Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01357850
First received: November 11, 2010
Last updated: September 29, 2014
Last verified: September 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, Caregiver, Investigator);   Primary Purpose: Basic Science
Condition: Heart Failure, Congestive
Interventions: Drug: GSK716155
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants (par.) who met eligibility criteria and completed a 30 day Screening were then randomized to a 13-week Treatment Period, followed by a Follow-up visit 28 days post-treatment. The duration of the study was approximately 20 weeks from Screening to Follow-up. A total of 100 par. were planned, and 82 par. were randomized.

Reporting Groups
  Description
Placebo Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Albiglutide 3.75 mg Participants received albiglutide 3.75 milligrams (mg) weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Albiglutide 15 mg Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Albiglutide 30 mg Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.

Participant Flow:   Overall Study
    Placebo     Albiglutide 3.75 mg     Albiglutide 15 mg     Albiglutide 30 mg  
STARTED     30     12     13     27  
COMPLETED     29     12     13     27  
NOT COMPLETED     1     0     0     0  
Lost to Follow-up                 1                 0                 0                 0  



  Baseline Characteristics
  Hide 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 albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Albiglutide 3.75 mg Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Albiglutide 15 mg Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Albiglutide 30 mg Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
Total Total of all reporting groups

Baseline Measures
    Placebo     Albiglutide 3.75 mg     Albiglutide 15 mg     Albiglutide 30 mg     Total  
Number of Participants  
[units: participants]
  30     12     13     27     82  
Age  
[units: Years]
Mean ± Standard Deviation
  55.6  ± 9.60     51.3  ± 12.44     57.2  ± 11.02     58.2  ± 10.23     56.1  ± 10.53  
Gender  
[units: Participants]
         
Female     9     3     2     7     21  
Male     21     9     11     20     61  
Race/Ethnicity, Customized  
[units: Participants]
         
African American/African Heritage     3     4     5     4     16  
Native Hawaiian Or Other Pacific Islander     1     0     0     0     1  
Asian - Central/South Asian Heritage     0     0     0     1     1  
White - White/Caucasian/European Heritage     26     7     8     22     63  
White - Arabic/North African Heritage     0     1     0     0     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Myocardial Glucose Utilization as Assessed by [18F]Fluoro-2-deoxy-glucose Positron Emission Tomography (FDG-PET) Imaging   [ Time Frame: Baseline and Week 13 ]

2.  Primary:   Change From Baseline in Myocardial Efficiency (Work Performed/Myocardial Oxygen Consumption [MVO2]) Assessed at Rest   [ Time Frame: Baseline and Week 13 ]

3.  Primary:   Change From Baseline in Peak Oxygen Uptake (Peak VO2) as Assessed by Bicycle Cardiopulmonary Exercise Testing   [ Time Frame: Baseline and Week 13 ]

4.  Secondary:   Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Assessed by Echocardiogram   [ Time Frame: Baseline and Week 13 ]

5.  Secondary:   Change From Baseline in Left Ventricular (LV) Volumes in Systole and Diastole as Assessed by Echocardiogram   [ Time Frame: Baseline and Week 13 ]

6.  Secondary:   Change From Baseline in LV and RV Function Assessed by Cardiac Magnetic Resonance (CMR) (LVEF), Myocardial Strain Assessed by Myocardial Tagging Indices   [ Time Frame: Baseline and Week 13 ]

7.  Secondary:   Change From Baseline in LV and RV Function Assessed by CMR (LV and RV Volumes in Systole and Diastole), Myocardial Strain Assessed by Myocardial Tagging Indices   [ Time Frame: Baseline and Week 13 ]

8.  Secondary:   Change From Baseline in LV and RV Function Assessed by CMR (LV Mass), Myocardial Strain Assessed by Myocardial Tagging Indices   [ Time Frame: Baseline and Week 13 ]

9.  Secondary:   Change From Baseline in Cardiac Energetics (PCr/ATP) Measured by 31P Magnetic Resonance Spectroscopy (MRS)   [ Time Frame: Baseline and Week 13 ]

10.  Secondary:   Change From Baseline in Cardiac and Liver Fat by Proton Spectroscopy (1H MRS)   [ Time Frame: Baseline and Week 13 ]

11.  Secondary:   Change From Baseline in Exercise Capacity Assessed by 6-minute Walk Test   [ Time Frame: Baseline and Week 13 ]

12.  Secondary:   Change From Baseline in Serum N-terminal Fragment Brain Natriuretic Peptide (NT-BNP) Level   [ Time Frame: Change from Baseline at Week 13 ]

13.  Secondary:   Change From Baseline in Plasma Levels of Glucose, and Free Fatty Acids (FFA)   [ Time Frame: Baseline and Week 13 ]

14.  Secondary:   Change From Baseline in Plasma Levels of Insulin   [ Time Frame: Baseline and Week 13 ]

15.  Secondary:   Change From Baseline in Quality of Life as Assessed by the Minnesota Living With Heart Failure Questionnaire   [ Time Frame: Baseline and Week 13 ]

16.  Secondary:   Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline and Week 13 ]

17.  Secondary:   Number of Participants With Adverse Events by the Indicated Severity   [ Time Frame: Baseline and Week 13 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01357850     History of Changes
Other Study ID Numbers: 112670
Study First Received: November 11, 2010
Results First Received: April 17, 2014
Last Updated: September 29, 2014
Health Authority: United States: Food and Drug Administration
Europe: European Medicines Agency