24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | A better glycemic control is associated with less complications (cardiac diseases, blindness, etcetera) for type 2 diabetic patients. The objective is to study if rosiglitazone may lead to a more regular glycemic pattern with less hyperglycemia and hypoglycemia episodes than with a sulphonylurea (glimepiride). |
|---|---|
| Condition | Non-Insulin-Dependent Diabetes Mellitus |
| Intervention | Drug: rosiglitazone-metformin fixed dose combination Drug: metformin + glimepiride |
| Phase | Phase 4 |
| Sponsor | GlaxoSmithKline |
| Responsible Party | GlaxoSmithKline |
| ClinicalTrials.gov Identifier | NCT00318656 |
| First Received | April 25, 2006 |
| Last Updated | April 10, 2009 |
| Last verified | April 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 25, 2006 |
|---|---|
| Last Updated Date | April 10, 2009 |
| Start Date | November 2005 |
| Estimated Primary Completion Date | October 2007 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | 24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes |
|---|---|
| Official Title | Comparison of the Effects of Rosiglitazone and Glimepiride, Both Given in Combination With Metformin, on 24-Hour Glycemia in Type 2 Diabetes Patients Not Controlled With Metformin Alone. A 3-Month Multicentre, Randomized, Parallel-Group, Open-Label Study. |
| Brief Summary | A better glycemic control is associated with less complications (cardiac diseases, blindness, etcetera) for type 2 diabetic patients. The objective is to study if rosiglitazone may lead to a more regular glycemic pattern with less hyperglycemia and hypoglycemia episodes than with a sulphonylurea (glimepiride). |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Non-Insulin-Dependent Diabetes Mellitus |
| Intervention | Drug: rosiglitazone-metformin fixed dose combination Drug: metformin + glimepiride Other Names:
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| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 23 |
| Estimated Completion Date | October 2007 |
| Estimated Primary Completion Date | October 2007 |
| Eligibility Criteria | Inclusion Criteria: - Males and females aged 40 to 80 years - Diagnosis of type 2 diabetes mellitus for at least 6 months - Body mass index (BMI) ≥25kg/m2 - 7%≥HbA1c ≤ 9% at visit 2 - Treatment with metformin between 1.7g/day and 3g/day for at least 12 weeks prior to visit 1 - Female subjects must be non-pregnant, post-menopausal, surgically sterile or using effective contraceptive measures - Written informed consent Exclusion Criteria: - Use of any oral antidiabetic drug other than metformin within 12 weeks prior to screening - Significant hypersensitivity to thiazolidinediones and sulfonylureas or compounds with similar chemical structure - Subjects who have required the use of insulin for glycaemic control at any time in the past or subject with a history of metabolic acidosis including diabetic ketoacidosis - Subjects with clinically significant ongoing oedema or with a history of oedema in the 12 months prior to visit 1 - Subjects with a history of severe hypoglycaemia - Anemia defined by haemoglobin concentration <11.0g/dL for males or <10.0g/dL for females - Renal disease or renal dysfunction, e.g. as suggested by serum creatinine levels ≥135µmol/L in males and ≥110µmol/L in females - Presence of clinically significant hepatic disease (i.e. ALT, AST, total bilirubin or alkaline phosphatase >2.5 times the upper limit of the normal reference range) - Congestive heart failure (NYHA class I to IV), unstable or severe angina, recent myocardial infarction - Subjects with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids - Female who are lactating, pregnant, or planning to become pregnant - Any clinically significant abnormality identified at screening which in the judgement of the investigator makes the subject unsuitable for inclusion in the study (e.g. physical examination, laboratory test, ECG, ...) - Use of any investigational agent within 30 days or 5 half-lives (whichever is longer) prior to enrolment in this study - Active alcohol, drug or medication abuse within the last 6 months or any condition that would indicate the likelihood of poor subject compliance - Subjects not willing to comply with the procedures described in this protocol. |
| Gender | Both |
| Ages | 40 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00318656 |
|---|---|
| Other Study ID Numbers | 104988 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | GlaxoSmithKline |
| Study Sponsor | GlaxoSmithKline |
| Collaborators | Not Provided |
| Investigators | Study Director: GSK Clinical Trials, MD GlaxoSmithKline |
| Verification Date | April 2009 |