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

Non-Insulin-Dependent Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318656
• Other study ID #: 104988
• Secondary ID: AVAF4003
• Status: Completed
• Phase: Phase 4
• First received: April 25, 2006
• Last updated: April 10, 2009
• Start date: November 2005
• Est. completion date: October 2007

Study information

• Verified date: April 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Non-Insulin-Dependent Diabetes Mellitus

Intervention

Drug:
• rosiglitazone-metformin fixed dose combination

• metformin + glimepiride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment		Baseline and 12 weeks	No
Primary	Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment		Baseline and 12 weeks	No
Secondary	Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment		Baseline and 12 weeks	No
Secondary	Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment		Baseline and 12 weeks	No
Secondary	Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment		Baseline and 12 weeks	No
Secondary	Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment		Baseline and 12 weeks	No
Secondary	Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment		Baseline and 12 weeks	No
Secondary	Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment		Baseline and 12 weeks	No
Secondary	HbA1c (Glycosylated Hemoglobin)		Baseline and 12 weeks	No
Secondary	8-Iso Prostaglandin F2a (8-Iso PGF2a) Excretion Rate		Baseline and 12 weeks	No
Secondary	Glycaemia According to CGMS (Nocturnal), mg/dL		Baseline and 12 weeks	No
Secondary	Glycaemia According to CGMS (Diurnal), mg/dL		Baseline and 12 weeks	No
Secondary	Glycaemia According to CGMS (Dawn), mg/dL		Baseline and 12 weeks	No
Secondary	Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL		Baseline and 12 weeks	No
Secondary	Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL		Baseline and 12 weeks	No
Secondary	Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL		Baseline and 12 weeks	No
Secondary	Glycaemia According to CGMS (MAGE), mg/dL		Baseline and 12 weeks	No