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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 on August 21, 2006.   Last Updated on July 20, 2010   History of Changes
Results First Received: October 2, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: rosiglitazone-metformin
Drug: Metformin
Drug: metformin+ gliclazide

  Participant Flow
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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 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months

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 too 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 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months

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  
Body Mass Index (BMI) [1]
[units: kilograms per square meter (kg/m2)]
 		     
<25     3     0     3  
25-30     21     20     41  
>30     19     21     40  
FBG [2]
[units: Millimoles/Liter (mmol/L)]
Mean ± Standard Deviation 		  9.10  ± 1.72     8.28  ± 1.11     8.70  ± 1.50  
HbA1c [3]
[units: percentage]
Mean ± Standard Deviation 		  7.5  ± 0.55     7.3  ± 0.55     7.4  ± 0.57  
[1] Number of participants with the indicated class of BMI at randomization
[2] Mean fasting blood glucose (FBG) levels were measured by blood draw
[3] 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   [ Time Frame: Baseline and Month 36 ]
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2.  Secondary:   Median Change From Baseline in the Insulin Secretion Capacity After an 18-month Treatment   [ Time Frame: Baseline and Month 18 ]
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3.  Secondary:   Mean Change From Baseline in HbA1c at Month 36   [ Time Frame: Baseline and Month 36 ]
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4.  Secondary:   Mean Change From Baseline in FBG at Month 36   [ Time Frame: Baseline and Month 36 ]
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5.  Secondary:   Mean Change From Baseline in Insulin Sensitivity Index at Months 18 and 36   [ Time Frame: Baseline and Months 18 and 36 ]
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6.  Secondary:   Median Change From Baseline in the Ratio M/I After a 36-month Treatment   [ Time Frame: Baseline and Month 36 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Median Change From Baseline in Insulin Resistance Index (HOMA-IR) After a 36-month Treatment   [ Time Frame: Baseline and Month 36 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Median Change From Baseline in Beta Cell Function Index (HOMA-beta) After a 36-month Treatment   [ Time Frame: Baseline and Month 36 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Mean Change From Baseline in CPP Total and Incremental AUC T0-T30 After a 36-month Treatment   [ Time Frame: Baseline and Month 36 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Mean Change From Baseline in CPP Concentration Peak and Incremental Concentration Peak T0-T30 After a 36-month Treatment   [ Time Frame: Baseline and Month 36 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  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:
unchecked 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.
unchecked 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.


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: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00367055     History of Changes
Other Study ID Numbers: 101765, AVAF4001
Study First Received: August 21, 2006
Results First Received: October 2, 2009
Last Updated: July 20, 2010
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences





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