Last updated: 11/03/2018 07:53:04
24-hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Duration of hyperglycaemia (>126 mg/dL) in hours at baseline compared to after 12 weeks on treatment
Timeframe: Baseline and 12 weeks
Episodes of hyperglycaemia (>126 mg/dL) at baseline compared to after 12 weeks on treatment
Timeframe: Baseline and 12 weeks
Secondary outcomes:
Duration of severe hyperglycaemia (>150 mg/dL) in hours at baseline compared to after 12 weeks on treatment
Timeframe: Baseline and 12 weeks
Episodes of severe hyperglycaemia (>150 mg/dL) at baseline compared to after 12 weeks on treatment
Timeframe: Baseline and 12 weeks
Duration of hypoglycaemia (<80 mg/dL) in hours at baseline compared to after 12 weeks on treatment
Timeframe: Baseline and 12 weeks
Episodes of hypoglycaemia (<80 mg/dL) at baseline compared to after 12 weeks on treatment
Timeframe: Baseline and 12 weeks
Duration of hypoglycaemia (<60 mg/dL) in hours at baseline compared to after 12 weeks on treatment
Timeframe: Baseline and 12 weeks
Episodes of hypoglycaemia (<60 mg/dL) at baseline compared to after 12 weeks on treatment
Timeframe: Baseline and 12 weeks
HbA1c (glycosylated hemoglobin)
Timeframe: Baseline and 12 weeks
8-Iso Prostaglandin F2α (8-iso PGF2α) excretion rate
Timeframe: Baseline and 12 weeks
Glycaemia according to CGMS (nocturnal), mg/dL
Timeframe: Baseline and 12 weeks
Glycaemia according to CGMS (diurnal), mg/dL
Timeframe: Baseline and 12 weeks
Glycaemia according to CGMS (dawn), mg/dL
Timeframe: Baseline and 12 weeks
Glycaemia according to CGMS (Total area under the curve (AUC) for values above 1 mg/dL), mg/dL
Timeframe: Baseline and 12 weeks
Glycaemia according to CGMS (postprandial incremental AUC or values above 1 mg/dL), mg/dL
Timeframe: Baseline and 12 weeks
Glycaemia according to CGMS (basal incremental AUC or values above 1 mg/dL), mg/dL
Timeframe: Baseline and 12 weeks
Glycaemia according to CGMS (MAGE), mg/dL
Timeframe: Baseline and 12 weeks
Interventions:
Drug: rosiglitazone-metformin fixed dose combination
Drug: metformin + glimepiride
Enrollment:
23
Observational study model:
Not applicable
Primary completion date:
2007-19-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Non-Insulin-Dependent Diabetes Mellitus
Product
metformin, rosiglitazone, rosiglitazone/metformin
Collaborators
Not applicable
Study date(s)
November 2005 to October 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
40 - 80 Years
Accepts healthy volunteers
No
- Males and females aged 40 to 80 years
- Diagnosis of type 2 diabetes mellitus for at least 6 months
- 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
Inclusion and exclusion 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.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-19-10
Actual study completion date
2007-19-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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