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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00318656
First received: April 25, 2006
Last updated: April 10, 2009
Last verified: April 2009
History of Changes
  Purpose

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).


Condition Intervention Phase
Non-Insulin-Dependent Diabetes Mellitus
 Drug: rosiglitazone-metformin fixed dose combination
Drug: metformin + glimepiride
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • HbA1c (Glycosylated Hemoglobin) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • 8-Iso Prostaglandin F2α (8-Iso PGF2α) Excretion Rate [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Glycaemia According to CGMS (Nocturnal), mg/dL [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Glycaemia According to CGMS (Diurnal), mg/dL [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Glycaemia According to CGMS (Dawn), mg/dL [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Glycaemia According to CGMS (MAGE), mg/dL [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: November 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: rosiglitazone-metformin fixed dose combination Drug: metformin + glimepiride
    Other Names:
    • rosiglitazone-metformin fixed dose combination
    • metformin + glimepiride
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318656

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00318656     History of Changes
Other Study ID Numbers: 104988, AVAF4003
Study First Received: April 25, 2006
Results First Received: October 17, 2008
Last Updated: April 10, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by GlaxoSmithKline:
type 2 diabetes
rosiglitazone
metformin
glimepiride
glycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Rosiglitazone
Metformin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013