Trial Outcomes & Findings for 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 (NCT NCT01777282)
NCT ID: NCT01777282
Last Updated: 2017-05-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
374 participants
Primary outcome timeframe
From Baseline through Week 52
Results posted on
2017-05-03
Participant Flow
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.
Eligible participants entered a 2-week Screening Period; a 52-week Treatment Period and an 8-week Follow-up (FU) Period.
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
120
|
67
|
65
|
61
|
61
|
|
Overall Study
Completing Treatment Period
|
109
|
63
|
59
|
59
|
54
|
|
Overall Study
Completing Follow-up Period
|
109
|
63
|
59
|
59
|
54
|
|
Overall Study
COMPLETED
|
109
|
63
|
59
|
59
|
54
|
|
Overall Study
NOT COMPLETED
|
11
|
4
|
6
|
2
|
7
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|---|
|
Overall Study
Persistent Hyperglycemia
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
New Antidiabetic Medication
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
4
|
4
|
2
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
0
|
1
|
2
|
|
Overall Study
Protocol Violation
|
2
|
0
|
1
|
0
|
2
|
|
Overall Study
Moved, transfer abroad, did not enter FU
|
1
|
0
|
1
|
0
|
0
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Albiglutide Plus (+) Background OAD (Sulfonylurea)
n=120 Participants
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)
n=67 Participants
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)
n=65 Participants
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)
n=61 Participants
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)
n=61 Participants
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
n=374 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.5 Years
STANDARD_DEVIATION 9.19 • n=5 Participants
|
57.0 Years
STANDARD_DEVIATION 8.55 • n=7 Participants
|
55.7 Years
STANDARD_DEVIATION 11.07 • n=5 Participants
|
59.0 Years
STANDARD_DEVIATION 10.54 • n=4 Participants
|
57.4 Years
STANDARD_DEVIATION 10.47 • n=21 Participants
|
57.7 Years
STANDARD_DEVIATION 9.89 • n=10 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
108 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
266 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
120 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
374 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From Baseline through Week 52Population: Safety Population: all participants who received at least 1 dose of study treatment.
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.
Outcome measures
| Measure |
Albiglutide Plus (+) Background OAD (Sulfonylurea)
n=120 Participants
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)
n=67 Participants
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)
n=65 Participants
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)
n=61 Participants
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)
n=61 Participants
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.
|
|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)
Any AE
|
97 Participants
|
47 Participants
|
58 Participants
|
49 Participants
|
43 Participants
|
|
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)
Any SAE
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From Baseline through Week 52Population: Safety Population: all participants who received at least 1 dose of study treatment.
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.
Outcome measures
| Measure |
Albiglutide Plus (+) Background OAD (Sulfonylurea)
n=120 Participants
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)
n=67 Participants
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)
n=65 Participants
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)
n=61 Participants
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)
n=61 Participants
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.
|
|---|---|---|---|---|---|
|
Number of Participants With Any Hypoglycemic Event
|
17 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: 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.
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.
Outcome measures
| Measure |
Albiglutide Plus (+) Background OAD (Sulfonylurea)
n=120 Participants
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)
n=67 Participants
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)
n=65 Participants
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)
n=61 Participants
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)
n=60 Participants
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.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52
|
-1.04 Percentage of HbA1c in the blood
Standard Deviation 0.657
|
-0.94 Percentage of HbA1c in the blood
Standard Deviation 0.623
|
-0.95 Percentage of HbA1c in the blood
Standard Deviation 0.836
|
-1.42 Percentage of HbA1c in the blood
Standard Deviation 0.771
|
-1.39 Percentage of HbA1c in the blood
Standard Deviation 0.770
|
SECONDARY outcome
Timeframe: Week 52Population: Intent-to-Treat (Last Observation Carried Forward) Population
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%.
Outcome measures
| Measure |
Albiglutide Plus (+) Background OAD (Sulfonylurea)
n=120 Participants
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)
n=67 Participants
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)
n=65 Participants
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)
n=61 Participants
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)
n=60 Participants
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.
|
|---|---|---|---|---|---|
|
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)
HbA1c <6.5%
|
20.0 Percentage of participants
|
26.9 Percentage of participants
|
24.6 Percentage of participants
|
45.9 Percentage of participants
|
26.2 Percentage of participants
|
|
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)
HbA1c <7.0%
|
54.2 Percentage of participants
|
59.7 Percentage of participants
|
52.3 Percentage of participants
|
80.3 Percentage of participants
|
67.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: 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.
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.
Outcome measures
| Measure |
Albiglutide Plus (+) Background OAD (Sulfonylurea)
n=120 Participants
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)
n=67 Participants
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)
n=65 Participants
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)
n=61 Participants
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)
n=59 Participants
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.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
|
-16.4 Milligrams per deciliter (mg/dL)
Standard Deviation 28.52
|
-24.3 Milligrams per deciliter (mg/dL)
Standard Deviation 19.98
|
-16.4 Milligrams per deciliter (mg/dL)
Standard Deviation 30.37
|
-32.1 Milligrams per deciliter (mg/dL)
Standard Deviation 27.21
|
-33.2 Milligrams per deciliter (mg/dL)
Standard Deviation 28.38
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Intent-to-Treat (Last Observation Carried Forward) Population
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.
Outcome measures
| Measure |
Albiglutide Plus (+) Background OAD (Sulfonylurea)
n=120 Participants
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)
n=67 Participants
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)
n=65 Participants
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)
n=61 Participants
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)
n=60 Participants
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.
|
|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 52
|
0.25 Kilograms (kg)
Standard Deviation 2.167
|
-0.33 Kilograms (kg)
Standard Deviation 2.082
|
-0.04 Kilograms (kg)
Standard Deviation 2.405
|
0.52 Kilograms (kg)
Standard Deviation 2.823
|
-0.13 Kilograms (kg)
Standard Deviation 2.620
|
SECONDARY outcome
Timeframe: Week 52Population: Intent-to-Treat (Last Observation Carried Forward) Population. Only participants who were withdrawn due to hyperglycemia were analyzed.
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.
Outcome measures
| Measure |
Albiglutide Plus (+) Background OAD (Sulfonylurea)
n=1 Participants
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)
n=2 Participants
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.
|
|---|---|---|---|---|---|
|
Time to Study Withdrawal Due to Hyperglycemia
|
13.0 Weeks
Standard Deviation NA
There were too few events to provide an estimable standard deviation.
|
—
|
16.5 Weeks
Standard Deviation 3.54
|
—
|
—
|
Adverse Events
Albiglutide Plus (+) Background OAD (Sulfonylurea)
Serious events: 2 serious events
Other events: 68 other events
Deaths: 0 deaths
Albiglutide Plus (+) Background OAD (Biguanide)
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Albiglutide Plus (+) Background OAD (Glinide)
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
Albiglutide Plus (+) Background OAD (Thiazolidinedione)
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Albiglutide Plus (+) Background OAD (Sulfonylurea)
n=120 participants at risk
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)
n=67 participants at risk
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)
n=65 participants at risk
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)
n=61 participants at risk
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)
n=61 participants at risk
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.
|
|---|---|---|---|---|---|
|
Infections and infestations
Anal abscess
|
0.83%
1/120 • 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.
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.
|
0.00%
0/67 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.00%
0/61 • 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.
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.
|
0.00%
0/61 • 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.
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.
|
|
Infections and infestations
Urinary tract infection
|
0.83%
1/120 • 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.
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.
|
0.00%
0/67 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.00%
0/61 • 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.
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.
|
0.00%
0/61 • 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.
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.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/120 • 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.
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.
|
0.00%
0/67 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.00%
0/61 • 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.
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.
|
1.6%
1/61 • 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.
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.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/120 • 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.
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.
|
0.00%
0/67 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
1.6%
1/61 • 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.
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.
|
0.00%
0/61 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
|
0.00%
0/120 • 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.
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.
|
0.00%
0/67 • 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.
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.
|
1.5%
1/65 • 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.
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.
|
0.00%
0/61 • 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.
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.
|
0.00%
0/61 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/120 • 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.
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.
|
0.00%
0/67 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
1.6%
1/61 • 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.
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.
|
0.00%
0/61 • 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.
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.
|
|
General disorders
Chest discomfort
|
0.00%
0/120 • 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.
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.
|
0.00%
0/67 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.00%
0/61 • 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.
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.
|
1.6%
1/61 • 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.
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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/120 • 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.
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.
|
0.00%
0/67 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
0.00%
0/61 • 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.
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.
|
1.6%
1/61 • 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.
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.
|
Other adverse events
| Measure |
Albiglutide Plus (+) Background OAD (Sulfonylurea)
n=120 participants at risk
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)
n=67 participants at risk
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)
n=65 participants at risk
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)
n=61 participants at risk
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)
n=61 participants at risk
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.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
30.8%
37/120 • 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.
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.
|
28.4%
19/67 • 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.
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.
|
46.2%
30/65 • 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.
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.
|
31.1%
19/61 • 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.
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.
|
27.9%
17/61 • 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.
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.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
15/120 • 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.
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.
|
1.5%
1/67 • 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.
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.
|
6.2%
4/65 • 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.
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.
|
8.2%
5/61 • 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.
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.
|
3.3%
2/61 • 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.
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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
14.2%
17/120 • 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.
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.
|
1.5%
1/67 • 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.
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.
|
6.2%
4/65 • 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.
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.
|
3.3%
2/61 • 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.
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.
|
0.00%
0/61 • 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.
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.
|
|
Eye disorders
Diabetic retinopathy
|
6.7%
8/120 • 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.
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.
|
4.5%
3/67 • 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.
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.
|
0.00%
0/65 • 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.
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.
|
8.2%
5/61 • 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.
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.
|
6.6%
4/61 • 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.
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.
|
|
Infections and infestations
Bronchitis
|
3.3%
4/120 • 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.
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.
|
6.0%
4/67 • 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.
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.
|
1.5%
1/65 • 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.
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.
|
3.3%
2/61 • 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.
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.
|
4.9%
3/61 • 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.
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.
|
|
Infections and infestations
Pharyngitis
|
3.3%
4/120 • 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.
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.
|
3.0%
2/67 • 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.
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.
|
3.1%
2/65 • 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.
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.
|
6.6%
4/61 • 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.
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.
|
3.3%
2/61 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
4/120 • 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.
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.
|
3.0%
2/67 • 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.
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.
|
1.5%
1/65 • 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.
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.
|
8.2%
5/61 • 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.
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.
|
0.00%
0/61 • 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.
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
3/120 • 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.
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.
|
9.0%
6/67 • 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.
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.
|
1.5%
1/65 • 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.
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.
|
0.00%
0/61 • 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.
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.
|
3.3%
2/61 • 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.
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.
|
|
Infections and infestations
Gastroenteritis
|
5.0%
6/120 • 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.
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.
|
1.5%
1/67 • 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.
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.
|
3.1%
2/65 • 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.
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.
|
3.3%
2/61 • 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.
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.
|
0.00%
0/61 • 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.
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
8/120 • 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.
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.
|
0.00%
0/67 • 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.
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.
|
1.5%
1/65 • 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.
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.
|
0.00%
0/61 • 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.
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.
|
0.00%
0/61 • 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.
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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER