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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01777282
Recruitment Status : Completed
First Posted : January 28, 2013
Results First Posted : October 14, 2015
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus
Interventions Drug: Albiglutide
Drug: Sulfonylurea
Drug: Biguanide
Drug: Glinide
Drug: Thiazolidinedione
Drug: Alpha-glucosidase inhibitor
Enrollment 374
Recruitment Details 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 Eligible participants entered a 2-week Screening Period; a 52-week Treatment Period and an 8-week Follow-up (FU) Period.
Arm/Group Title 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)
Hide Arm/Group Description 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. 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. 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. 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. 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.
Period Title: Overall Study
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
Reason Not Completed
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
Arm/Group Title 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
Hide Arm/Group Description 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. 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 120 67 65 61 61 374
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 67 participants 65 participants 61 participants 61 participants 374 participants
58.5  (9.19) 57.0  (8.55) 55.7  (11.07) 59.0  (10.54) 57.4  (10.47) 57.7  (9.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 67 participants 65 participants 61 participants 61 participants 374 participants
Female
33
  27.5%
22
  32.8%
22
  33.8%
11
  18.0%
20
  32.8%
108
  28.9%
Male
87
  72.5%
45
  67.2%
43
  66.2%
50
  82.0%
41
  67.2%
266
  71.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian - Japanese Heritage Number Analyzed 120 participants 67 participants 65 participants 61 participants 61 participants 374 participants
120 67 65 61 61 374
1.Primary Outcome
Title Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)
Hide Description An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. Non-serious hypoglycemia events are not included.
Time Frame From Baseline through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of study treatment.
Arm/Group Title 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)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 120 67 65 61 61
Measure Type: Number
Unit of Measure: Participants
Any AE 97 47 58 49 43
Any SAE 2 0 1 2 3
2.Primary Outcome
Title Number of Participants With Any Hypoglycemic Event
Hide Description Hypoglycemia events are defined with respect to low plasma glucose level, mostly accompanied by typical symptoms and/or assistance needed from third party with glucose administration. These events were reported by the investigators upon verification of the plasma glucose levels, symptoms and assistance recorded by the participants, and/or plasma glucose values obtained from laboratory evaluations.
Time Frame From Baseline through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of study treatment.
Arm/Group Title 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)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 120 67 65 61 61
Measure Type: Number
Unit of Measure: Participants
17 1 4 2 0
3.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52
Hide Description HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (Last Observation Carried Forward) Population: all enrolled participants who received at least 1 dose of study medication and who had at least one HbA1c post-Baseline assessment.
Arm/Group Title 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)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 120 67 65 61 60
Mean (Standard Deviation)
Unit of Measure: Percentage of HbA1c in the blood
-1.04  (0.657) -0.94  (0.623) -0.95  (0.836) -1.42  (0.771) -1.39  (0.770)
4.Secondary Outcome
Title 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)
Hide Description HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (Last Observation Carried Forward) Population
Arm/Group Title 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)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 120 67 65 61 60
Measure Type: Number
Unit of Measure: Percentage of participants
HbA1c <6.5% 20.0 26.9 24.6 45.9 26.2
HbA1c <7.0% 54.2 59.7 52.3 80.3 67.2
5.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Hide Description FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline FPG observation carried forward for the analysis.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (Last Observation Carried Forward) Population. Only those participants with valid post-Baseline results (within 14 days of last exposure to treatment) were analyzed.
Arm/Group Title 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)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 120 67 65 61 59
Mean (Standard Deviation)
Unit of Measure: Milligrams per deciliter (mg/dL)
-16.4  (28.52) -24.3  (19.98) -16.4  (30.37) -32.1  (27.21) -33.2  (28.38)
6.Secondary Outcome
Title Change From Baseline in Body Weight at Week 52
Hide Description The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline weight observation carried forward for the analysis.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (Last Observation Carried Forward) Population
Arm/Group Title 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)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 120 67 65 61 60
Mean (Standard Deviation)
Unit of Measure: Kilograms (kg)
0.25  (2.167) -0.33  (2.082) -0.04  (2.405) 0.52  (2.823) -0.13  (2.620)
7.Secondary Outcome
Title Time to Study Withdrawal Due to Hyperglycemia
Hide Description Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose >=280 mg/dL (>=15.5 mmol/L) from >=Week 2 to <Week 12 or >=230 mg/dL (>=12.8 mmol/L) from >=Week 12 to <Week 52.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (Last Observation Carried Forward) Population. Only participants who were withdrawn due to hyperglycemia were analyzed.
