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A Study In Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00256867
Recruitment Status : Completed
First Posted : November 22, 2005
Results First Posted : March 23, 2018
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Intervention: Drug: GSK523338

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted between 17 April 2005 and 21 December 2006 at 68 centers in five countries including United States, Canada, Australia, Mexico, and the Philippines. A total of 370 participants were randomized of which 1 participant did not received study medication remaining 369 participants were included in safety population.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of the 369 participants from safety population, 12 participants received at least one dose but did not have at least one On-Therapy value for any efficacy assessment, the remaining 357 participants were included in Intent- to-Treat population.

Reporting Groups
  Description
Fixed Dose Combination (FDC) 4/40 Milligram (mg) Participants received FDC of rosiglitazone (RSG) 4.0 mg and simvastatin (SIMV) 40 mg (FDC 4/40) and matching placebo once a day for 16 weeks. In case of the participants who had Low Density Lipoprotein-cholesterol (LDL-c) > 130 milligram per deciliter (mg/dL) at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg from Week 6 till Week 16.
FDC 4/80 mg Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.
FDC 8/40 mg Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg from Week 6 till Week 16.
FDC 8/80 mg Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
RSG 4mg Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.
RSG 8mg Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.
SIMV 40mg Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.
SIMV 80mg Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.

Participant Flow:   Overall Study
    Fixed Dose Combination (FDC) 4/40 Milligram (mg)   FDC 4/80 mg   FDC 8/40 mg   FDC 8/80 mg   RSG 4mg   RSG 8mg   SIMV 40mg   SIMV 80mg
STARTED   47   44   45   46   48   46   46   47 
COMPLETED   45   39   40   40   41   40   41   36 
NOT COMPLETED   2   5   5   6   7   6   5   11 
Adverse Event                0                1                1                1                2                2                1                4 
Lost to Follow-up                2                2                2                3                2                0                1                2 
Protocol Violation                0                0                0                1                0                1                0                1 
Withdrawal by Subject                0                0                1                1                2                2                3                2 
Fasting plasma glucose more than 240                0                1                0                0                0                0                0                0 
Glycemia over 13.3                0                0                0                0                0                0                0                1 
Investigator's Decision                0                0                0                0                1                0                0                0 
Non-compliance with study medication                0                0                0                0                0                0                0                1 
Participant travelled Overseas                0                1                0                0                0                0                0                0 
Participant was out of windows                0                0                1                0                0                0                0                0 
Withdrawal by participant                0                0                0                0                0                1                0                0 



  Baseline Characteristics

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.
Safety Population comprised of all participants who were randomized and received at least one dose of study medication. No race information available for one participant in arm SIMV 40mg.

Reporting Groups
  Description
FDC RSG/SIMV 4/40 mg Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
FDC RSG/SIMV 4/80 mg Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.
FDC RSG/SIMV 8/40 mg Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
FDC RSG/SIMV 8/80 mg Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
RSG 4mg Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.
RSG 8mg Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.
SIMV 40mg Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.
SIMV 80mg Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.
Total Total of all reporting groups

Baseline Measures
   FDC RSG/SIMV 4/40 mg   FDC RSG/SIMV 4/80 mg   FDC RSG/SIMV 8/40 mg   FDC RSG/SIMV 8/80 mg   RSG 4mg   RSG 8mg   SIMV 40mg   SIMV 80mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 47   44   45   46   48   46   46   47   369 
Age 
[Units: Years]
Mean (Standard Deviation)
 55  (9.13)   55.1  (10.31)   56.9  (9.07)   55  (8.65)   53.8  (11.37)   54.6  (9.93)   53.4  (9.03)   53.5  (10.49)   54.6  (9.76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                 
Female      23  48.9%      23  52.3%      23  51.1%      22  47.8%      24  50.0%      25  54.3%      25  54.3%      25  53.2%      190  51.5% 
Male      24  51.1%      21  47.7%      22  48.9%      24  52.2%      24  50.0%      21  45.7%      21  45.7%      22  46.8%      179  48.5% 
Race/Ethnicity, Customized 
[Units: Participants]
                 
African American/African Heritage   1   0   5   6   7   3   2   2   26 
American Indian or Alaska Native   1   1   0   0   0   0   0   0   2 
Asian - Central/South Asian Heritage   1   4   4   1   4   2   3   4   23 
Asian - East Asian Heritage   0   2   0   0   1   0   0   2   5 
Asian - South East Asian Heritage   10   6   12   6   7   5   10   11   67 
Native Hawaiian or other Pacific Islander   2   1   0   0   0   0   0   0   3 
White - Arabic/North African Heritage   0   0   3   2   0   1   0   2   8 
White -White/Caucasian/European Heritage   28   23   20   30   27   27   28   20   203 
Mixed Race   4   7   1   1   2   8   2   6   31 
Missing   0   0   0   0   0   0   1   0   1 


  Outcome Measures

1.  Primary:   Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy   [ Time Frame: Baseline (Week 0) and Week 6 ]

2.  Secondary:   Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy   [ Time Frame: Baseline (Week 0) and Week 16 ]

3.  Secondary:   Median Percent Change From Baseline to Week 6 in LDL-c   [ Time Frame: Baseline (Week 0) and Week 6 ]

4.  Secondary:   Mean Change From Baseline to Week 16 in HbA1c   [ Time Frame: Baseline (Week 0) and Week 16 ]

5.  Secondary:   Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG)   [ Time Frame: Baseline (Week 0) and Week 16 ]

6.  Secondary:   Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6   [ Time Frame: Week 6 ]

7.  Secondary:   Number of Participants With HbA1c < 7.0% or Reduction of HbA1c ≥ 0.7% at Week 16   [ Time Frame: Up to Week 16 ]

8.  Secondary:   Number of Participants With FPG< 126 mg/dL (7.0 mmol/L) or Reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16   [ Time Frame: Week 16 ]

9.  Secondary:   On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate   [ Time Frame: Up to Week 16 ]

10.  Secondary:   On-Therapy Change From Baseline in Body Weight   [ Time Frame: Up to Week 16 ]

11.  Secondary:   Number of Participants With Red Blood Cells and White Blood Cells in Urine   [ Time Frame: Up to Week 16 ]

12.  Secondary:   Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)   [ Time Frame: Up to Week 16 ]

13.  Secondary:   Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline   [ Time Frame: Up to Week 16 ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00256867     History of Changes
Other Study ID Numbers: AVS101946
First Submitted: November 18, 2005
First Posted: November 22, 2005
Results First Submitted: August 24, 2017
Results First Posted: March 23, 2018
Last Update Posted: March 23, 2018