Status:
COMPLETED
Rosiglitazone-Metformin Combination Versus Metformin-Sulfonylurea Combination On Beta-Cell Function In Type 2 Diabetes
Lead Sponsor:
GlaxoSmithKline
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief Summary
It has been shown in previous study that progressive glycemic deterioration was associated with progressive loss of b-cell function, measured by the decrease in plasma insulin levels, irrespective of ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Males and females 40 to 75 years of age (inclusive at the time of screening)
- Type 2 diabetes mellitus as defined by the WHO criteria, diagnosed for at least 1 year
- Subjects receiving 1.5 to 3g of metformin alone at a constant dose for at least 8 weeks prior to visit 1
- Patients with 6.5% \< HbA1c \> 8% at visit 1 and visit 2
- 25 \< BMI \< 35
- EXCLUSION CRITERIA:
- Patient with type 1 diabetes
- Treatment with other hypoglycaemic agents than metformin in the last 3 months
- FPG \>200 mg/dL at visit 2
- Hypersensitivity to the studied treatments (rosiglitazone, metformin chlorhydrate, gliclazide)
- Congestive heart failure (NYHA class I to IV), unstable or severe angina, recent myocardial infarction
- Respiratory insufficiency
- Subjects who have required the use of insulin for glycaemic control in the past 6 months prior to visit 1 (except during pregnancy or acute episodes such as hospitalization, trauma or infection) or subjects with a history of metabolic acidosis including diabetic ketoacidosis
- Anemia defined by haemoglobin concentration \<11.0 g/dL for males and \<10.0 g/dL for females
- Renal disease or renal dysfunction, e.g. as suggested by serum creatinine levels ≥135.0 µmol/L in males and ≥110.0 µmol/L in females and/or creatinine clearance \<40 mL/min
- Presence of clinically significant hepatic disease, with ALT, AST, total bilirubin, alkaline phosphatase \>2.5 times the upper limit of the normal reference range
- Subjects with chronic diseases requiring periodic ot intermittent treatment with oral or IV corticosteroids
- Subjects receiving danazol, miconazole or phenylbutazone
- Active alcohol, drug or medication abuse within the last 6 months or any condition that would indicate the likelihood of poor subject compliance
- Women who are lactating, pregnant or planning to become pregnant
- Any clinically significant abnormality identified at screening which, in the investigator's judgement, makes the subject unsuitable for inclusion in the study
- Use of any other investigational agent within 30 days or 5 half-lives (whichever is longer) prior to visit 1
- Subjects who receive or anticipate receiving radiocontrast dye during the study
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00367055
Start Date
October 1 2004
End Date
October 1 2008
Last Update
July 27 2010
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