Trial Outcomes & Findings for Albiglutide Versus Placebo in Insulin-treated Subjects With New-onset Type 1 Diabetes Mellitus (NCT NCT02284009)

Last Updated: 2020-06-29

Results Overview

Participants (parts) had a balanced diet consistent with dietitian's advice and made no major changes in exercise regimens. Evening before the MMTT, participants had a full meal then fasted from 9 post meridiem (pm) until MMTT was completed. Water, black coffee or tea without sugar or artificial sweeteners was allowed. Plasma glucose was measured prior to the finger-stick test and MMTT was performed only if in range \> 3.9 millimoles per liter (mmol/L) \[70 mg/deciliter (dL)\] and \<= 11.1 mmol/L (200 mg/dL). Baseline was defined as the last non-missing value with assessment date on or before the 1st day of study medication. Change from Baseline was calculated by subtracting Baseline value from Week 52 value. Intent-to-treat (ITT) Population comprised of all randomly assigned participants who received at least 1 dose of study medication with at least 1 post-Baseline assessment of the primary endpoint.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

67 participants

Primary outcome timeframe

Baseline and Week 52

Results posted on

2020-06-29

Participant Flow

This was a multicenter study conducted at 29 sites in Europe (Spain 10, United Kingdom (UK) 9, Germany 4, France 3 and Italy 3). A total of 67 participants with New-onset type 1 diabetes mellitus (NOT1DM) were randomized.

Study was terminated early as part of the decision to withdraw albiglutide for commercial reasons. Study stopped after 67 participants were randomized instead of 68 as per protocol. Impact of early termination was minimal and did not affect the interpretation of results.

Participant milestones

Participant milestones
Measure	Placebo Matching placebo was administered once weekly for 52 weeks by subcutaneous (sc) injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide Albiglutide 30 milligram (mg) was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).
Overall Study STARTED	17	50
Overall Study COMPLETED	11	40
Overall Study NOT COMPLETED	6	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Matching placebo was administered once weekly for 52 weeks by subcutaneous (sc) injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide Albiglutide 30 milligram (mg) was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).
Overall Study Adverse Event	3	0
Overall Study Lost to Follow-up	1	3
Overall Study Physician Decision	0	2
Overall Study Withdrawal by Subject	2	5

Baseline Characteristics

Albiglutide Versus Placebo in Insulin-treated Subjects With New-onset Type 1 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=17 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=50 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	Total n=67 Participants Total of all reporting groups
Race/Ethnicity, Customized White	17 Participants n=5 Participants	49 Participants n=7 Participants	66 Participants n=5 Participants
Age, Continuous	22.8 Years STANDARD_DEVIATION 3.83 • n=5 Participants	22.7 Years STANDARD_DEVIATION 3.72 • n=7 Participants	22.7 Years STANDARD_DEVIATION 3.72 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	21 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	29 Participants n=7 Participants	39 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 52

Population: ITT Population. Only those participants with available data at the specified time points were analyzed. Time normalized plasma C-peptide AUC was calculated using trapezoidal rule then dividing by 120 (if the result at t=120 is non-missing otherwise the time difference between first and last times with non-missing results is used)

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=40 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo n=53 Participants Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Mean Change From Baseline in Time Normalized Stimulated (From Mixed Meal Tolerance Test [MMTT]) 2-hour Plasma C-peptide Area Under the Curve (AUC) at Week 52	-0.16 Nanomoles per liter Standard Deviation 0.366	-0.13 Nanomoles per liter Standard Deviation 0.244	-0.27 Nanomoles per liter Standard Deviation 0.314

SECONDARY outcome

Timeframe: Baseline and Weeks 16, 28 and 64

Population: ITT Population. Only parts with data available at specified data points were analyzed (represented by n= X in the category titles).Time normalized plasma C-peptide AUC was calculated using trapezoidal rule then dividing by 120 (if result at t=120 is non-missing otherwise time difference between first and last times with non-missing results is used)

Participants had a balanced diet consistent with dietitian's advice and made no major changes in exercise regimens. On the evening before the MMTT, participants had a full meal and then fasted from 9 pm until the MMTT was completed. Water, black coffee or tea without sugar or artificial sweeteners was allowed. Plasma glucose was measured prior to the test using a finger-stick test and MMTT was performed only if it was in range \> 3.9 mmol/L (70 mg/dL) and \<= 11.1 mmol/L (200 mg/dL). Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=46 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Mean Change From Baseline in Time Normalized Stimulated (From MMTT) 2 Hour Plasma C-peptide AUC at Week 16, 28 and Week 64 Week 16, n=15,44	0.00 Nanomoles per liter Standard Deviation 0.216	0.07 Nanomoles per liter Standard Deviation 0.234	—
Mean Change From Baseline in Time Normalized Stimulated (From MMTT) 2 Hour Plasma C-peptide AUC at Week 16, 28 and Week 64 Week 28, n=13,41	-0.14 Nanomoles per liter Standard Deviation 0.177	0.01 Nanomoles per liter Standard Deviation 0.225	—
Mean Change From Baseline in Time Normalized Stimulated (From MMTT) 2 Hour Plasma C-peptide AUC at Week 16, 28 and Week 64 Week 64, n=11,36	-0.22 Nanomoles per liter Standard Deviation 0.277	-0.22 Nanomoles per liter Standard Deviation 0.246	—

SECONDARY outcome

Timeframe: Baseline and Weeks 16, 28, 52 and 64

Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Maximum stimulated plasma C-peptide was the highest value at any time point during the 2 hour MMTT after the participant has ingested the mixed meal at Baseline, Week 16, Week 28, Week 52 and Week 64. Blood samples were taken to assess levels of C-peptide at: 10 minutes before Time 0 (-10 minutes), Immediately before the participant starts drinking the nutritional drink (Time 0) and 15, 30, 60, 90, and 120 minutes after Time 0.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=46 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Maximum Stimulated Plasma C-peptide (MMTT) at Baseline, Week 16, 28, 52 and 64 Baseline, n=15,46	0.86 Nanomoles per liter Standard Deviation 0.382	0.82 Nanomoles per liter Standard Deviation 0.448	—
Maximum Stimulated Plasma C-peptide (MMTT) at Baseline, Week 16, 28, 52 and 64 Week 16, n=15,45	0.84 Nanomoles per liter Standard Deviation 0.481	1.02 Nanomoles per liter Standard Deviation 0.558	—
Maximum Stimulated Plasma C-peptide (MMTT) at Baseline, Week 16, 28, 52 and 64 Week 28,n=13,42	0.68 Nanomoles per liter Standard Deviation 0.442	0.91 Nanomoles per liter Standard Deviation 0.594	—
Maximum Stimulated Plasma C-peptide (MMTT) at Baseline, Week 16, 28, 52 and 64 Week 52,n=11,41	0.63 Nanomoles per liter Standard Deviation 0.516	0.69 Nanomoles per liter Standard Deviation 0.479	—
Maximum Stimulated Plasma C-peptide (MMTT) at Baseline, Week 16, 28, 52 and 64 Week 64, n=11,37	0.58 Nanomoles per liter Standard Deviation 0.453	0.48 Nanomoles per liter Standard Deviation 0.363	—

SECONDARY outcome

Timeframe: Baseline and Weeks 16, 28, 52 and 64

Population: ITT Population. Only parts with data available at specified data points were analyzed (represented by n= X in the category titles). Time normalized plasma glucagon AUC was calculated using trapezoidal rule then dividing by 120 (if result at t=120 is non-missing otherwise time difference between first and last times with non-missing results is used)

Blood samples were taken to assess levels of glucagon at: 10 minutes before Time 0 (-10 minutes), immediately before the participant started drinking the nutritional drink (Time 0) and 15, 30, 60, 90, and 120 minutes after Time 0. Mean change from Baseline in time normalized plasma glucagon AUC (from MMTT) at Week 16, 28, 52 and 64 was reported. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=46 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Mean Change From Baseline in Time Normalized Plasma Glucagon AUC (From MMTT) at Week 16, 28, 52 and 64 Week 16,n=15,45	-2.28 Nanograms per liter Standard Deviation 11.221	-1.10 Nanograms per liter Standard Deviation 4.496	—
Mean Change From Baseline in Time Normalized Plasma Glucagon AUC (From MMTT) at Week 16, 28, 52 and 64 Week 28,n=13,43	-2.97 Nanograms per liter Standard Deviation 11.574	3.91 Nanograms per liter Standard Deviation 22.197	—
Mean Change From Baseline in Time Normalized Plasma Glucagon AUC (From MMTT) at Week 16, 28, 52 and 64 Week 52,n=11,40	-0.31 Nanograms per liter Standard Deviation 15.989	4.66 Nanograms per liter Standard Deviation 13.628	—
Mean Change From Baseline in Time Normalized Plasma Glucagon AUC (From MMTT) at Week 16, 28, 52 and 64 Week 64,n=11,37	3.19 Nanograms per liter Standard Deviation 18.279	8.82 Nanograms per liter Standard Deviation 17.650	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 16, 28, 40, 52 and 64

Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Responders were defined as participants achieving glycosylated hemoglobin A1c (HbA1c) \<= 7.0 percent and mean daily insulin use \< 0.5 units per kilograms (kg) per day. Percentages are based on the number of participants with available HbA1c and insulin use data in each treatment group at that visit.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=46 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Percentage of Responders at Baseline, Weeks 4, 8, 16, 28, 40, 52 and 64 Baseline, n=15, 46	26.7 Percentage of participants	37.0 Percentage of participants	—
Percentage of Responders at Baseline, Weeks 4, 8, 16, 28, 40, 52 and 64 Week 4,n=14,42	71.4 Percentage of participants	78.6 Percentage of participants	—
Percentage of Responders at Baseline, Weeks 4, 8, 16, 28, 40, 52 and 64 Week 8,n=14,46	85.7 Percentage of participants	67.4 Percentage of participants	—
Percentage of Responders at Baseline, Weeks 4, 8, 16, 28, 40, 52 and 64 Week 16,n=15,45	86.7 Percentage of participants	73.3 Percentage of participants	—
Percentage of Responders at Baseline, Weeks 4, 8, 16, 28, 40, 52 and 64 Week 28,n=12,42	75.0 Percentage of participants	73.8 Percentage of participants	—
Percentage of Responders at Baseline, Weeks 4, 8, 16, 28, 40, 52 and 64 Week 40,n=13,40	76.9 Percentage of participants	62.5 Percentage of participants	—
Percentage of Responders at Baseline, Weeks 4, 8, 16, 28, 40, 52 and 64 Week 52,n=12,41	41.7 Percentage of participants	48.8 Percentage of participants	—
Percentage of Responders at Baseline, Weeks 4, 8, 16, 28, 40, 52 and 64 Week 64,n=11,38	36.4 Percentage of participants	34.2 Percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 16, 28, 40, 52 and 64

Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Participant achieving partial remission status was defined as a participant with IDAA1C \<=9.0 . Percentages were based on the number of participants with available IDAA1c data in each treatment group at that visit.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=46 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Percentage of Participants Achieving Partial Remission Status (Insulin Dose-adjusted Hemoglobin A1c (IDAA1C)<= 9.0) at Baseline, Week 4, 8, 16, 28, 40, 52 and 64 Baseline, n= 15, 46	73.3 Percentage of participants	60.9 Percentage of participants	—
Percentage of Participants Achieving Partial Remission Status (Insulin Dose-adjusted Hemoglobin A1c (IDAA1C)<= 9.0) at Baseline, Week 4, 8, 16, 28, 40, 52 and 64 Week 4,n=14,42	92.9 Percentage of participants	88.1 Percentage of participants	—
Percentage of Participants Achieving Partial Remission Status (Insulin Dose-adjusted Hemoglobin A1c (IDAA1C)<= 9.0) at Baseline, Week 4, 8, 16, 28, 40, 52 and 64 Week 8,n=14,46	92.9 Percentage of participants	87.0 Percentage of participants	—
Percentage of Participants Achieving Partial Remission Status (Insulin Dose-adjusted Hemoglobin A1c (IDAA1C)<= 9.0) at Baseline, Week 4, 8, 16, 28, 40, 52 and 64 Week 16,n=15,45	86.7 Percentage of participants	86.7 Percentage of participants	—
Percentage of Participants Achieving Partial Remission Status (Insulin Dose-adjusted Hemoglobin A1c (IDAA1C)<= 9.0) at Baseline, Week 4, 8, 16, 28, 40, 52 and 64 Week 28,n=12,42	75.0 Percentage of participants	85.7 Percentage of participants	—
Percentage of Participants Achieving Partial Remission Status (Insulin Dose-adjusted Hemoglobin A1c (IDAA1C)<= 9.0) at Baseline, Week 4, 8, 16, 28, 40, 52 and 64 Week 40,n=13,40	84.6 Percentage of participants	82.5 Percentage of participants	—
Percentage of Participants Achieving Partial Remission Status (Insulin Dose-adjusted Hemoglobin A1c (IDAA1C)<= 9.0) at Baseline, Week 4, 8, 16, 28, 40, 52 and 64 Week 52,n=12,41	58.3 Percentage of participants	70.7 Percentage of participants	—
Percentage of Participants Achieving Partial Remission Status (Insulin Dose-adjusted Hemoglobin A1c (IDAA1C)<= 9.0) at Baseline, Week 4, 8, 16, 28, 40, 52 and 64 Week 64,n=11,38	54.5 Percentage of participants	55.3 Percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: ITT Population. Only those participants with available data at the specified time points were analyzed.

Change from Baseline in percent HbA1c was reported. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Change from Baseline was calculated by subtracting Baseline value from the Week 52 value.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=43 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Change From Baseline in Percent HbA1c at Week 52	-0.73 Percentage of HbA1c Standard Deviation 1.033	-0.59 Percentage of HbA1c Standard Deviation 1.649	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 16, 28, 40, 52 and 64

Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n=x in the category titles).

Blood samples were collected from participants for analysis of HbA1c at indicated time points and percentage of HbA1c has been calculated for Weeks 4, 8, 16, 28, 40, 52 and 64.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=46 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Percent HbA1c Over Time (at Weeks 4, 8, 16, 28, 40, 52 and 64) Week 4,n=15,43	6.29 Percentage of HbA1c Standard Deviation 0.688	6.10 Percentage of HbA1c Standard Deviation 0.725	—
Percent HbA1c Over Time (at Weeks 4, 8, 16, 28, 40, 52 and 64) Week 8,n=15,46	5.91 Percentage of HbA1c Standard Deviation 0.689	5.82 Percentage of HbA1c Standard Deviation 0.725	—
Percent HbA1c Over Time (at Weeks 4, 8, 16, 28, 40, 52 and 64) Week 16,n=15,46	5.97 Percentage of HbA1c Standard Deviation 0.801	5.78 Percentage of HbA1c Standard Deviation 0.733	—
Percent HbA1c Over Time (at Weeks 4, 8, 16, 28, 40, 52 and 64) Week 28,n=13,43	6.03 Percentage of HbA1c Standard Deviation 0.747	6.00 Percentage of HbA1c Standard Deviation 0.824	—
Percent HbA1c Over Time (at Weeks 4, 8, 16, 28, 40, 52 and 64) Week 40,n=13,42	6.22 Percentage of HbA1c Standard Deviation 0.860	6.20 Percentage of HbA1c Standard Deviation 0.894	—
Percent HbA1c Over Time (at Weeks 4, 8, 16, 28, 40, 52 and 64) Week 52,n=12,43	6.56 Percentage of HbA1c Standard Deviation 0.950	6.58 Percentage of HbA1c Standard Deviation 1.512	—
Percent HbA1c Over Time (at Weeks 4, 8, 16, 28, 40, 52 and 64) Week 64,n=12,40	7.12 Percentage of HbA1c Standard Deviation 1.335	6.92 Percentage of HbA1c Standard Deviation 1.176	—

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 16, 28, 40, 52 and 64

Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

The mean daily insulin use value was calculated, in units/kg/day as the sum of average prandial insulin doses and average of basal insulin doses for each participant recorded daily for the 3 days prior to the specified visits, divided by the participant's body weight in kg. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=46 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Change From Baseline in Mean Daily Insulin Use at Week 4, 8, 16, 28, 40, 52 and 64 Week 4,n=14,43	-0.02 Units/kg/day Standard Deviation 0.076	-0.03 Units/kg/day Standard Deviation 0.093	—
Change From Baseline in Mean Daily Insulin Use at Week 4, 8, 16, 28, 40, 52 and 64 Week 8,n=14,46	-0.04 Units/kg/day Standard Deviation 0.105	-0.02 Units/kg/day Standard Deviation 0.123	—
Change From Baseline in Mean Daily Insulin Use at Week 4, 8, 16, 28, 40, 52 and 64 Week 16,n=15,45	-0.05 Units/kg/day Standard Deviation 0.100	-0.01 Units/kg/day Standard Deviation 0.148	—
Change From Baseline in Mean Daily Insulin Use at Week 4, 8, 16, 28, 40, 52 and 64 Week 28,n=12,42	-0.01 Units/kg/day Standard Deviation 0.139	0.03 Units/kg/day Standard Deviation 0.145	—
Change From Baseline in Mean Daily Insulin Use at Week 4, 8, 16, 28, 40, 52 and 64 Week 40,n=13,40	-0.01 Units/kg/day Standard Deviation 0.151	0.03 Units/kg/day Standard Deviation 0.145	—
Change From Baseline in Mean Daily Insulin Use at Week 4, 8, 16, 28, 40, 52 and 64 Week 52,n=12,41	0.04 Units/kg/day Standard Deviation 0.119	0.11 Units/kg/day Standard Deviation 0.215	—
Change From Baseline in Mean Daily Insulin Use at Week 4, 8, 16, 28, 40, 52 and 64 Week 64,n=11,38	0.04 Units/kg/day Standard Deviation 0.140	0.10 Units/kg/day Standard Deviation 0.187	—

SECONDARY outcome

Timeframe: Week 24 to 52

Population: ITT Population. Only those participants with available data at specified time points were analyzed

Significant hypoglycemia was defined as an event with plasma glucose level \<= 3.9 mmol/L (\<= 70 mg/dL) and/or requiring third party intervention. This corresponds to American Diabetes Association (ADA) category definitions of severe, documented symptomatic, and asymptomatic hypoglycemia. The time period was defined as: \> Week 24 to \<= Week 52 = Day 169 to Day 364. Number of Events were defined as the total number of significant hypoglycemic events at each level of summarization. Number of events of hypoglycemia with confirmed self plasma glucose monitoring \<=3.9 mmol/L and/or requiring third party intervention (i.e., severe, documented symptomatic and asymptomatic hypoglycemic events) occurring \>Week 24 and \<=Week 52 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=45 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Number of Events of Participant-reported Significant Hypoglycemia, Occurring > Week 24 and <= Week 52 Any Significant Hypoglycemia	472 Hypoglycemic events	1592 Hypoglycemic events	—
Number of Events of Participant-reported Significant Hypoglycemia, Occurring > Week 24 and <= Week 52 Severe Hypoglycemia	0 Hypoglycemic events	0 Hypoglycemic events	—
Number of Events of Participant-reported Significant Hypoglycemia, Occurring > Week 24 and <= Week 52 Documented Symptomatic Hypoglycemia	241 Hypoglycemic events	996 Hypoglycemic events	—
Number of Events of Participant-reported Significant Hypoglycemia, Occurring > Week 24 and <= Week 52 Asymptomatic Hypoglycemia	231 Hypoglycemic events	596 Hypoglycemic events	—

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: ITT Population. Only those participants with available data at the specified time points were analysed (represented by n=X in the category titles).

