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Dose-Ranging Study in Treatment Naive Type 2 Diabetes Mellitus(T2DM)

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ClinicalTrials.gov Identifier: NCT00500331
Recruitment Status : Completed
First Posted : July 12, 2007
Results First Posted : December 6, 2017
Last Update Posted : December 6, 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: pioglitazone
Other: 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
This study was conducted at 121 centers of which 95 randomized participants, in 18 countries (9 European, 8 International, and the United States) from 23 January 2007 to 14 February 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Screening period was of 2 weeks. A glucose meter and detailed instructions for use were provided to all participants at the Screening visit for self- monitoring of fasting blood glucose levels and a Daily Glucose Monitoring Log for recording blood glucose information. Dietary and exercise advice was provided at randomization.

Reporting Groups
  Description
Placebo Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
GSK189075 50 mg Eligible participants received GSK189075 50 milligram (mg) tablets, orally, twice daily before breakfast and dinner for 12 weeks.
GSK189075 100 mg Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
GSK189075 250 mg Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
GSK189075 500 mg Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
GSK189075 1000 mg Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
Pioglitazone 30 mg Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.

Participant Flow:   Overall Study
    Placebo   GSK189075 50 mg   GSK189075 100 mg   GSK189075 250 mg   GSK189075 500 mg   GSK189075 1000 mg   Pioglitazone 30 mg
STARTED   48   47   48   48   48   47   48 
COMPLETED   33   42   43   38   44   42   46 
NOT COMPLETED   15   5   5   10   4   5   2 
Adverse Event                0                2                0                1                2                2                0 
Lost to Follow-up                1                1                1                2                1                0                0 
Protocol Violation                3                1                1                0                1                1                1 
Withdrawal by Subject                4                0                1                5                0                1                1 
Lack of Efficacy                3                1                0                0                0                0                0 
Liver function test abnormality                0                0                1                0                0                0                0 
Increased serum creatinine from Baseline                0                0                0                0                0                1                0 
Didn't return for continuation of study                1                0                0                0                0                0                0 
Exclusion citeria not met on Visit 4                1                0                0                0                0                0                0 
Sponsor decided to withdraw participant                1                0                0                0                0                0                0 
Participant was randomized by mistake                1                0                0                0                0                0                0 
Diabetologist nurse in the study                0                0                1                0                0                0                0 
State ban of biological samples export                0                0                0                1                0                0                0 
Protocol violated                0                0                0                1                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 Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
GSK189075 50 mg Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
GSK189075 100 mg Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
GSK189075 250 mg Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
GSK189075 500 mg Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
GSK189075 1000 mg Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
Pioglitazone 30 mg Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   GSK189075 50 mg   GSK189075 100 mg   GSK189075 250 mg   GSK189075 500 mg   GSK189075 1000 mg   Pioglitazone 30 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 48   47   48   48   48   47   48   334 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.9  (9.67)   54.3  (9.04)   56.0  (8.11)   55.7  (9.46)   54.6  (9.33)   52.4  (9.03)   54.5  (9.45)   54.8  (9.16) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
               
Female      18  37.5%      23  48.9%      17  35.4%      19  39.6%      20  41.7%      20  42.6%      24  50.0%      141  42.2% 
Male      30  62.5%      24  51.1%      31  64.6%      29  60.4%      28  58.3%      27  57.4%      24  50.0%      193  57.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
               
American Indian or Alaska Native      1   2.1%      4   8.5%      4   8.3%      3   6.3%      0   0.0%      3   6.4%      4   8.3%      19   5.7% 
Asian      1   2.1%      2   4.3%      3   6.3%      1   2.1%      2   4.2%      1   2.1%      3   6.3%      13   3.9% 
Native Hawaiian or Other Pacific Islander      1   2.1%      1   2.1%      2   4.2%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      4   1.2% 
Black or African American      0   0.0%      1   2.1%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   0.3% 
White      41  85.4%      37  78.7%      36  75.0%      41  85.4%      42  87.5%      40  85.1%      39  81.3%      276  82.6% 
More than one race      1   2.1%      0   0.0%      1   2.1%      1   2.1%      1   2.1%      1   2.1%      0   0.0%      5   1.5% 
Unknown or Not Reported      3   6.3%      2   4.3%      2   4.2%      2   4.2%      3   6.3%      2   4.3%      2   4.2%      16   4.8% 


  Outcome Measures

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

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

3.  Secondary:   Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12   [ Time Frame: Baseline (Week 0) and Week 4, Week 8 and Week 12 ]

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

5.  Secondary:   Change From Baseline to Week 12 in Fasting Insulin   [ Time Frame: Baseline (Week 0) to Week 12 ]

6.  Secondary:   Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L   [ Time Frame: Week 12 ]

7.  Secondary:   Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C])   [ Time Frame: Baseline (Week 0) and Week 4, Week 8 and Week 12 ]

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

9.  Secondary:   Change From Baseline to Week 12 in Waist Circumference   [ Time Frame: Baseline (Week 0) to Week 12 ]

10.  Secondary:   Change From Baseline in 24-hour Percent of Filtered Glucose Excreted in Urine   [ Time Frame: Baseline (Week 0) and Week 12 (24-hour urine collection) ]

11.  Secondary:   Change From Baseline in Plasma Glucose Area Under the Curve (AUC) During a 2-hour Oral Glucose Tolerance Test (OGTT)   [ Time Frame: Baseline (Week 0) and Week 12 (0 to 2 hour OGTT) ]

12.  Secondary:   Change From Baseline in Insulin AUC During a 2-hour OGTT   [ Time Frame: Baseline (Week 0) and Week 12 (0 to 2-hour OGTT) ]

13.  Secondary:   Change From Baseline in C-peptide AUC During a 2-hr OGTT   [ Time Frame: Baseline (Week 0) and Week 12 (0 to 2 hour OGTT) ]

14.  Secondary:   Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE)   [ Time Frame: Up to 12 weeks ]

15.  Secondary:   Number of Participants With On-therapy Hypoglycemia   [ Time Frame: Up to 14 weeks ]

16.  Secondary:   Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern   [ Time Frame: Up to 14 weeks ]

17.  Secondary:   Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern   [ Time Frame: Up to Early withdrawal (Between Week 12 and Week 14) ]

18.  Secondary:   Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern   [ Time Frame: Up to 14 weeks ]


  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: NCT00500331     History of Changes
Other Study ID Numbers: KG2105255
First Submitted: January 24, 2007
First Posted: July 12, 2007
Results First Submitted: September 26, 2017
Results First Posted: December 6, 2017
Last Update Posted: December 6, 2017