceptive methods (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide) or not postmenopausal (> 1 year since their last menstrual period).
- Pregnant or lactating women.
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00490178 History of Changes |
| Other Study ID Numbers: | C LF23-0121 06 02, 2006-002848-28 |
| Study First Received: | June 21, 2007 |
| Last Updated: | August 31, 2007 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Solvay Pharmaceuticals:
|
Type II diabetes dyslipidemia metformin fenofibrate synordia |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Lipid Metabolism Disorders Metformin Fenofibrate |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013