Trial Outcomes & Findings for A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes (NCT NCT00838916)

Last Updated: 2017-01-09

Results Overview

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 BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. Difference of least squares means (albiglutide - insulin glargine) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

779 participants

Primary outcome timeframe

Baseline and Week 52

Results posted on

2017-01-09

Participant Flow

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

Participant milestones

Participant milestones
Measure	Albiglutide 30 mg + Metformin +/- Sulfonylurea Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Insulin Glargine 10 Units + Metformin +/- Sulfonylurea Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Treatment Period (156 Weeks) STARTED	504	241
Treatment Period (156 Weeks) COMPLETED	308	164
Treatment Period (156 Weeks) NOT COMPLETED	196	77
Follow-up Period (8 Weeks) STARTED	504	241
Follow-up Period (8 Weeks) COMPLETED	408	190
Follow-up Period (8 Weeks) NOT COMPLETED	96	51

Reasons for withdrawal

Reasons for withdrawal
Measure	Albiglutide 30 mg + Metformin +/- Sulfonylurea Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Insulin Glargine 10 Units + Metformin +/- Sulfonylurea Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Treatment Period (156 Weeks) Adverse Event	50	11
Treatment Period (156 Weeks) Protocol Violation	12	3
Treatment Period (156 Weeks) Noncompliance	21	14
Treatment Period (156 Weeks) Severe or Repeated Hypoglycaemia	1	0
Treatment Period (156 Weeks) Lost to Follow-up	19	18
Treatment Period (156 Weeks) Withdrawal by Subject	81	29
Treatment Period (156 Weeks) Physician Decision	6	1
Treatment Period (156 Weeks) Termination of Study/Site by GSK	1	0
Treatment Period (156 Weeks) Missing	3	1
Treatment Period (156 Weeks) Pregnancy	2	0
Follow-up Period (8 Weeks) Adverse Event	10	5
Follow-up Period (8 Weeks) Noncompliance	6	5
Follow-up Period (8 Weeks) Lost to Follow-up	38	22
Follow-up Period (8 Weeks) Did not Enter Follow-up Period	7	7
Follow-up Period (8 Weeks) Withdrawn from Follow-up Participation	26	12
Follow-up Period (8 Weeks) Physician Decision	2	0
Follow-up Period (8 Weeks) Termination of Study/Site by GSK	2	0
Follow-up Period (8 Weeks) Withdrawal by Subject	2	0
Follow-up Period (8 Weeks) Missing	3	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Albiglutide 30 mg + Metformin +/- Sulfonylurea n=504 Participants Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Insulin Glargine 10 Units + Metformin +/- Sulfonylurea n=241 Participants Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Total n=745 Participants Total of all reporting groups
Age, Continuous	55.8 Years STANDARD_DEVIATION 9.33 • n=5 Participants	54.7 Years STANDARD_DEVIATION 9.75 • n=7 Participants	55.5 Years STANDARD_DEVIATION 9.48 • n=5 Participants
Gender Female	218 Participants n=5 Participants	109 Participants n=7 Participants	327 Participants n=5 Participants
Gender Male	286 Participants n=5 Participants	132 Participants n=7 Participants	418 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	130 Participants n=5 Participants	64 Participants n=7 Participants	194 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	342 Participants n=5 Participants	158 Participants n=7 Participants	500 Participants n=5 Participants
Race/Ethnicity, Customized Other - Central American Indian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other - Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other - Mexican	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 52

Population: Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received \>=1 dose of study medication and who had a BL assessment and \>=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg + Metformin +/- Sulfonylurea n=493 Participants Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Insulin Glargine 10 Units + Metformin +/- Sulfonylurea n=238 Participants Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52	-0.67 Percentage of HbA1c in the blood Standard Error 0.044	-0.79 Percentage of HbA1c in the blood Standard Error 0.064

SECONDARY outcome

Timeframe: Baseline and Week 156

Population: ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed.

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg + Metformin +/- Sulfonylurea n=123 Participants Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Insulin Glargine 10 Units + Metformin +/- Sulfonylurea n=88 Participants Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Change From Baseline in HbA1c at Week 156	-0.83 Percentage of HbA1c in the blood Standard Deviation 0.980	-1.00 Percentage of HbA1c in the blood Standard Deviation 0.922

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg + Metformin +/- Sulfonylurea n=494 Participants Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Insulin Glargine 10 Units + Metformin +/- Sulfonylurea n=238 Participants Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52	-0.87 Millimoles per liter (mmol/L) Standard Error 0.127	-2.06 Millimoles per liter (mmol/L) Standard Error 0.184

SECONDARY outcome

Timeframe: Baseline and Week 156

Population: ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg + Metformin +/- Sulfonylurea n=119 Participants Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Insulin Glargine 10 Units + Metformin +/- Sulfonylurea n=86 Participants Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156	-0.83 Millimoles per liter (mmol/L) Standard Deviation 2.803	-2.19 Millimoles per liter (mmol/L) Standard Deviation 3.420

SECONDARY outcome

Timeframe: Week 52

Population: ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.