Three days before the visit, the participants made an additional visit to the study site to have the CGM fitted/inserted. It was worn for 3 consecutive days and was removed at the scheduled study visit. Whilst wearing the CGM, participants continued to monitor their plasma glucose at least 4 times a day and on one of the days, conducted 7-point glucose profile (Before breakfast, 2 hours after breakfast, Before lunch, 2 hours after lunch, Before dinner, 2 hours after dinner, At bedtime). Time spent with a plasma glucose \<=3.9 millimoles per liter (mmol/L), between \>3.9 and 10.0 mmol/L, and \>10.0 mmol/L, respectively as performed by 72-hour CGM at Baseline, Week 28 and Week 52 was reported.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=46 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Time Spent With Plasma Glucose Level <= 3.9, > 3.9 to <= 10.0, and > 10.0 Measured by 72 Hour Continuous Glucose Monitoring (CGM) at Baseline, Week 28 and 52 <= 3.9 mmol/L, Baseline,n=14,42	0.80 hours per day Standard Deviation 1.251	0.98 hours per day Standard Deviation 1.400	—
Time Spent With Plasma Glucose Level <= 3.9, > 3.9 to <= 10.0, and > 10.0 Measured by 72 Hour Continuous Glucose Monitoring (CGM) at Baseline, Week 28 and 52 <= 3.9 mmol/L, Week 28,n=12,36	1.72 hours per day Standard Deviation 1.248	1.38 hours per day Standard Deviation 1.808	—
Time Spent With Plasma Glucose Level <= 3.9, > 3.9 to <= 10.0, and > 10.0 Measured by 72 Hour Continuous Glucose Monitoring (CGM) at Baseline, Week 28 and 52 <= 3.9 mmol/L, Week 52,n=10,31	1.60 hours per day Standard Deviation 2.142	1.36 hours per day Standard Deviation 2.405	—
Time Spent With Plasma Glucose Level <= 3.9, > 3.9 to <= 10.0, and > 10.0 Measured by 72 Hour Continuous Glucose Monitoring (CGM) at Baseline, Week 28 and 52 > 3.9 to <= 10.0 mmol/L,Baseline,n=14,42	20.14 hours per day Standard Deviation 3.675	19.11 hours per day Standard Deviation 3.732	—
Time Spent With Plasma Glucose Level <= 3.9, > 3.9 to <= 10.0, and > 10.0 Measured by 72 Hour Continuous Glucose Monitoring (CGM) at Baseline, Week 28 and 52 > 3.9 to <= 10.0 mmol/L,Week 28,n=12,36	18.93 hours per day Standard Deviation 3.452	18.83 hours per day Standard Deviation 4.009	—
Time Spent With Plasma Glucose Level <= 3.9, > 3.9 to <= 10.0, and > 10.0 Measured by 72 Hour Continuous Glucose Monitoring (CGM) at Baseline, Week 28 and 52 > 3.9 to <= 10.0 mmol/L,Week 52,n=10,31	17.98 hours per day Standard Deviation 4.491	18.19 hours per day Standard Deviation 4.772	—
Time Spent With Plasma Glucose Level <= 3.9, > 3.9 to <= 10.0, and > 10.0 Measured by 72 Hour Continuous Glucose Monitoring (CGM) at Baseline, Week 28 and 52 > 10.0 mmol/L, Baseline,n=14,42	3.06 hours per day Standard Deviation 3.560	3.90 hours per day Standard Deviation 3.727	—
Time Spent With Plasma Glucose Level <= 3.9, > 3.9 to <= 10.0, and > 10.0 Measured by 72 Hour Continuous Glucose Monitoring (CGM) at Baseline, Week 28 and 52 > 10.0 mmol/L,Week 28,n=12,36	3.35 hours per day Standard Deviation 3.115	3.79 hours per day Standard Deviation 3.782	—
Time Spent With Plasma Glucose Level <= 3.9, > 3.9 to <= 10.0, and > 10.0 Measured by 72 Hour Continuous Glucose Monitoring (CGM) at Baseline, Week 28 and 52 > 10.0 mmol/L,Week 52,n=10,31	4.42 hours per day Standard Deviation 4.597	4.45 hours per day Standard Deviation 4.781	—

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: ITT Population. Only evaluable participants, as defined in the Measure Description were analysed (represented by n=X in the category titles).

A hypoglycemic excursion was defined as an occurrence where the plasma glucose level \<=3.9 mmol/L (\<=70 mg/dL). At each visit, only evaluable participants, defined as those with \>= 4 non-missing glucose values or \>= 1 hypoglycemic excursions were included. Number of Hypoglycemic Excursions for each participant from 7-Point Glucose Profile (Before breakfast, 2 hours after breakfast, Before lunch, 2 hours after lunch, Before dinner, 2 hours after dinner, At bedtime) were reported. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=46 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Number of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52 Bseline,n=15,42	0.40 Hypoglycemic excursions Standard Deviation 0.632	0.36 Hypoglycemic excursions Standard Deviation 0.656	—
Number of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52 Week 28,n=13,40	0.31 Hypoglycemic excursions Standard Deviation 0.630	0.28 Hypoglycemic excursions Standard Deviation 0.554	—
Number of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52 Week 52,n=12,40	0.25 Hypoglycemic excursions Standard Deviation 0.452	0.40 Hypoglycemic excursions Standard Deviation 0.672	—

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: ITT Population. Only evaluable participants, as defined in the Measure Description were analysed (represented by n=X in the category titles).

