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A Study of GSK256073 in Subjects With Type 2 Diabetes Mellitus Who Are Being Treated With Metformin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01376323
First Posted: June 20, 2011
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: August 10, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: GSK256073 1mg
Drug: GSK256073 5mg
Drug: GSK256073 10mg
Drug: GSK256073 25mg
Drug: Placebo
Drug: Sitagliptin 100mg

  Participant Flow
  Hide 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 was a study in participants with Type 2 diabetes mellitus which was conducted across 14 centers in 4 countries (France [4], Spain [3], United Kingdom [4], Unites States [3]) from 13 July 2011 to 17 September 2012. Total of 89 participants were included in the pharmacokinetic population.

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
Placebo (Pooled) Eligible participants in this arm received GSK256073 matching placebo capsules twice a day (BID) and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
GSK256073 5 mg BID Eligible participants in this arm received GSK256073 5 milligrams (mg) capsules BID orally as directed with water for 12 weeks in a fed state.
GSK256073 10 mg Once Daily Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
GSK256073 25 mg BID Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
GSK256073 50 mg Once Daily Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.

Participant Flow:   Overall Study
    Placebo (Pooled)   GSK256073 5 mg BID   GSK256073 10 mg Once Daily   GSK256073 25 mg BID   GSK256073 50 mg Once Daily
STARTED   20   18   19   19   18 
COMPLETED   18   17   16   14   17 
NOT COMPLETED   2   1   3   5   1 
Adverse Event                1                0                0                2                0 
Lost to Follow-up                0                0                0                2                0 
Physician Decision                1                0                2                1                1 
Withdrawal by Subject                0                1                1                0                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
Placebo (Pooled) Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.
GSK256073 5 mg BID Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.
GSK256073 10 mg Once Daily Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
GSK256073 25 mg BID Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.
GSK256073 50 mg Once Daily Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Total Total of all reporting groups

Baseline Measures
   Placebo (Pooled)   GSK256073 5 mg BID   GSK256073 10 mg Once Daily   GSK256073 25 mg BID   GSK256073 50 mg Once Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   18   19   19   18   94 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.0  (7.01)   60.0  (6.24)   59.6  (8.07)   60.2  (6.21)   57.1  (7.30)   58.8  (7.01) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      4  20.0%      7  38.9%      10  52.6%      5  26.3%      1   5.6%      27  28.7% 
Male      16  80.0%      11  61.1%      9  47.4%      14  73.7%      17  94.4%      67  71.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
           
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      1   5.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   1.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3  15.0%      0   0.0%      0   0.0%      2  10.5%      0   0.0%      5   5.3% 
White      16  80.0%      18 100.0%      19 100.0%      16  84.2%      18 100.0%      87  92.6% 
More than one race      0   0.0%      0   0.0%      0   0.0%      1   5.3%      0   0.0%      1   1.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)   [ Time Frame: Up to Week 12 ]

2.  Primary:   Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: Baseline (pre-dose Day 1) and up to Week 12 ]

3.  Primary:   Change From Baseline in Heart Rate   [ Time Frame: Baseline (pre-dose Day 1) and up to Week 12 ]

4.  Primary:   Number of Participants With Abnormal Electrocardiograms (ECGs) Findings   [ Time Frame: Up to Week 20 ]

5.  Primary:   Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI)   [ Time Frame: Up to Week 12 ]

6.  Primary:   Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI)   [ Time Frame: Up to Week 12 ]

7.  Primary:   Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick   [ Time Frame: Up to Week 12 ]

8.  Primary:   Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12   [ Time Frame: Baseline (Day -1) and up to Week 12 ]

9.  Secondary:   Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6   [ Time Frame: Baseline (Day 1) and up to Week 6 ]

10.  Secondary:   GSK256073 AUC and HbA1c at Week 12 Was Evaluated to Establish the Exposure-response Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship   [ Time Frame: Up to Week 12 ]

11.  Secondary:   Change From Baseline in Fasting Plasma Glucose at Week 12   [ Time Frame: Baseline (Day 1) and up to Week 12 ]

12.  Secondary:   Change From Baseline in Fasting Insulin at Week 12   [ Time Frame: Baseline (Day 1) and up to Week 12 ]

13.  Secondary:   Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12   [ Time Frame: Baseline (Day 1) and up to Week 12 ]

14.  Secondary:   Change From Baseline in Fructosamine at Week 6 and Week 12   [ Time Frame: Baseline (Day -1) and Week 12 ]

15.  Secondary:   Number of Participants With HbA1c < 7.0% and < 6.5%   [ Time Frame: Up to Week 12 ]


  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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376323     History of Changes
Other Study ID Numbers: 114728
First Submitted: June 16, 2011
First Posted: June 20, 2011
Results First Submitted: August 10, 2017
Results First Posted: October 11, 2017
Last Update Posted: October 11, 2017