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A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00838916
First received: February 5, 2009
Last updated: May 22, 2014
Last verified: April 2014
Results First Received: April 17, 2014  
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, Type 2
Interventions: Biological: albiglutide
Drug: insulin glargine

  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
Participants (par.) who met eligibility criteria and completed a 4 week Run-in/Stabilization Period were then randomized to a 156-week Treatment Period, followed by 8 weeks of post-treatment follow-up. A total of 1060 par. were screened; 779 par. were randomized, and 745 par. received >=1 treatment dose.

Reporting Groups
  Description
Albiglutide 30 mg + Metformin +/- Sulfonylurea Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Insulin Glargine 10 Units + Metformin +/- Sulfonylurea Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.

Participant Flow for 2 periods

Period 1:   Treatment Period (156 Weeks)
    Albiglutide 30 mg + Metformin +/- Sulfonylurea   Insulin Glargine 10 Units + Metformin +/- Sulfonylurea
STARTED   504   241 
COMPLETED   308   164 
NOT COMPLETED   196   77 
Adverse Event                50                11 
Protocol Violation                12                3 
Noncompliance                21                14 
Severe or Repeated Hypoglycaemia                1                0 
Lost to Follow-up                19                18 
Withdrawal by Subject                81                29 
Physician Decision                6                1 
Termination of Study/Site by GSK                1                0 
Missing                3                1 
Pregnancy                2                0 

Period 2:   Follow-up Period (8 Weeks)
    Albiglutide 30 mg + Metformin +/- Sulfonylurea   Insulin Glargine 10 Units + Metformin +/- Sulfonylurea
STARTED   504 [1]   241 [1] 
COMPLETED   408   190 
NOT COMPLETED   96   51 
Adverse Event                10                5 
Noncompliance                6                5 
Lost to Follow-up                38                22 
Did not Enter Follow-up Period                7                7 
Withdrawn from Follow-up Participation                26                12 
Physician Decision                2                0 
Termination of Study/Site by GSK                2                0 
Withdrawal by Subject                2                0 
Missing                3                0 
[1] Participants withdrawing from the Treatment Period entered the Follow-up Period.



  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 + Metformin +/- Sulfonylurea Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Insulin Glargine 10 Units + Metformin +/- Sulfonylurea Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Total Total of all reporting groups

Baseline Measures
   Albiglutide 30 mg + Metformin +/- Sulfonylurea   Insulin Glargine 10 Units + Metformin +/- Sulfonylurea   Total 
Overall Participants Analyzed 
[Units: Participants]
 504   241   745 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.8  (9.33)   54.7  (9.75)   55.5  (9.48) 
Gender 
[Units: Participants]
     
Female   218   109   327 
Male   286   132   418 
Race/Ethnicity, Customized 
[Units: Participants]
     
African American/African Heritage   130   64   194 
American Indian or Alaskan Native   3   1   4 
Asian - Central/South Asian Heritage   7   5   12 
Asian - East Asian Heritage   2   1   3 
Asian - Japanese Heritage   0   1   1 
Asian - South East Asian Heritage   16   8   24 
Native Hawaiian or Other Pacific Islander   1   0   1 
White - Arabic/North African Heritage   7   2   9 
White - White/Caucasian/European Heritage   342   158   500 
Other - Central American Indian   1   0   1 
Other - Hispanic   0   1   1 
Other - Mexican   1   0   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52   [ Time Frame: Baseline and Week 52 ]

2.  Secondary:   Change From Baseline in HbA1c at Week 156   [ Time Frame: Baseline and Week 156 ]

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

4.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156   [ Time Frame: Baseline and Week 156 ]

5.  Secondary:   Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52   [ Time Frame: Week 52 ]

6.  Secondary:   Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156   [ Time Frame: Week 156 ]

7.  Secondary:   Time to Hyperglycemia Rescue   [ Time Frame: From the start of study medication until the end of the treatment (up to Week 156) ]

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

9.  Secondary:   Change From Baseline in Body Weight at Week 156   [ Time Frame: Baseline and Week 156 ]

10.  Secondary:   Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52   [ Time Frame: Baseline and Week 52 ]

11.  Secondary:   Albiglutide Plasma Concentrations at Week 8 and Week 24   [ Time Frame: Weeks 8 and 24 ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame On-treatment serious adverse events (SAEs) and non-serious AEs, defined as those events that had a start date on or after the first day of study medication and within 56 days after the end of study medication (up to Week 156), are reported.
Additional Description SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.

