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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00318656

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Glimepiride Rosiglitazone Rosiglitazone Maleate Metformin Metformin hydrochloride

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)

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

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104988, AVAF4003
Study First Received:	April 25, 2006
Results First Received:	October 17, 2008
Last Updated:	April 10, 2009
ClinicalTrials.gov Identifier:	NCT00318656 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by GlaxoSmithKline:

type 2 diabetes
rosiglitazone
metformin
glimepiride
glycemia

Additional relevant MeSH terms:

Metabolic Diseases
Immunologic Factors
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents

Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Glucose Metabolism Disorders
Rosiglitazone

ClinicalTrials.gov processed this record on February 08, 2010