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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00318656
Recruitment Status : Completed
First Posted : April 27, 2006
Results First Posted : March 18, 2009
Last Update Posted : May 7, 2009
Sponsor:
Information provided by:
GlaxoSmithKline

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).

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : November 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007



Intervention Details:
  • Drug: rosiglitazone-metformin fixed dose combination
  • Drug: metformin + glimepiride
    Other Name: rosiglitazone-metformin fixed dose combination


Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318656


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00318656    
Other Study ID Numbers: 104988
AVAF4003
First Posted: April 27, 2006    Key Record Dates
Results First Posted: March 18, 2009
Last Update Posted: May 7, 2009
Last Verified: April 2009
Keywords provided by GlaxoSmithKline:
type 2 diabetes
rosiglitazone
metformin
glimepiride
glycemia
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Glimepiride
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors