24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Non-Insulin-Dependent Diabetes Mellitus

Treatments

Drug: metformin + glimepiride

Drug: rosiglitazone-metformin fixed dose combination

Study type

Interventional

Funder types

Industry

Identifiers

NCT00318656

AVAF4003

104988

Details and patient eligibility

About

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).

Enrollment

23 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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.