Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01475734
First received: November 17, 2011
Last updated: May 29, 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, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Biological: albiglutide
Biological: 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
Eligible participants entered a 1-week Screening Period, a 2-week Run-in/Stabilization Period, a 4-day Treatment Period for the evaluation of efficacy and safety, and an 8-week post-treatment Follow-up Period. A total of 45 participants were screened, 44 were randomized, and 41 completed the study.

Reporting Groups
  Description
Albiglutide 50 mg Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
Placebo Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.

Participant Flow:   Overall Study
    Albiglutide 50 mg     Placebo  
STARTED     22     22  
COMPLETED     20     21  
NOT COMPLETED     2     1  
Withdrawal by Subject                 1                 0  
Protocol Violation                 1                 0  
Physician Decision                 0                 1  



  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
Albiglutide 50 mg Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
Placebo Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
Total Total of all reporting groups

Baseline Measures
    Albiglutide 50 mg     Placebo     Total  
Number of Participants  
[units: participants]
  22     22     44  
Age  
[units: Years]
Mean ± Standard Deviation
  49.9  ± 6.86     48.4  ± 9.32     49.1  ± 8.12  
Gender  
[units: Participants]
     
Female     12     12     24  
Male     10     10     20  
Race/Ethnicity, Customized  
[units: Participants]
     
African American/African Heritage     1     5     6  
White - Arabic/North African Heritage     0     1     1  
White - White/Caucasian/European Heritage     20     14     34  
Hispanic     0     1     1  
Mexican     1     0     1  
Persian     0     1     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Glucagon Concentration (Nanomoles Per Liter [Nmol/L]) During the Hypoglycemic Periods of the Glucose Clamp Procedure   [ Time Frame: Day 4 ]

2.  Secondary:   Insulin Secretion Rate (Measured by Mathematical Analysis of C-peptide Concentrations) During the Glucose Clamp Period   [ Time Frame: Day 4 ]

3.  Secondary:   Epinephrine Values During the Glucose Clamp Period   [ Time Frame: Day 4 ]

4.  Secondary:   Norepinephrine Values During the Glucose Clamp Period   [ Time Frame: Day 4 ]

5.  Secondary:   Growth Hormone Values During the Glucose Clamp Period   [ Time Frame: Day 4 ]

6.  Secondary:   Insulin Values During the Glucose Clamp Period   [ Time Frame: Day 4 ]

7.  Secondary:   Cortisol Values During the Glucose Clamp Period   [ Time Frame: Day 4 ]

8.  Secondary:   C-peptide Values During the Glucose Clamp Period   [ Time Frame: Day 4 ]

9.  Secondary:   Recovery Time of Plasma Glucose Levels to >=3.9 mmol/L (>=70 mg/dL) From the Hypoglycemic Clamp Level of 2.8 Nmol/L (50.4 mg/dL)   [ Time Frame: Day 4 ]

10.  Secondary:   Average Albiglutide Concentration on the Day of the Clamp Procedure   [ Time Frame: Day 4 ]

11.  Secondary:   Number of Participants With Any Treatment-emergent Serious Adverse Event (SAE) and Treatment-emergent Non-serious Adverse Event (AE) During the Clamp Period   [ Time Frame: From the time the participant consented to participate in the study through the end of the study, or the final follow-up visit for participants who discontinued active participation in the study (up to 8 study weeks) ]


  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: NCT01475734     History of Changes
Other Study ID Numbers: 108372
Study First Received: November 17, 2011
Results First Received: April 17, 2014
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration