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Dose-Ranging Study In Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive

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ClinicalTrials.gov Identifier: NCT00495469
Recruitment Status : Completed
First Posted : July 3, 2007
Results First Posted : October 30, 2017
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: GSK189075
Drug: Placebo

  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 at 130 centers in 14 countries (9 European, 3 International countries, Canada, and the United States) during the period from 17 August 2007 to 5 June 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 822 participants with Type 2 Diabetes Mellitus who were treatment naïve, entered the 2-week screening period. Of these, 570 were screen failures. The primary reason for screening failure was the participant not meeting eligibility criteria. Out of 252 randomized participants, 250 participants received study drug.

Reporting Groups
  Description
Placebo Participants received 2 placebo tablets matching for GSK189075 twice daily (BID) before breakfast and dinner and 1 placebo capsule matching for Pioglitazone once daily (QD) before breakfast for 12 weeks
GSK189075 100 mg QD Participants received 2 tablets of GSK189075 50 milligrams (mg) each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
GSK189075 250 mg QD Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
GSK189075 500 mg QD Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
GSK189075 1000 mg QD Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
GSK189075 250 mg BID Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
Pioglitazone 30 mg QD Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.

Participant Flow:   Overall Study
    Placebo   GSK189075 100 mg QD   GSK189075 250 mg QD   GSK189075 500 mg QD   GSK189075 1000 mg QD   GSK189075 250 mg BID   Pioglitazone 30 mg QD
STARTED   36   37   34   36   36   36   35 
COMPLETED   30   30   27   32   31   31   30 
NOT COMPLETED   6   7   7   4   5   5   5 
Adverse Event                0                1                3                0                1                1                1 
Lost to Follow-up                1                1                3                1                0                0                0 
Protocol Violation                0                0                0                0                1                2                0 
Withdrawal by Subject                5                3                1                3                3                2                3 
Lack of Efficacy                0                0                0                0                0                0                1 
Liver function test abnormality                0                1                0                0                0                0                0 
ST depression at randomisation in ECG                0                1                0                0                0                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.
No text entered.

Reporting Groups
  Description
Placebo Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
GSK189075 100 mg QD Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
GSK189075 250 mg QD Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
GSK189075 500 mg QD Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
GSK189075 1000 mg QD Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
GSK189075 250 mg BID Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
Pioglitazone 30 mg QD Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   GSK189075 100 mg QD   GSK189075 250 mg QD   GSK189075 500 mg QD   GSK189075 1000 mg QD   GSK189075 250 mg BID   Pioglitazone 30 mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   37   34   36   36   36   35   250 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.6  (10.60)   53.5  (9.35)   54.4  (9.57)   52.6  (10.91)   54.5  (10.19)   50.0  (10.21)   53.2  (10.35)   52.7  (10.19) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
               
Female      20  55.6%      19  51.4%      14  41.2%      23  63.9%      13  36.1%      21  58.3%      16  45.7%      126  50.4% 
Male      16  44.4%      18  48.6%      20  58.8%      13  36.1%      23  63.9%      15  41.7%      19  54.3%      124  49.6% 
Race/Ethnicity, Customized 
[Units: Participants]
               
African American/African Heritage   2   3   3   4   2   4   1   19 
American Indian or Alaska Native   0   0   0   0   0   1   2   3 
Asian - Central/South Asian Heritage   5   7   3   2   5   5   2   29 
Asian - East Asian Heritage   1   0   0   0   0   0   0   1 
Asian - South East Asian Heritage   0   1   1   0   0   1   0   3 
White - Arabic/North African Heritage   2   1   0   0   3   1   1   8 
White - White/Caucasian/European Heritage   25   19   24   24   22   23   23   160 
Mixed Race   1   6   3   6   4   1   6   27 


  Outcome Measures

1.  Primary:   Mean Change From Baseline in Hemoglobin A1c (Glycosylated Hemoglobin) (HbA1c) at Week 12   [ Time Frame: Baseline (Week 0) and at Week 12 ]

2.  Secondary:   Mean Change From Baseline in HbA1c at Weeks 4 and 8   [ Time Frame: Baseline (Week 0) and at Week 4 nad 8 ]

3.  Secondary:   Mean Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)   [ Time Frame: Baseline (Week 0) and at Week 12 ]

4.  Secondary:   Mean Change From Baseline to Week 12 in Fructosamine (Corrected)   [ Time Frame: Baseline (Week 0) and at Week 12 ]

5.  Secondary:   Number of Participants Who Were HbA1c Responders at Week 12   [ Time Frame: Week 12 ]

6.  Secondary:   Number of Participants Who Were Fasting Plasma Glucose (FPG) Responders at Week 12   [ Time Frame: Week 12 ]

7.  Secondary:   Mean Change From Baseline to Week 12 in Triglycerides   [ Time Frame: Baseline (Week 0) and at Week 12 ]

8.  Secondary:   Mean Change From Baseline to Week 12 in Total Cholesterol   [ Time Frame: Baseline (Week 0) and at Week 12 ]

9.  Secondary:   Mean Change From Baseline to Week 12 in Low Density Lipoprotein Cholesterol (LDL-c)   [ Time Frame: Baseline (Week 0) and Week 12 ]

10.  Secondary:   Mean Change From Baseline to Week 12 in High Density Lipoprotein Cholesterol (HDL-c)   [ Time Frame: Baseline (Week 0) and Week 12 ]

11.  Secondary:   Mean Change From Baseline to Week 12 in LDL-c/HDL-c Ratio   [ Time Frame: Baseline (Week 0) and Week 12 ]

12.  Secondary:   Mean Change From Baseline to Week 12 in Total Cholesterol/HDL-c Ratio   [ Time Frame: Baseline (Week 0) and Week 12 ]

13.  Secondary:   Mean Change From Baseline to Week 12 in Body Weight   [ Time Frame: Baseline (Week 0) and Week 12 ]

14.  Secondary:   Number of Participants With Any On-therapy Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Up to Week 12 ]

15.  Secondary:   Number of Participants With On-therapy Hypoglycemia   [ Time Frame: Up to Week 12 ]

16.  Secondary:   Number of Participants With Vital Signs of Potential Clinical Importance (PCI) at Any Time on Therapy   [ Time Frame: Up to Week 12 ]

17.  Secondary:   Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline   [ Time Frame: Up to Week 12 ]

18.  Secondary:   Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy   [ Time Frame: Up to Week 12 ]

19.  Secondary:   Number of Participants With Abnormal Hematology Value of PCI at Any Time on Therapy   [ Time Frame: Up to Week 12 ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00495469     History of Changes
Other Study ID Numbers: KG2110375
First Submitted: June 29, 2007
First Posted: July 3, 2007
Results First Submitted: September 26, 2017
Results First Posted: October 30, 2017
Last Update Posted: October 30, 2017