A hypoglycemic excursion was defined as an occurrence where the plasma glucose level \<=3.9 mmol/L (\<= 70 mg/dL). At each visit, only evaluable participants, defined as those with \>= 4 non-missing glucose values or \>= 1 hypoglycemic excursions were included. Greatest hypoglycemic excursion was calculated as 3.9 mmol/L minus the lowest recorded glucose level during the 7-point glucose profile (Before breakfast, 2 hours after breakfast, Before lunch, 2 hours after lunch, Before dinner, 2 hours after dinner, At bedtime). If a participant had data recorded at that visit, but did not have a value \<= 3.9 mmol/L, their greatest hypoglycemic excursion were 0 mmol/L for that visit. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=46 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Greatest Magnitude of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52 Baseline,n=15,42	0.24 mmol/L Standard Deviation 0.470	0.22 mmol/L Standard Deviation 0.597	—
Greatest Magnitude of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52 Week 28,n=13,40	0.18 mmol/L Standard Deviation 0.359	0.08 mmol/L Standard Deviation 0.231	—
Greatest Magnitude of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52 Week 52,n=12,40	0.22 mmol/L Standard Deviation 0.484	0.17 mmol/L Standard Deviation 0.393	—

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: ITT Population. Only evaluable participants, as defined in the Measure Description were analysed (represented by n=X in the category titles).

A hyperglycemic excursion is defined as an occurrence where the plasma glucose level \> 10.0 mmol/L (\> 180 mg/dL). At each visit, only evaluable participants, defined as those with \>= 4 non-missing glucose values or \>= 1 hyperglycemic excursions were included. Number of Hyperglycemic Excursions for each participant from 7-Point Glucose Profile (Before breakfast, 2 hours after breakfast, Before lunch, 2 hours after lunch, Before dinner, 2 hours after dinner, At bedtime) were reported. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=46 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Number of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52 Baseline,n=15,43	0.80 Hyperglycemic excursions Standard Deviation 1.014	1.53 Hyperglycemic excursions Standard Deviation 1.502	—
Number of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52 Week 28,n=13,40	1.23 Hyperglycemic excursions Standard Deviation 1.301	0.73 Hyperglycemic excursions Standard Deviation 0.933	—
Number of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52 Week 52,n=12,40	1.17 Hyperglycemic excursions Standard Deviation 1.115	1.30 Hyperglycemic excursions Standard Deviation 1.522	—

SECONDARY outcome

Timeframe: Baseline and weeks 28 and 52

Population: ITT Population. Only evaluable participants, as defined in the Measure Description were analysed (represented by n=X in the category titles).

A hyperglycemic excursion is defined as an occurrence where the plasma glucose level \> 10.0 mmol/L (\> 180 mg/dL). At each visit, only evaluable participants, defined as those with \>= 4 non-missing glucose values or \>= 1 hyperglycemic excursions were included. Greatest hyperglycemic excursion was calculated as the largest recorded glucose level during the 7-point glucose profile (before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, at bedtime) minus 10.0 mmol/L. If a participant had data recorded at that visit, but does not have a value \> 10.0 mmol/L, their greatest hyperglycemic excursion would be 0 mmol/L for that visit. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=46 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Greatest Magnitude of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52 Baseline,n=15,43	0.94 mmol/L Standard Deviation 1.805	2.72 mmol/L Standard Deviation 3.466	—
Greatest Magnitude of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52 Week 28,n=13,40	2.05 mmol/L Standard Deviation 2.154	1.52 mmol/L Standard Deviation 2.493	—
Greatest Magnitude of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52 Week 52,n=12,40	2.19 mmol/L Standard Deviation 2.823	2.42 mmol/L Standard Deviation 3.042	—

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: ITT Population. Only those participants with available data at the specified time points were analyzed.

Change from Baseline in body weight of participants was reported. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Change from Baseline was calculated by subtracting the Baseline value from the Week 52 value.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=43 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Change From Baseline in Body Weight (Kilograms) at Week 52	0.26 Kilograms Standard Deviation 2.738	0.77 Kilograms Standard Deviation 3.504	—

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64

Population: ITT Population. Only participants with available data at the specified time points were summarized

Body weight was measured in kilograms for participants at indicated time points.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=46 Participants Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Weight Over Time (at Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64) Week 28,n=13, 43	66.08 kilograms Standard Deviation 11.767	65.32 kilograms Standard Deviation 13.252	—
Weight Over Time (at Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64) Week 40,n=13, 42	66.08 kilograms Standard Deviation 11.266	66.20 kilograms Standard Deviation 13.146	—
Weight Over Time (at Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64) Week 2,n=15, 43	70.16 kilograms Standard Deviation 14.087	66.16 kilograms Standard Deviation 11.944	—
Weight Over Time (at Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64) Week 4,n=15, 44	69.87 kilograms Standard Deviation 14.409	66.39 kilograms Standard Deviation 11.952	—
Weight Over Time (at Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64) Week 6,n=15, 46	69.83 kilograms Standard Deviation 14.013	65.65 kilograms Standard Deviation 12.559	—
Weight Over Time (at Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64) Week 8,n=15, 46	70.08 kilograms Standard Deviation 14.121	65.32 kilograms Standard Deviation 12.825	—
Weight Over Time (at Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64) Week 16,n=15, 46	69.40 kilograms Standard Deviation 15.191	65.41 kilograms Standard Deviation 12.824	—
Weight Over Time (at Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64) Week 52,n=12, 43	66.86 kilograms Standard Deviation 12.401	66.80 kilograms Standard Deviation 12.696	—
Weight Over Time (at Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64) Week 64,n=12, 40	68.29 kilograms Standard Deviation 11.511	68.13 kilograms Standard Deviation 12.649	—

SECONDARY outcome

Timeframe: 48 hours after the most recent dose at Week 4, 6, 8 and 16

Population: PK population which comprised of participants in 'Safety Population' for whom a pharmacokinetic sample was obtained and analyzed. Only participants who received albiglutide were included in PK Population.

PK of Albiglutide was evaluated in participants using CL/F using PK samples collected on Weeks 4, 6, 8, 16. CL/F was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean body weights of 67 kilograms, and electronic glomerular filtration rate (eGFR) of 123 milliliters per minute.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Population Estimates of Pharmacokinetic (PK) Parameters: Apparent Clearance [CL/F]	45.1 Milliliters per hour Standard Error 2.56	—	—

SECONDARY outcome

Timeframe: 48 hours after the most recent dose at Week 4, 6, 8 and 16

Population: PK population

PK of Albiglutide was evaluated in participants using V/F using PK samples collected on Weeks 4, 6, 8, 16. V/F was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean body weights of 67 kilograms, and eGFR of 123 milliliters per minute.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Population Estimates of PK Parameters: Apparent Volume of Distribution [V/F]	4830 Milliliters Standard Error 677	—	—

SECONDARY outcome

Timeframe: 48 hours after the most recent dose at Week 4, 6, 8 and 16

Population: PK population

PK of Albiglutide was evaluated in participants using Ka using PK samples collected on Weeks 4, 6, 8, 16. Ka was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean bodyweights of 67 kilograms, and eGFR of 123 milliliters per minute.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).	DEFEND-1 Placebo Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge.
Population Estimates of PK Parameters: First-order Absorption Rate Constant [Ka]	0.0122 Per hour Standard Error 0.0022	—	—

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Albiglutide

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=17 participants at risk Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin.	Albiglutide n=50 participants at risk Albiglutide 30 mg was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region along with insulin (Dose increased to 50 mg once weekly at Week 6 if the 30 mg weekly dose was tolerated).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/17 • On-therapy AEs and SAEs were collected from start of study treatment up to 52-weeks AEs and SAEs were summarized in Safety Population. Safety Population comprised of all participants who received at least one dose of study treatment.	2.0% 1/50 • On-therapy AEs and SAEs were collected from start of study treatment up to 52-weeks AEs and SAEs were summarized in Safety Population. Safety Population comprised of all participants who received at least one dose of study treatment.
Psychiatric disorders Suicidal ideation	5.9% 1/17 • On-therapy AEs and SAEs were collected from start of study treatment up to 52-weeks AEs and SAEs were summarized in Safety Population. Safety Population comprised of all participants who received at least one dose of study treatment.	0.00% 0/50 • On-therapy AEs and SAEs were collected from start of study treatment up to 52-weeks AEs and SAEs were summarized in Safety Population. Safety Population comprised of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Urticaria	5.9% 1/17 • On-therapy AEs and SAEs were collected from start of study treatment up to 52-weeks AEs and SAEs were summarized in Safety Population. Safety Population comprised of all participants who received at least one dose of study treatment.	0.00% 0/50 • On-therapy AEs and SAEs were collected from start of study treatment up to 52-weeks AEs and SAEs were summarized in Safety Population. Safety Population comprised of all participants who received at least one dose of study treatment.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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