| Primary | 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 | 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. | 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) | Posted | | Mean | Standard Deviation | Nanomoles per liter | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin. | | OG001 | 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). | | OG002 | DEFEND-1 Placebo | Historical placebo data from the DEFEND-1 (NCT00678886) study was used as prior knowledge. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-0.16± 0.366
- OG001-0.13± 0.244
- OG002-0.27± 0.314
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | Mean Difference (Final Values) | 0.12 | | | 2-Sided | 95 | 0.00 | 0.24 | | | Analysis was performed using a Bayesian model incorporating historical placebo data using a robust mixture prior. Values above are 95% credible intervals. Probability of treatment difference (Albiglutide - Placebo) >= 0.2 nmol/L = 0.097. | | Superiority | | |
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| Secondary | Mean Change From Baseline in Time Normalized Stimulated (From MMTT) 2 Hour Plasma C-peptide AUC at Week 16, 28 and Week 64 | 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. | 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) | Posted | | Mean | Standard Deviation | Nanomoles per liter | | Baseline and Weeks 16, 28 and 64 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin. | | OG001 | Albiglutide | |
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| Secondary | Maximum Stimulated Plasma C-peptide (MMTT) at Baseline, Week 16, 28, 52 and 64 | 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. | ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Nanomoles per liter | | Baseline and Weeks 16, 28, 52 and 64 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin. | | OG001 | 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). |
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| Secondary | Mean Change From Baseline in Time Normalized Plasma Glucagon AUC (From MMTT) at Week 16, 28, 52 and 64 | 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. | 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) | Posted | | Mean | Standard Deviation | Nanograms per liter | | Baseline and Weeks 16, 28, 52 and 64 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin. | | OG001 | 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). |
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| Secondary | Percentage of Responders at Baseline, Weeks 4, 8, 16, 28, 40, 52 and 64 | 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. | ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Number | | Percentage of participants | | Baseline and Weeks 4, 8, 16, 28, 40, 52 and 64 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin. | | OG001 | 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). |
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| Secondary | 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 | 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. | ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Number | | Percentage of participants | | Baseline and Weeks 4, 8, 16, 28, 40, 52 and 64 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin. | | OG001 | 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). |
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| Secondary | Change From Baseline in Percent HbA1c at Week 52 | 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. | ITT Population. Only those participants with available data at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Percentage of HbA1c | | Baseline and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin. | | OG001 | 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). |
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| Secondary | Percent HbA1c Over Time (at Weeks 4, 8, 16, 28, 40, 52 and 64) | 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. | ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n=x in the category titles). | Posted | | Mean | Standard Deviation | Percentage of HbA1c | | Weeks 4, 8, 16, 28, 40, 52 and 64 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin. | | OG001 | 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). |
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| Secondary | Change From Baseline in Mean Daily Insulin Use at Week 4, 8, 16, 28, 40, 52 and 64 | 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. | ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Units/kg/day | | Baseline and Weeks 4, 8, 16, 28, 40, 52 and 64 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin. | | OG001 | 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). |
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| Secondary | Number of Events of Participant-reported Significant Hypoglycemia, Occurring > Week 24 and <= Week 52 | 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. | ITT Population. Only those participants with available data at specified time points were analyzed | Posted | | Number | | Hypoglycemic events | | Week 24 to 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin. | | OG001 | 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). |
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| Secondary | 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 | 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. | ITT Population. Only those participants with available data at the specified time points were analysed (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | hours per day | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin. | | OG001 | 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). |
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| Secondary | Number of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52 | 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. | ITT Population. Only evaluable participants, as defined in the Measure Description were analysed (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Hypoglycemic excursions | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin. | | OG001 | 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). |
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| Secondary | Greatest Magnitude of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52 | 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. | ITT Population. Only evaluable participants, as defined in the Measure Description were analysed (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin. | | OG001 | 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). |
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| Secondary | Number of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52 | 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. | ITT Population. Only evaluable participants, as defined in the Measure Description were analysed (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | Hyperglycemic excursions | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin. | | OG001 | 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). |
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| Secondary | Greatest Magnitude of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52 | 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. | ITT Population. Only evaluable participants, as defined in the Measure Description were analysed (represented by n=X in the category titles). | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin. | | OG001 | 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). |
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| Secondary | Change From Baseline in Body Weight (Kilograms) at Week 52 | 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. | ITT Population. Only those participants with available data at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Kilograms | | Baseline and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin. | | OG001 | 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). |
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| Secondary | Weight Over Time (at Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64) | Body weight was measured in kilograms for participants at indicated time points. | ITT Population. Only participants with available data at the specified time points were summarized | Posted | | Mean | Standard Deviation | kilograms | | Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Matching placebo was administered once weekly for 52 weeks by sc injection in the abdomen, thigh or upper arm region in addition to insulin. | | OG001 | 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). |
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| Secondary | Population Estimates of Pharmacokinetic (PK) Parameters: Apparent Clearance [CL/F] | 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. | 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. | Posted | | Mean | Standard Error | Milliliters per hour | | 48 hours after the most recent dose at Week 4, 6, 8 and 16 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
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| Secondary | Population Estimates of PK Parameters: Apparent Volume of Distribution [V/F] | 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. | | Posted | | Mean | Standard Error | Milliliters | | 48 hours after the most recent dose at Week 4, 6, 8 and 16 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
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| Secondary | Population Estimates of PK Parameters: First-order Absorption Rate Constant [Ka] | 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. | | Posted | | Mean | Standard Error | Per hour | | 48 hours after the most recent dose at Week 4, 6, 8 and 16 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
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