Clinical trial NCT00318656: 24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Insulin-Dependent Diabetes Mellitus
Keywords: type 2 diabetes
rosiglitazone
metformin
glimepiride
glycemia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
timeFrame: Baseline and 12 weeks
measure: Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
timeFrame: Baseline and 12 weeks
measure: Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
timeFrame: Baseline and 12 weeks
measure: Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
timeFrame: Baseline and 12 weeks
measure: Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
timeFrame: Baseline and 12 weeks
measure: Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
timeFrame: Baseline and 12 weeks
measure: Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
timeFrame: Baseline and 12 weeks
measure: HbA1c (Glycosylated Hemoglobin)
timeFrame: Baseline and 12 weeks
measure: 8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate
timeFrame: Baseline and 12 weeks
measure: Glycaemia According to CGMS (Nocturnal), mg/dL
timeFrame: Baseline and 12 weeks
measure: Glycaemia According to CGMS (Diurnal), mg/dL
timeFrame: Baseline and 12 weeks
measure: Glycaemia According to CGMS (Dawn), mg/dL
timeFrame: Baseline and 12 weeks
measure: Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL
timeFrame: Baseline and 12 weeks
measure: Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL
timeFrame: Baseline and 12 weeks
measure: Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL
timeFrame: Baseline and 12 weeks
measure: Glycaemia According to CGMS (MAGE), mg/dL
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
citation: 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.