Arm/Group Title 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)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 1 0 2 0 0
Mean (Standard Deviation)
Unit of Measure: Weeks
13.0 [1]   (NA) 16.5  (3.54)
[1]
There were too few events to provide an estimable standard deviation.
Time Frame On-therapy non-serious adverse events (AEs) and serious adverse events (SAEs) with an onset date on or after the start date of study treatment and within 56 days after the date of the last dose of study treatment, are summarized through Week 52.
Adverse Event Reporting Description The non-serious AEs and SAEs are reported for the Safety Population, which comprised of all participants who received at least 1 dose of study treatment; par. underwent uptitration of albiglutide from 30 mg to 50 mg weekly based on glycemic parameters.
 
Arm/Group Title 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)
Hide Arm/Group Description 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. 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. 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. 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. 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.
All-Cause Mortality
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)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
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)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/120 (1.67%)   0/67 (0.00%)   1/65 (1.54%)   2/61 (3.28%)   3/61 (4.92%) 
General disorders           
Chest discomfort  0/120 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  1/61 (1.64%) 
Hepatobiliary disorders           
Cholelithiasis  0/120 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  1/61 (1.64%) 
Infections and infestations           
Anal abscess  1/120 (0.83%)  0/67 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  0/61 (0.00%) 
Urinary tract infection  1/120 (0.83%)  0/67 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  0/61 (0.00%) 
Injury, poisoning and procedural complications           
Femur fracture  0/120 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/61 (0.00%)  1/61 (1.64%) 
Foot fracture  0/120 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/61 (1.64%)  0/61 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Colon Adenoma  0/120 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/61 (0.00%)  0/61 (0.00%) 
Papillary thyroid cancer  0/120 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/61 (1.64%)  0/61 (0.00%) 
1
Term from vocabulary, MedDRA version 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   68/120 (56.67%)   31/67 (46.27%)   38/65 (58.46%)   35/61 (57.38%)   24/61 (39.34%) 
Eye disorders           
Diabetic retinopathy  8/120 (6.67%)  3/67 (4.48%)  0/65 (0.00%)  5/61 (8.20%)  4/61 (6.56%) 
Gastrointestinal disorders           
Constipation  15/120 (12.50%)  1/67 (1.49%)  4/65 (6.15%)  5/61 (8.20%)  2/61 (3.28%) 
Diarrhoea  3/120 (2.50%)  6/67 (8.96%)  1/65 (1.54%)  0/61 (0.00%)  2/61 (3.28%) 
Infections and infestations           
Nasopharyngitis  37/120 (30.83%)  19/67 (28.36%)  30/65 (46.15%)  19/61 (31.15%)  17/61 (27.87%) 
Bronchitis  4/120 (3.33%)  4/67 (5.97%)  1/65 (1.54%)  2/61 (3.28%)  3/61 (4.92%) 
Pharyngitis  4/120 (3.33%)  2/67 (2.99%)  2/65 (3.08%)  4/61 (6.56%)  2/61 (3.28%) 
Gastroenteritis  6/120 (5.00%)  1/67 (1.49%)  2/65 (3.08%)  2/61 (3.28%)  0/61 (0.00%) 
Injury, poisoning and procedural complications           
Contusion  8/120 (6.67%)  0/67 (0.00%)  1/65 (1.54%)  0/61 (0.00%)  0/61 (0.00%) 
Metabolism and nutrition disorders           
Hypoglycaemia  17/120 (14.17%)  1/67 (1.49%)  4/65 (6.15%)  2/61 (3.28%)  0/61 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain  4/120 (3.33%)  2/67 (2.99%)  1/65 (1.54%)  5/61 (8.20%)  0/61 (0.00%) 
1
Term from vocabulary, MedDRA version 17.1
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01777282     History of Changes
Other Study ID Numbers: 116170
First Submitted: January 24, 2013
First Posted: January 28, 2013
Results First Submitted: September 14, 2015
Results First Posted: October 14, 2015
Last Update Posted: May 3, 2017