Rosiglitazone Versus a Sulfonylurea On Progression Of Atherosclerosis In Patients With Heart Disease And Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00116831
First received: June 30, 2005
Last updated: February 7, 2013
Last verified: July 2012
Results First Received: August 7, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Non-Insulin-Dependent Diabetes Mellitus
Atherosclerosis
Cardiovascular Disease
Interventions: Drug: Glipizide
Drug: rosiglitazone maleate

  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
No text entered.

Reporting Groups
  Description
Glipizide (GLP) 5 mg Glipizide (GLP) 5 mg once daily for 18 months
Rosiglitazone (RSG) 4 mg Rosiglitazone (RSG) 4 mg once daily for 18 months

Participant Flow:   Overall Study
    Glipizide (GLP) 5 mg     Rosiglitazone (RSG) 4 mg  
STARTED     337     331  
COMPLETED     264     259  
NOT COMPLETED     73     72  
Adverse Event                 14                 16  
Baseline IVUS determined unevaluable                 12                 11  
Lost to Follow-up                 8                 6  
Protocol Violation                 3                 6  
Hypoglycaemic events                 1                 0  
Low haemoglobin on screening                 1                 0  
Withdrawn investigational product                 1                 0  
Withdrawal by Subject                 32                 32  
Insufficient therapeutic effect                 0                 1  
Missing data for participant                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Glipizide (GLP) 5 mg Glipizide (GLP) 5 mg once daily for 18 months
Rosiglitazone (RSG) 4 mg Rosiglitazone (RSG) 4 mg once daily for 18 months
Total Total of all reporting groups

Baseline Measures
    Glipizide (GLP) 5 mg     Rosiglitazone (RSG) 4 mg     Total  
Number of Participants  
[units: participants]
  337     331     668  
Age  
[units: years]
Mean ± Standard Deviation
  60.2  ± 9.05     61.8  ± 8.38     61.0  ± 8.76  
Gender  
[units: participants]
     
Female     116     98     214  
Male     221     233     454  
Race/Ethnicity, Customized  
[units: Participants]
     
White     255     240     495  
Oriental     70     82     152  
Black     7     4     11  
Mixed race     4     2     6  
Missing     0     1     1  
American Indian/Alaska native     1     2     3  
Pre-study Treatment [1]
[units: Participants]
     
Diet and exercise regimen only     64     56     120  
Oral anti-diabetic monotherapy     183     182     365  
Oral anti-diabetic dual therapy     90     93     183  
Smoking history [2]
[units: Participants]
     
Never smoked     152     151     303  
Current smoker     57     55     112  
Former smoker     128     124     252  
Missing     0     1     1  
Body Mass Index (BMI) [3]
[units: kilograms per square meter (kg/m2)]
Median ( Full Range )
  29  
  ( 19 to 52 )  
  28  
  ( 17 to 58 )  
  29  
  ( 17 to 58 )  
Duration of cardiovascular disease [4]
[units: Years]
Mean ( Full Range )
  0.79  
  ( 0.01 to 28.58 )  
  0.59  
  ( 0.00 to 25.19 )  
  0.73  
  ( 0.00 to 28 )  
Duration of diabetes [5]
[units: Years]
Median ( Full Range )
  4.62  
  ( 0 to 35.82 )  
  4.96  
  ( 0.02 to 31.66 )  
  4.74  
  ( 0 to 35.82 )  
[1] Pre-study treatment in the Safety Population
[2] Smoking history in the Safety Population
[3] Median BMI in the Safety Population
[4] Duration of cardiovascular disease in the Safety Population
[5] Duration of diabetes in the Safety Population



  Outcome Measures
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1.  Primary:   Change From Baseline in Percent Atheroma Volume (PAV) to Month 18   [ Time Frame: Baseline to Month 18 ]

2.  Primary:   Model Adjusted Change From Baseline in Percent Atheroma Volume (PAV) to Month 18   [ Time Frame: Baseline to Month 18 ]

3.  Secondary:   Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18   [ Time Frame: Baseline to Month 18 ]

4.  Secondary:   Model Adjusted Change From Baseline in Atheroma Volume to Month 18   [ Time Frame: Baseline to Month 18 ]

