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A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01098539
First received: April 1, 2010
Last updated: July 24, 2014
Last verified: May 2014
Results First Received: April 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Biological: albiglutide
Drug: sitagliptin

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants entered into 2 weeks of Pre-screening and Screening; 4 weeks of Run-in/stabilization; 52-week Treatment Period for evaluation of efficacy and safety and 8 weeks of post treatment Follow-up. A total of 771 participants were screened, 507 were randomized and 495 received at least one dose of study treatment.

Reporting Groups
  Description
Albiglutide 30 mg Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
Sitagliptin 100 mg Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.

Participant Flow:   Overall Study
    Albiglutide 30 mg     Sitagliptin 100 mg  
STARTED     249     246  
COMPLETED     198     178  
NOT COMPLETED     51     68  
Adverse Event                 26                 26  
Protocol Violation                 1                 4  
Noncompliance                 3                 5  
Lost to Follow-up                 4                 4  
Withdrawal by Subject                 12                 26  
Physician Decision                 5                 3  



  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
Albiglutide 30 mg Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
Sitagliptin 100 mg Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
Total Total of all reporting groups

Baseline Measures
    Albiglutide 30 mg     Sitagliptin 100 mg     Total  
Number of Participants  
[units: participants]
  249     246     495  
Age  
[units: Years]
Mean ± Standard Deviation
  63.2  ± 8.37     63.5  ± 9.02     63.3  ± 8.69  
Gender  
[units: Participants]
     
Female     113     116     229  
Male     136     130     266  
Race/Ethnicity, Customized  
[units: Participants]
     
African American/African Heritage     36     42     78  
American Indian or Alaskan Native     16     16     32  
Asian - Central/South Asian Heritage     45     33     78  
Asian - East Asian Heritage     26     29     55  
Asian - South East Asian Heritage     13     14     27  
Native Hawaiian or Other Pacific Islander     1     0     1  
White - Arabic/North African Heritage     0     1     1  
White - White/Caucasian/European Heritage     112     111     223  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26   [ Time Frame: Baseline; Week 26 ]

2.  Secondary:   Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF   [ Time Frame: Baseline; Weeks 4, 8, 12, 16, and 20 ]

3.  Secondary:   Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases   [ Time Frame: Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52 ]

4.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26   [ Time Frame: Baseline; Week 26 ]

5.  Secondary:   Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF   [ Time Frame: Baseline; Weeks 4, 8, 12, 16, 20, and 26 ]

6.  Secondary:   Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: OC   [ Time Frame: Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52 ]

7.  Secondary:   Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF   [ Time Frame: Week 26 ]

8.  Secondary:   Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 26: LOCF   [ Time Frame: Week 26 ]

9.  Secondary:   Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC   [ Time Frame: Week 52 ]

10.  Secondary:   Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 52: OC   [ Time Frame: Week 52 ]

11.  Secondary:   Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52   [ Time Frame: Week 2 to Week 52 ]

12.  Secondary:   Time to Hyperglycemic Rescue Through Week 52   [ Time Frame: Week 2 to Week 52 ]

13.  Secondary:   Change From Baseline in Body Weight at Week 26: LOCF   [ Time Frame: Baseline; Week 26 ]

14.  Secondary:   Change From Baseline in Body Weight Through Week 26: LOCF   [ Time Frame: Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26 ]

15.  Secondary:   Change From Baseline in Body Weight Through Week 52: OC   [ Time Frame: Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 36, Week 48, and Week 52 ]

16.  Secondary:   Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16   [ Time Frame: Week 8 Pre-dose (immediately prior to dose), Week 8 Post-dose (at least 2 days after a dose of medication), Week 16 Pre-dose (immediately prior to dose), and Week 16 Post-dose (at least 2 days after previous dose of albiglutide) ]


  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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01098539     History of Changes
Other Study ID Numbers: 114130
Study First Received: April 1, 2010
Results First Received: April 17, 2014
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration