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Completed

NCT Number: NCT00318656

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

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).

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Key information

Conditions

Non-Insulin-Dependent Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rosiglitazone-metformin fixed dose combination

Drug

metformin + glimepiride

Drug

Other names: rosiglitazone-metformin fixed dose combination

Primary outcomes

  1. Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment

    Time frame: Baseline and 12 weeks

    Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

  2. Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment

    Time frame: Baseline and 12 weeks

    Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

Secondary outcomes

  1. Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment

    Time frame: Baseline and 12 weeks

    Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

  2. Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment

    Time frame: Baseline and 12 weeks

    Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

  3. Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment

    Time frame: Baseline and 12 weeks

    Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

  4. Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment

    Time frame: Baseline and 12 weeks

    Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

  5. Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment

    Time frame: Baseline and 12 weeks

    Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

  6. Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment

    Time frame: Baseline and 12 weeks

    Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

  7. HbA1c (Glycosylated Hemoglobin)

    Time frame: Baseline and 12 weeks

    Uncontrolled HbA1c>8.5%. HbA1c and fasting blood glucose taken at hospital

  8. 8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate

    Time frame: Baseline and 12 weeks

    8-Iso Prostaglandin F2α (8-iso PGF2α) excretion rate measured during the 24 hours preceding the CGM system removal. The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time.

  9. Glycaemia According to CGMS (Nocturnal), mg/dL

    Time frame: Baseline and 12 weeks

    Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time.

  10. Glycaemia According to CGMS (Diurnal), mg/dL

    Time frame: Baseline and 12 weeks

    Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The diurnal glycemia measured by CGM system will be the average of glycemic values recorded between breakfast time and midnight.

  11. Glycaemia According to CGMS (Dawn), mg/dL

    Time frame: Baseline and 12 weeks

    Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The glycemia "at dawn" measured by CGM system will be defined as the average of glycemic values recorded between 4 AM and breakfast time.

  12. Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL

    Time frame: Baseline and 12 weeks

    Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.

  13. Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL

    Time frame: Baseline and 12 weeks

    Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.

  14. Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL

    Time frame: Baseline and 12 weeks

    Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.

  15. Glycaemia According to CGMS (MAGE), mg/dL

    Time frame: Baseline and 12 weeks

    Calculation of the Mean amplitude of glycemic excursion (MAGE) was obtained by measuring the arithmetic mean of the major glucose concentration increases or decreases on days 2 and 3 of glycaemic profile and then averaging results on the two days.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Apr 27, 2006
Registry last updated
May 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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