Frequency Threshold
Threshold above which other adverse events are reported   2  

Reporting Groups
  Description
Albiglutide 30 mg + Metformin +/- Sulfonylurea Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Insulin Glargine 10 Units + Metformin +/- Sulfonylurea Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.

Other Adverse Events
    Albiglutide 30 mg + Metformin +/- Sulfonylurea   Insulin Glargine 10 Units + Metformin +/- Sulfonylurea
Total, other (not including serious) adverse events     
# participants affected / at risk   429/504 (85.12%)   199/241 (82.57%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   14/504 (2.78%)   12/241 (4.98%) 
Cardiac disorders     
Palpitations † 1     
# participants affected / at risk   3/504 (0.60%)   5/241 (2.07%) 
Ear and labyrinth disorders     
Vertigo † 1     
# participants affected / at risk   11/504 (2.18%)   6/241 (2.49%) 
Eye disorders     
Cataract † 1     
# participants affected / at risk   28/504 (5.56%)   13/241 (5.39%) 
Diabetic retinopathy † 1     
# participants affected / at risk   18/504 (3.57%)   10/241 (4.15%) 
Gastrointestinal disorders     
Nausea † 1     
# participants affected / at risk   67/504 (13.29%)   18/241 (7.47%) 
Diarrhoea † 1     
# participants affected / at risk   55/504 (10.91%)   19/241 (7.88%) 
Constipation † 1     
# participants affected / at risk   29/504 (5.75%)   4/241 (1.66%) 
Vomiting † 1     
# participants affected / at risk   27/504 (5.36%)   13/241 (5.39%) 
Dyspepsia † 1     
# participants affected / at risk   21/504 (4.17%)   7/241 (2.90%) 
Gastrooesophageal reflux disease † 1     
# participants affected / at risk   15/504 (2.98%)   6/241 (2.49%) 
Abdominal pain † 1     
# participants affected / at risk   14/504 (2.78%)   8/241 (3.32%) 
Toothache † 1     
# participants affected / at risk   5/504 (0.99%)   5/241 (2.07%) 
General disorders     
Injection site reaction † 1     
# participants affected / at risk   50/504 (9.92%)   8/241 (3.32%) 
Oedema peripheral † 1     
# participants affected / at risk   30/504 (5.95%)   15/241 (6.22%) 
Injection site haematoma † 1     
# participants affected / at risk   24/504 (4.76%)   20/241 (8.30%) 
Fatigue † 1     
# participants affected / at risk   21/504 (4.17%)   3/241 (1.24%) 
Injection site erythema † 1     
# participants affected / at risk   14/504 (2.78%)   0/241 (0.00%) 
Chest pain † 1     
# participants affected / at risk   5/504 (0.99%)   8/241 (3.32%) 
Pyrexia † 1     
# participants affected / at risk   5/504 (0.99%)   7/241 (2.90%) 
Pain † 1     
# participants affected / at risk   4/504 (0.79%)   6/241 (2.49%) 
Immune system disorders     
Seasonal allergy † 1     
# participants affected / at risk   11/504 (2.18%)   6/241 (2.49%) 
Infections and infestations     
Upper respiratory tract infection † 1     
# participants affected / at risk   83/504 (16.47%)   37/241 (15.35%) 
Nasopharyngitis † 1     
# participants affected / at risk   55/504 (10.91%)   24/241 (9.96%) 
Sinusitis † 1     
# participants affected / at risk   50/504 (9.92%)   23/241 (9.54%) 
Urinary tract infection † 1     
# participants affected / at risk   47/504 (9.33%)   21/241 (8.71%) 
Bronchitis † 1     
# participants affected / at risk   44/504 (8.73%)   27/241 (11.20%) 
Influenza † 1     
# participants affected / at risk   38/504 (7.54%)   22/241 (9.13%) 
Gastroenteritis † 1     
# participants affected / at risk   19/504 (3.77%)   6/241 (2.49%) 
Cellulitis † 1     
# participants affected / at risk   15/504 (2.98%)   7/241 (2.90%) 
Pneumonia † 1     
# participants affected / at risk   12/504 (2.38%)   5/241 (2.07%) 
Onychomycosis † 1     
# participants affected / at risk   12/504 (2.38%)   2/241 (0.83%) 
Tooth abscess † 1     
# participants affected / at risk   11/504 (2.18%)   4/241 (1.66%) 
Tinea pedis † 1     
# participants affected / at risk   11/504 (2.18%)   1/241 (0.41%) 
Pharyngitis † 1     
# participants affected / at risk   10/504 (1.98%)   6/241 (2.49%) 
Cystitis † 1     
# participants affected / at risk   5/504 (0.99%)   5/241 (2.07%) 
Injury, poisoning and procedural complications     
Muscle strain † 1     
# participants affected / at risk   10/504 (1.98%)   8/241 (3.32%) 
Ligament sprain † 1     
# participants affected / at risk   10/504 (1.98%)   5/241 (2.07%) 
Contusion † 1     
# participants affected / at risk   7/504 (1.39%)   9/241 (3.73%) 
Investigations     
Weight increased † 1     
# participants affected / at risk   6/504 (1.19%)   5/241 (2.07%) 
Metabolism and nutrition disorders     
Hypoglycaemia † 1     
# participants affected / at risk   187/504 (37.10%)   117/241 (48.55%) 
Decreased appetite † 1     
# participants affected / at risk   14/504 (2.78%)   4/241 (1.66%) 
Dyslipidaemia † 1     
# participants affected / at risk   12/504 (2.38%)   7/241 (2.90%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1     
# participants affected / at risk   50/504 (9.92%)   17/241 (7.05%) 
Back pain † 1     
# participants affected / at risk   37/504 (7.34%)   20/241 (8.30%) 
Pain in extremity † 1     
# participants affected / at risk   25/504 (4.96%)   17/241 (7.05%) 
Osteoarthritis † 1     
# participants affected / at risk   21/504 (4.17%)   9/241 (3.73%) 
Muscle spasms † 1     
# participants affected / at risk   19/504 (3.77%)   6/241 (2.49%) 
Musculoskeletal pain † 1     
# participants affected / at risk   17/504 (3.37%)   19/241 (7.88%) 
Arthritis † 1     
# participants affected / at risk   11/504 (2.18%)   2/241 (0.83%) 
Myalgia † 1     
# participants affected / at risk   9/504 (1.79%)   6/241 (2.49%) 
Rotator cuff syndrome † 1     
# participants affected / at risk   4/504 (0.79%)   6/241 (2.49%) 
Spinal osteoarthritis † 1     
# participants affected / at risk   3/504 (0.60%)   5/241 (2.07%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma † 1     
# participants affected / at risk   3/504 (0.60%)   5/241 (2.07%) 
Nervous system disorders     
Headache † 1     
# participants affected / at risk   46/504 (9.13%)   20/241 (8.30%) 
Dizziness † 1     
# participants affected / at risk   30/504 (5.95%)   8/241 (3.32%) 
Diabetic neuropathy † 1     
# participants affected / at risk   26/504 (5.16%)   15/241 (6.22%) 
Carpal tunnel syndrome † 1     
# participants affected / at risk   4/504 (0.79%)   6/241 (2.49%) 
Psychiatric disorders     
Anxiety † 1     
# participants affected / at risk   22/504 (4.37%)   13/241 (5.39%) 
Depression † 1     
# participants affected / at risk   14/504 (2.78%)   7/241 (2.90%) 
Insomnia † 1     
# participants affected / at risk   13/504 (2.58%)   13/241 (5.39%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1     
# participants affected / at risk   39/504 (7.74%)   29/241 (12.03%) 
Oropharyngeal pain † 1     
# participants affected / at risk   16/504 (3.17%)   7/241 (2.90%) 
Asthma † 1     
# participants affected / at risk   12/504 (2.38%)   5/241 (2.07%) 
Nasal congestion † 1     
# participants affected / at risk   11/504 (2.18%)   1/241 (0.41%) 
Sinus congestion † 1     
# participants affected / at risk   9/504 (1.79%)   7/241 (2.90%) 
Dyspnoea † 1     
# participants affected / at risk   7/504 (1.39%)   10/241 (4.15%) 
Skin and subcutaneous tissue disorders     
Rash † 1     
# participants affected / at risk   15/504 (2.98%)   10/241 (4.15%) 
Dermatitis contact † 1     
# participants affected / at risk   9/504 (1.79%)   5/241 (2.07%) 
Hyperkeratosis † 1     
# participants affected / at risk   5/504 (0.99%)   5/241 (2.07%) 
Vascular disorders     
Hypertension † 1     
# participants affected / at risk   67/504 (13.29%)   29/241 (12.03%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA



  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
No text entered.


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00838916     History of Changes
Other Study ID Numbers: 112754
Study First Received: February 5, 2009
Results First Received: April 17, 2014
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration