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

NCT ID: NCT00318656

Last Updated: 2009-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2007-10-31

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).

Conditions

Non-Insulin-Dependent Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

rosiglitazone-metformin fixed dose combination

Intervention Type: DRUG

metformin + glimepiride

Intervention Type: DRUG

Other Intervention Names

rosiglitazone-metformin fixed dose combination

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

GSK

Principal Investigators

GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

Monnier L, Colette C, Comenducci A, Vallee D, Dejager S. Add-on therapies to metformin in type 2 diabetes: what modulates the respective decrements in postprandial and basal glucose? Diabetes Technol Ther. 2012 Oct;14(10):943-50. doi: 10.1089/dia.2012.0045. Epub 2012 Jul 9.

Reference Type: DERIVED

PMID: 22775317 (View on PubMed)

Other Identifiers

AVAF4003

Identifier Type: -

Identifier Source: secondary_id

104988

Identifier Type: -

Identifier Source: org_study_id