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

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

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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

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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

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

Other Adverse Events

	Rosiglitazone + Metformin 4 mg/2 g/Day	Gliclazide + Metformin 80 mg/2 g/Day
Total, other (not including serious) adverse events
# participants affected / at risk	31	29
Ear and labyrinth disorders
Vertigo ^†^A # participants affected / at risk	1/43 (2.33%)	3/41 (7.32%)
Gastrointestinal disorders
Diarrhea ^†^A # participants affected / at risk	3/43 (6.98%)	3/41 (7.32%)
Constipation ^†^A # participants affected / at risk	2/43 (4.65%)	1/41 (2.44%)
Sigmoiditis ^†^A # participants affected / at risk	2/43 (4.65%)	1/41 (2.44%)
Colopathy ^†^A # participants affected / at risk	2/43 (4.65%)	0/41 (0.00%)
Nausea ^†^A # participants affected / at risk	2/43 (4.65%)	0/41 (0.00%)
Abdominal pain ^†^A # participants affected / at risk	1/43 (2.33%)	2/41 (4.88%)
Infections and infestations
Tonsilitis ^†^A # participants affected / at risk	1/43 (2.33%)	2/41 (4.88%)
Fungal infection ^†^A # participants affected / at risk	0/43 (0.00%)	3/41 (7.32%)
Rhinitis ^†^A # participants affected / at risk	0/43 (0.00%)	3/41 (7.32%)
Orchitis ^†^A # participants affected / at risk	0/43 (0.00%)	2/41 (4.88%)
Metabolism and nutrition disorders
Hypoglycemia ^†^A # participants affected / at risk	1/43 (2.33%)	8/41 (19.51%)
Hyperglycemia ^†^A # participants affected / at risk	1/43 (2.33%)	2/41 (4.88%)
Musculoskeletal and connective tissue disorders
Lumbago ^†^A # participants affected / at risk	4/43 (9.30%)	1/41 (2.44%)
Lumbar pain ^†^A # participants affected / at risk	3/43 (6.98%)	2/41 (4.88%)
Knee pain ^†^A # participants affected / at risk	2/43 (4.65%)	3/41 (7.32%)
Gonalgia ^†^A # participants affected / at risk	2/43 (4.65%)	2/41 (4.88%)
Gonarthrosis ^†^A # participants affected / at risk	2/43 (4.65%)	1/41 (2.44%)
Tendonitis ^†^A # participants affected / at risk	1/43 (2.33%)	4/41 (9.76%)
Nervous system disorders
Carpal tunnel syndrome ^†^A # participants affected / at risk	1/43 (2.33%)	4/41 (9.76%)
Sciatica ^†^A # participants affected / at risk	3/43 (6.98%)	2/41 (4.88%)
Headache ^†^A # participants affected / at risk	3/43 (6.98%)	1/41 (2.44%)
Formication ^†^A # participants affected / at risk	0/43 (0.00%)	2/41 (4.88%)
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis ^†^A # participants affected / at risk	9/43 (20.93%)	3/41 (7.32%)
Bronchitis ^†^A # participants affected / at risk	8/43 (18.60%)	1/41 (2.44%)
Cough ^†^A # participants affected / at risk	3/43 (6.98%)	0/41 (0.00%)
Common cold ^†^A # participants affected / at risk	2/43 (4.65%)	0/41 (0.00%)
Pharyngitis ^†^A # participants affected / at risk	2/43 (4.65%)	2/41 (4.88%)
Sinusitis ^†^A # participants affected / at risk	2/43 (4.65%)	0/41 (0.00%)
Pulmonary embolism ^†^A # participants affected / at risk	0/43 (0.00%)	2/41 (4.88%)
Skin and subcutaneous tissue disorders
Eczema ^†^A # participants affected / at risk	0/43 (0.00%)	2/41 (4.88%)

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	101765, AVAF4001
Study First Received:	August 21, 2006
Results First Received:	October 2, 2009
Last Updated:	October 2, 2009
ClinicalTrials.gov Identifier:	NCT00367055 History of Changes
Health Authority:	France: National Consultative Ethics Committee for Health and Life Sciences