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A Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Oral Monotherapy Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01777282
First received: January 24, 2013
Last updated: February 24, 2016
Last verified: January 2016
Results First Received: September 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus
Interventions: Drug: Albiglutide
Drug: Sulfonylurea
Drug: Biguanide
Drug: Glinide
Drug: Thiazolidinedione
Drug: Alpha-glucosidase inhibitor

  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
A total of 360 participants with type 2 diabetes mellitus (T2DM) were planned and 374 participants were enrolled and analyzed in the Safety Population; the Safety Population and Intent-to-Treat Population were identical in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants entered a 2-week Screening Period; a 52-week Treatment Period and an 8-week Follow-up (FU) Period.

Reporting Groups
  Description
Albiglutide Plus (+) Background OAD (Sulfonylurea) Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
Albiglutide Plus (+) Background OAD (Biguanide) Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
Albiglutide Plus (+) Background OAD (Glinide) Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
Albiglutide Plus (+) Background OAD (Thiazolidinedione) Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor) Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.

Participant Flow:   Overall Study
    Albiglutide Plus (+) Background OAD (Sulfonylurea)     Albiglutide Plus (+) Background OAD (Biguanide)     Albiglutide Plus (+) Background OAD (Glinide)     Albiglutide Plus (+) Background OAD (Thiazolidinedione)     Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)  
STARTED     120     67     65     61     61  
Completing Treatment Period     109     63     59     59     54  
Completing Follow-up Period     109     63     59     59     54  
COMPLETED     109     63     59     59     54  
NOT COMPLETED     11     4     6     2     7  
Persistent Hyperglycemia                 0                 0                 1                 0                 0  
New Antidiabetic Medication                 0                 0                 1                 0                 0  
Adverse Event                 4                 4                 2                 1                 3  
Withdrawal by Subject                 4                 0                 0                 1                 2  
Protocol Violation                 2                 0                 1                 0                 2  
Moved, transfer abroad, did not enter FU                 1                 0                 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
Albiglutide Plus (+) Background OAD (Sulfonylurea) Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
Albiglutide Plus (+) Background OAD (Biguanide) Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
Albiglutide Plus (+) Background OAD (Glinide) Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
Albiglutide Plus (+) Background OAD (Thiazolidinedione) Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor) Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
Total Total of all reporting groups

Baseline Measures
    Albiglutide Plus (+) Background OAD (Sulfonylurea)     Albiglutide Plus (+) Background OAD (Biguanide)     Albiglutide Plus (+) Background OAD (Glinide)     Albiglutide Plus (+) Background OAD (Thiazolidinedione)     Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)     Total  
Number of Participants  
[units: participants]
  120     67     65     61     61     374  
Age  
[units: Years]
Mean (Standard Deviation)
  58.5  (9.19)     57.0  (8.55)     55.7  (11.07)     59.0  (10.54)     57.4  (10.47)     57.7  (9.89)  
Gender  
[units: Participants]
           
Female     33     22     22     11     20     108  
Male     87     45     43     50     41     266  
Race/Ethnicity, Customized  
[units: Participants]
           
Asian - Japanese Heritage     120     67     65     61     61     374  



  Outcome Measures
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1.  Primary:   Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)   [ Time Frame: From Baseline through Week 52 ]

2.  Primary:   Number of Participants With Any Hypoglycemic Event   [ Time Frame: From Baseline through Week 52 ]

3.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52   [ Time Frame: Baseline and Week 52 ]

4.  Secondary:   Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52)   [ Time Frame: Week 52 ]

5.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52   [ Time Frame: Baseline and Week 52 ]

6.  Secondary:   Change From Baseline in Body Weight at Week 52   [ Time Frame: Baseline and Week 52 ]

7.  Secondary:   Time to Study Withdrawal Due to Hyperglycemia   [ Time Frame: Week 52 ]


  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: NCT01777282     History of Changes
Other Study ID Numbers: 116170
Study First Received: January 24, 2013
Results First Received: September 14, 2015
Last Updated: February 24, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency