Rosiglitazone-Metformin Combination Versus Metformin-Sulfonylurea Combination On Beta-Cell Function In Type 2 Diabetes

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: metformin+ gliclazide

Drug: rosiglitazone-metformin

Drug: Metformin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00367055

AVAF4001

101765

Details and patient eligibility

About

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 the therapy used (diet, sulfonylureas or metformin).There is growing evidence that thiazolidinediones could have a positive action on the b-cell function. But it has not yet been demonstrated that they could protect from a deterioration in insulin secretion in the long term. So, it appears interesting to study the long term evolution of the b-cell function and the possible protection with rosiglitazone in patients with type 2 diabetes showing evidence of loss of b-cell function with metformin alone.

Enrollment

84 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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