Rosiglitazone-Metformin Combination Versus Metformin-Sulfonylurea Combination On Beta-Cell Function In Type 2 Diabetes

This study has been completed.

Study NCT00367055 Information provided by GlaxoSmithKline

First Received: August 21, 2006 Last Updated: October 2, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment
Condition:	Type 2 Diabetes Mellitus
Interventions:	Drug: rosiglitazone-metformin Drug: Metformin Drug: metformin+ gliclazide

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Rosiglitazone + Metformin 4 mg/2 g/Day	Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
Gliclazide + Metformin 80 mg/2 g/Day	Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 320 mg/2 g/day after 4 weeks

Participant Flow: Overall Study

	Rosiglitazone + Metformin 4 mg/2 g/Day	Gliclazide + Metformin 80 mg/2 g/Day
STARTED	43	41
COMPLETED	32	30
NOT COMPLETED	11	11
Adverse Event	6	3
Patient's Willing	3	2
Lack of Efficacy	1	2
Lost to Follow-up	1	1
Protocol Violation	0	1
Stopping Criterion Met	0	1
Participant Living oo Far from Hospital	0	1

Baseline Characteristics

Reporting Groups

	Description
Rosiglitazone + Metformin 4 mg/2 g/Day	Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
Gliclazide + Metformin 80 mg/2 g/Day	Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 320 mg/2 g/day after 4 weeks

Baseline Measures

	Rosiglitazone + Metformin 4 mg/2 g/Day	Gliclazide + Metformin 80 mg/2 g/Day	Total
Number of Participants [units: participants]	43	41	84
Age [units: years] Mean ± Standard Deviation	58.3 ± 8.4	58.1 ± 8.0	58.2 ± 8.2
Gender [units: participants]
Female	11	16	27
Male	32	25	57
Race/Ethnicity, Customized^[1] [units: participants]
Not Collected	43	41	84
Body Mass Index (BMI)^[2] [units: kilograms per square meter (kg/m2)]
<25	3	0	3
25-30	21	20	41
>30	19	21	40
FBG^[3] [units: Millimoles/Liter (mmol/L)] Mean ± Standard Deviation	9.10 ± 1.72	8.28 ± 1.11	8.70 ± 1.50
HbA1c^[4] [units: percentage] Mean ± Standard Deviation	7.5 ± 0.55	7.3 ± 0.55	7.4 ± 0.57

[1]	Region of enrollment, race, and ethnicity data were not collected in this study.
[2]	Number of participants with the indicated class of BMI at randomization
[3]	Mean fasting blood glucose (FBG) levels were measured by blood draw
[4]	Mean hemoglobin A1c (HbA1c) levels were measured by blood draw

Outcome Measures

1. Primary:

Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment [ Baseline and Month 36 ]

Show Outcome Measure 1

2. Secondary:

Median Change From Baseline in the Insulin Secretion Capacity After an 18-month Treatment [ Baseline and Month 18 ]

Show Outcome Measure 2

3. Secondary:

Mean Change From Baseline in HbA1c at Month 36 [ Baseline and Month 36 ]

Show Outcome Measure 3

4. Secondary:

Mean Change From Baseline in FBG at Month 36 [ Baseline and Month 36 ]

Show Outcome Measure 4