5.  Secondary:   Model Adjusted Change From Baseline in Lumen Volume to Month 18   [ Time Frame: Baseline to Month 18 ]

6.  Secondary:   Model Adjusted Change From Baseline in Vessel Volume to Month 18   [ Time Frame: Baseline to Month 18 ]

7.  Secondary:   Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18   [ Time Frame: Baseline to Month 18 ]

8.  Secondary:   Model Adjusted Change From Baseline in Atheroma Area to Month 18   [ Time Frame: Baseline to Month 18 ]

9.  Secondary:   Model Adjusted Change From Baseline in Lumen Area to Month 18   [ Time Frame: Baseline to Month 18 ]

10.  Secondary:   Model Adjusted Change From Baseline in Vessel Area to Month 18   [ Time Frame: Baseline to Month 18 ]

11.  Secondary:   Change From Baseline in Normalized Atheroma Volume   [ Time Frame: Baseline to Month 18 ]

12.  Secondary:   Model Adjusted Change From Baseline in Normalized Atheroma Volume   [ Time Frame: Baseline to Month 18 ]

13.  Secondary:   Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline   [ Time Frame: Baseline to Month 18 ]

14.  Secondary:   Model Adjusted Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline   [ Time Frame: Baseline to Month 18 ]

15.  Secondary:   Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline   [ Time Frame: Baseline to Month 18 ]

16.  Secondary:   Model Adjusted Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline   [ Time Frame: Baseline to Month 18 ]

17.  Secondary:   Model Adjusted Change in Glycated Hemoglobin (HbA1c) From Baseline to Month 18   [ Time Frame: Baseline to Month 18 ]

18.  Secondary:   Model Adjusted Change in Fasting Plasma Glucose (FPG) From Baseline to Month 18   [ Time Frame: Baseline to Month 18 ]

19.  Secondary:   Repeated Measures Analysis of Percent Change in hsCRP From Baseline to Month 18   [ Time Frame: Baseline to Month 18 ]

20.  Secondary:   Repeated Measures Analysis of Percent Change in MMP 9 From Baseline to Month 18   [ Time Frame: Baseline to Month 18 ]

21.  Secondary:   Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18   [ Time Frame: Baseline to Month 18 ]

22.  Secondary:   Model Adjusted Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18   [ Time Frame: Baseline to Month 18 ]

23.  Secondary:   Percent Change From Baseline to Month 18 in Total Cholesterol (TC)   [ Time Frame: Baseline to Month 18 ]

24.  Secondary:   Percent Change From Baseline to Month 18 in High Density Lipoprotein Cholesterol (HDL-c)   [ Time Frame: Baseline to Month 18 ]

25.  Secondary:   Percent Change From Baseline to Month 18 in HDL-2   [ Time Frame: Baseline to Month 18 ]

26.  Secondary:   Percent Change From Baseline to Month 18 in HDL-3   [ Time Frame: Baseline to Month 18 ]

27.  Secondary:   Percent Change From Baseline to Month 18 in Low Density Lipoprotein Cholesterol (LDL-c)   [ Time Frame: Baseline to Month 18 ]

28.  Secondary:   Percent Change From Baseline to Month 18 in Triglycerides (TG)   [ Time Frame: Baseline to Month 18 ]

29.  Secondary:   Percent Change From Baseline to Month 18 in Free Fatty Acids (FFA)   [ Time Frame: Baseline to Month 18 ]

30.  Secondary:   Percent Change From Baseline to Month 18 in Apoprotein B (apoB)   [ Time Frame: Baseline to Month 18 ]

31.  Secondary:   Change From Baseline to Month 18 in LDL-c Peak Particle Density Measured by LDL Relative Flotation   [ Time Frame: Baseline to Month 18 ]

32.  Secondary:   Change From Baseline to Month 18 in Total Cholesterol/HDL-c Ratio   [ Time Frame: Baseline to Month 18 ]

33.  Secondary:   Change From Baseline to Month 18 in LDL-c/HDL-c Ratio   [ Time Frame: Baseline to Month 18 ]

34.  Secondary:   Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for All-cause Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularization, or Hospitalization for Recurrent Myocardial Ischemia (MACE Composite 1)   [ Time Frame: Baseline to Month 21 ]

35.  Secondary:   Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for Cardiovascular Death, Nonfatal MI, or Nonfatal Stroke (MACE Composite 2)   [ Time Frame: Baseline to Month 21 ]

36.  Secondary:   Number of Other Cardiovascular Events   [ Time Frame: Baseline to Month 21 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00116831     History of Changes
Other Study ID Numbers: AVD100521
Study First Received: June 30, 2005
Results First Received: August 7, 2009
Last Updated: February 7, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada
United States: Food and Drug Administration