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
Study complete
Study complete
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:
Enrollment:
23
Primary completion date:
2007-19-10
Observational study model:
Not applicable
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)
This study does not involve prospective enrollment of participants.
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
Study complete
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website