The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5%, \<7%, and \<7.5% at Week 52) were assessed.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg + Metformin +/- Sulfonylurea n=493 Participants Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Insulin Glargine 10 Units + Metformin +/- Sulfonylurea n=238 Participants Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 HbA1c <7%	156 Participants	78 Participants
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 HbA1c <6.5%	54 Participants	25 Participants
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 HbA1c <7.5%	268 Participants	135 Participants

SECONDARY outcome

Timeframe: Week 156

Population: ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5%, \<7%, and \<7.5% at Week 156) were assessed.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg + Metformin +/- Sulfonylurea n=123 Participants Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Insulin Glargine 10 Units + Metformin +/- Sulfonylurea n=88 Participants Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 HbA1c <6.5%	33 Participants	18 Participants
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 HbA1c <7%	59 Participants	46 Participants
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 HbA1c <7.5%	85 Participants	71 Participants

SECONDARY outcome

Timeframe: From the start of study medication until the end of the treatment (up to Week 156)

Population: ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.

Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG \>=280 milligrams/deciliter (mg/dL) between \>=Week 2 and \<Week 4; FPG \>=250 mg/dL between \>=Week 4 and \<Week 12; HbA1c \>=8.5% and a \<=0.5% reduction from Baseline between \>=Week 12 and \<Week 24; HbA1c \>=8.5% between \>=Week 24 and \<Week 48; HbA1c \>=8.0% between \>= Week 48 and \<Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg + Metformin +/- Sulfonylurea n=496 Participants Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Insulin Glargine 10 Units + Metformin +/- Sulfonylurea n=239 Participants Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Time to Hyperglycemia Rescue	107.57 Weeks Interval 96.43 to 143.43	NA Weeks There were too few events of hyperglycemia rescue (\<50% of participants with events) to calculate the median and confidence interval.

SECONDARY outcome

Timeframe: Baseline and Week 52

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg + Metformin +/- Sulfonylurea n=495 Participants Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Insulin Glargine 10 Units + Metformin +/- Sulfonylurea n=238 Participants Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Change From Baseline in Body Weight at Week 52	-1.05 Kilograms Standard Error 0.171	1.56 Kilograms Standard Error 0.247

SECONDARY outcome

Timeframe: Baseline and Week 156

Population: ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg + Metformin +/- Sulfonylurea n=122 Participants Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Insulin Glargine 10 Units + Metformin +/- Sulfonylurea n=89 Participants Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Change From Baseline in Body Weight at Week 156	-3.47 Kilograms Standard Deviation 6.300	0.90 Kilograms Standard Deviation 4.890

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: Glucose Profile Substudy Population: all participants who participated in the 24-hour glucose profile substudy . Only those participants with a value at Baseline and Week 52 were analyzed.

A 24-hour glucose profile was collected at Baseline and Week 52 at a subset of sites in a subset of participants per treatment group using the continuous glucose monitoring device. Glucose measurements were obtained at 5 minute increments in the 24-hour period. The area under the curve (AUC) was determined using the trapezoidal method on the measurements obtained during the first 24 hours of continuous monitoring. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. The Baseline value is the last non-missing value before the start of treatment.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg + Metformin +/- Sulfonylurea n=13 Participants Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Insulin Glargine 10 Units + Metformin +/- Sulfonylurea n=9 Participants Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52	0.457 Millimoles per hour per liter (mmol.h/L) Standard Deviation 2.9898	-1.657 Millimoles per hour per liter (mmol.h/L) Standard Deviation 1.9453

SECONDARY outcome

Timeframe: Weeks 8 and 24

Population: ITT population. Only those participants with a PK sample available for analysis at the indicated time points were analyzed.

Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post-dose, Week 24 pre-dose and Week 24 post-dose. All participants receiving albiglutide were initiated on a 30 mg weekly dosing regimen; however, beginning at Week 4, uptitration of albiglutide was allowed based on glycemic response. As such, albiglutide plasma concentrations achieved at each sampling time represent a mixed population of participants receiving either 30 mg or 50 mg weekly for various durations.

Outcome measures

Outcome measures
Measure	Albiglutide 30 mg + Metformin +/- Sulfonylurea n=459 Participants Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Insulin Glargine 10 Units + Metformin +/- Sulfonylurea Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin \>=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Albiglutide Plasma Concentrations at Week 8 and Week 24 Week 8, Pre-dose, n=408	1642.83 nanograms/milliliter (ng/mL) Standard Deviation 892.570	—
Albiglutide Plasma Concentrations at Week 8 and Week 24 Week 8, Post-dose, n=398	1911.35 nanograms/milliliter (ng/mL) Standard Deviation 966.180	—
Albiglutide Plasma Concentrations at Week 8 and Week 24 Week 24, Pre-dose, n=416	2159.30 nanograms/milliliter (ng/mL) Standard Deviation 1211.714	—
Albiglutide Plasma Concentrations at Week 8 and Week 24 Week 24, Post-dose, n=401	2748.15 nanograms/milliliter (ng/mL) Standard Deviation 1503.945	—

Adverse Events

Albiglutide 30 mg + Metformin +/- Sulfonylurea

Serious events: 92 serious events

Other events: 429 other events

Deaths: 0 deaths

Insulin Glargine 10 Units + Metformin +/- Sulfonylurea

Serious events: 46 serious events

Other events: 199 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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