Diabetes Mellitus
Conditions
Keywords
cardiovascular events /outcomes, Type 2 diabetes mellitus, albiglutide, glucagon-like peptide-1 receptor agonist
Brief summary
Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments.
Interventions
BIOLOGICALAlbiglutide 30 mg
Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.
BIOLOGICALAlbiglutide 50 mg
Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.
BIOLOGICALAlbiglutide matching placebo
Once weekly subcutaneous injection. Matched to 30 mg and 50 mg albiglutide.
Sponsors
Duke Clinical Research Institute
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women at least 40 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy. * Diagnosis of type 2 diabetes. * Established cardiovascular disease with at least one of the following: coronary artery disease, cerebrovascular disease, or peripheral arterial disease. * HbA1c \>7.0% (53 mmol/mol) (based on the most recent documented laboratory measurement within 6 months). * Able and willing to provide informed consent.
Exclusion criteria
* Severely reduced kidney function: eGFR \<30 ml/min/1.73 m\^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy. * Use of a GLP-1 receptor agonist at Screening. * Severe gastroparesis * History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study. * Personal or family history of medullary carcinoma of the thyroid or subject with multiple endocrine neoplasia type 2 (MEN-2). Personal history of pancreatic neuroendocrine tumours. * Medical history which might limit the subject's ability to take trial treatments for the duration of the study or to otherwise complete the study. * Breastfeeding, pregnancy, or planning a pregnancy during the course of the study. Note: a pregnancy test will be performed on all women of child bearing potential prior to study entry. * Known allergy to any GLP-1 receptor agonist or excipients of albiglutide. * Use of another investigational product within 30 days or according to local regulations, or currently enrolled in a study of an investigational device. * Any other reason the investigator deems the subject to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period | Median of 1.65 person years for CV follow-up time period | Time to MACE defined as the time to first occurrence of Cardiovascular Endpoint Committee (CEC)-adjudicated MACE (CV death, myocardial infarction \[MI\] or stroke) was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. The analysis was performed on the Intent to Treat (ITT) Population which comprised of all randomized participants excluding participants who did not provide consent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Adjudicated CV Death | Median of 1.65 person years for the CV follow-up time period | Time to adjudicated CV death was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. |
| Time to First Occurrence of Adjudicated MI | Median of 1.65 person years for CV follow-up time period | Time to first occurrence of adjudicated MI was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. |
| Time to First Occurrence of Adjudicated Stroke | Median of 1.65 person years for CV follow-up time period | Time to first occurrence of adjudicated stroke was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. |
| Time to First Occurrence of Adjudicated CV Death or Hospitalization for Heart Failure (HF) | Median of 1.65 person years for CV follow-up time period | Time to first occurrence of adjudicated CV death or hospitalization for HF was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. |
| Time to Initiation of Insulin of More Than 3 Months Duration for Those Participants Not Treated With Insulin at Study Start | Up to 2.7 years | Time to initiation of insulin of more than 3 months duration in participants not treated with insulin at study start was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period. The analysis was performed on Non-Insulin Population which comprised of participants in the ITT Population who were not on insulin at Baseline. |
| Time to Initiation of Prandial Insulin in Those Participants on Basal Insulin at Study Start | Up to 2.7 years | Time to initiation of prandial insulin in those participants on basal insulin at study start was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period. The analysis was performed on Basal Insulin Population which comprised of participants in the ITT Population who were on basal insulin but not on other insulin at Baseline (i.e., will not include a participant on a mixed insulin or on a prandial-only insulin). |
| Percentage of Participants Achieving Composite Metabolic Endpoint | Months 8, 16, 24 and final assessment (up to 2.7 years) | Percentage of participants achieving composite metabolic endpoint defined as the percentage of participants achieving glycemic control (glycated hemoglobin \[HbA1c\] \<=7% ) with no severe hypoglycemic incidents and weight gain \< 5%. Final Assessment is the latest post-Baseline assessment of both HbA1c and weight. |
| Time to First Occurrence of a Clinically Important Microvascular Event | Up to 2.7 years | Clinically important microvascular events were defined as the following: need for renal transplant or dialysis, new diabetes-related blindness, and procedures (laser photocoagulation or anti-vascular endothelial growth factor treatment or vitrectomy for diabetic retinopathy/eye disease). Time to first occurrence of a clinically important microvascular event was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period. |
| Change From Baseline in HbA1c | Baseline and Months 8 and 16 | Change from Baseline in HbA1c was analyzed using mixed model repeated measures (MMRM) including observed case data (does not impute any missing data). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. Change from Baseline in HbA1c using Baseline data from Local or Central Laboratory, and post-Baseline Central Laboratory data is presented. |
| Time to First Occurrence of MACE or Urgent Revascularization for Unstable Angina | Median of 1.65 person years for CV follow-up time period | Time to first occurrence of CEC-adjudicated MACE (CV death, MI or stroke) or urgent revascularization for unstable angina was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. |
| Change From Baseline in Treatment Related Impact Measures-Diabetes (TRIM-D) Total Score | Baseline and Months 8 and 16 | The TRIM-D is a 28 item treatment satisfaction measure with 5 domains assessing Treatment Burden, Daily Life, Diabetes Management, Compliance and Psychological Health. The raw score ranges for each subscale were: treatment burden (6 to 30), daily life (5 to 25), diabetes management (5 to 25), compliance (4 to 20) and psychological health (8 to 40), higher scores indicating better health state. Total raw score was determined by summing the raw scores for each of the subscales and the total score (transformed) was determined as \[(raw score minus lowest possible raw score)/possible raw score range\] x100. The possible total (transformed) score range is 0-100, where higher scores indicated better health state. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. |
| Change From Baseline in EuroQol- 5 Dimension (EQ-5D) Visual Analogue Scale (VAS) Score | Baseline and Months 8 and 16 | The EQ-5D is a standardized instrument used to evaluate generic health-related quality of life, comprising 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It provides a simple descriptive profile and a single index value for health status. The EQ-5D self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. |
| Time to Death | Median of 1.73 years for the Vital Status follow-up time period | Time to death was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants who died/endpoint person-years) is presented along with 95% confidence interval. Endpoint person-years=(cumulative total time to event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the Vital Status follow-up time period. |
| Number of Participants With Non-fatal Serious Adverse Events (SAEs) | Up to 2.7 years | SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before; is associated with liver injury and impaired liver function. Number of participants with on-therapy non-fatal SAEs are presented. Safety Population comprised of all randomized participants who received at least one dose of study treatment. |
| Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Investigational Product (AELD) | Up to 2.7 years | The number of participants with on-therapy AEs leading to discontinuation of investigational product is reported. |
| Number of Participants With AEs of Special Interest | Up to 2.7 years | The protocol defined AEs of special interest included: development of thyroid cancer; hematologic malignancy; pancreatic cancer; pancreatitis (investigator reported and pancreatitis positively adjudicated by the Pancreatic Adjudication Committee \[PAC\]); investigational product injection site reactions; immunological reactions; severe hypoglycemic events; hepatic events; hepatic enzyme elevations (including gamma glutamyl transferase \[GGT\]); serious gastrointestinal (GI) events; appendicitis; atrial fibrillation/flutter; pneumonia; worsening renal function and diabetic retinopathy. The number of participants with on-therapy AEs of special interest is reported. |
| Change in Estimated Glomerular Filtration Rate (eGFR) Calculated Using Modification of Diet in Renal Disease (MDRD) Formula | Baseline and Months 8 and 16 | Blood samples were collected for the measurement of serum creatinine. Serum creatinine values were used to calculate eGFR using the MDRD formula, eGFR=175 x (serum creatinine)\^-1.154 x (Age)\^-0.203 x (0.742 if female) x (1.212 if African American). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. Change from Baseline in eGFR using Baseline data from Local or Central Laboratory, and post-Baseline Central Laboratory data for the on-treatment time period is presented. |
| Change From Baseline in Blood Pressure | Baseline and Months 8,16,24 and end of study (up to 2.7 years) | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were taken with the participant in a semi-recumbent or seated position after at least a 5-minute rest period. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. |
| Change From Baseline in Heart Rate | Baseline and Months 8, 16, 24 and end of study (up to 2.7 years) | Heart rate was measured with the participant in a semi-recumbent or seated position after at least a 5-minute rest period. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. |
| Change From Baseline in Body Weight | Baseline and Months 8 and 16 | Change from Baseline in body weight was analyzed using mixed model repeated measures including observed case data (does not impute any missing data). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. |
Countries
Argentina, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Italy, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
This was a randomized, double-blind, parallel group, placebo-controlled study in participants with Type 2 diabetes having a previous history of cardiovascular disease and not having optimal glycemic control.
Pre-assignment details
A total of 10793 participants were screened of which 1330 failed screening and 9463 participants were randomized in a 1:1 ratio to receive either once weekly albiglutide or matching placebo subcutaneous injections. The study was conducted in 28 countries
Participants by arm
| Arm | Count |
|---|---|
| Placebo Albiglutide matching placebo was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region in addition to the standard of care therapy for diabetes and cardiovascular health. | 4,732 |
| Albiglutide Albiglutide was administered once weekly as subcutaneous injection in the abdomen, thigh or upper arm region. Participants were administered albiglutide at a dose of 30 milligrams (mg) or 50 mg once weekly in addition to the standard of care therapy for diabetes and cardiovascular health.. | 4,731 |
| Total | 9,463 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Investigator site closed | 4 | 5 |
| Overall Study | Lost to Follow-up | 68 | 51 |
| Overall Study | Physician Decision | 8 | 12 |
| Overall Study | Withdrawal by Subject | 74 | 43 |
Baseline characteristics
| Characteristic | Placebo | Albiglutide | Total |
|---|---|---|---|
| Age, Continuous | 64.2 Years STANDARD_DEVIATION 8.65 | 64.1 Years STANDARD_DEVIATION 8.71 | 64.1 Years STANDARD_DEVIATION 8.68 |
| Race/Ethnicity, Customized Race, customized American Indian (Amer. Ind.) or Alaska Native | 238 Participants | 280 Participants | 518 Participants |
| Race/Ethnicity, Customized Race, customized Amer Ind. or Alaska Native & Black or African Amer | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Race, customized Amer. Ind. or Alaska Native & White | 24 Participants | 20 Participants | 44 Participants |
| Race/Ethnicity, Customized Race, customized Asian & Black or African Amer. | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race, customized Asian & White | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race, customized Black or African American (Amer.) | 118 Participants | 121 Participants | 239 Participants |
| Race/Ethnicity, Customized Race, customized Black or African Amer. & White | 81 Participants | 67 Participants | 148 Participants |
| Race/Ethnicity, Customized Race, customized Central/South Asian Heritage (Her.) | 27 Participants | 25 Participants | 52 Participants |
| Race/Ethnicity, Customized Race, customized Japanese Her./East Asian Her/South East Asian Her. | 215 Participants | 204 Participants | 419 Participants |
| Race/Ethnicity, Customized Race, customized Native Hawaiian or Other Pacific Islander | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Race, customized Unknown | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race, customized White | 4024 Participants | 4006 Participants | 8030 Participants |
| Sex: Female, Male Female | 1467 Participants | 1427 Participants | 2894 Participants |
| Sex: Female, Male Male | 3265 Participants | 3304 Participants | 6569 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 196 / 4,731 | 205 / 4,732 |
| other Total, other adverse events | 0 / 4,717 | 0 / 4,715 |
| serious Total, serious adverse events | 932 / 4,717 | 1,022 / 4,715 |
Outcome results
Primary
Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period
Time to MACE defined as the time to first occurrence of Cardiovascular Endpoint Committee (CEC)-adjudicated MACE (CV death, myocardial infarction \[MI\] or stroke) was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. The analysis was performed on the Intent to Treat (ITT) Population which comprised of all randomized participants excluding participants who did not provide consent.
Time frame: Median of 1.65 person years for CV follow-up time period
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period | 5.87 Events per 100 person years |
| Albiglutide | Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period | 4.57 Events per 100 person years |
p-value: <0.000195% CI: [0.68, 0.9]Wald test
p-value: <0.001Wald test
Secondary
Change From Baseline in Blood Pressure
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were taken with the participant in a semi-recumbent or seated position after at least a 5-minute rest period. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.
Time frame: Baseline and Months 8,16,24 and end of study (up to 2.7 years)
Population: Safety Population. Only those participants with a value at Baseline and specified visit were analyzed (represented n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Blood Pressure | SBP, Month 8; n=4241, 4319 | -0.5 Millimeter of mercury | Standard Deviation 17.33 |
| Placebo | Change From Baseline in Blood Pressure | SBP, Month 16; n=3082, 3187 | -0.5 Millimeter of mercury | Standard Deviation 17.45 |
| Placebo | Change From Baseline in Blood Pressure | SBP, Month 24; n=1133, 1198 | -0.9 Millimeter of mercury | Standard Deviation 18.62 |
| Placebo | Change From Baseline in Blood Pressure | SBP, End of study; n=3897, 4015 | 0.0 Millimeter of mercury | Standard Deviation 17.68 |
| Placebo | Change From Baseline in Blood Pressure | DBP, Month 8; n=4241, 4319 | -0.5 Millimeter of mercury | Standard Deviation 10.26 |
| Placebo | Change From Baseline in Blood Pressure | DBP, Month 16; n=3082, 3187 | -0.9 Millimeter of mercury | Standard Deviation 10.74 |
| Placebo | Change From Baseline in Blood Pressure | DBP, Month 24; n=1133, 1198 | -1.1 Millimeter of mercury | Standard Deviation 10.87 |
| Placebo | Change From Baseline in Blood Pressure | DBP, End of study; n=3897, 4015 | -0.7 Millimeter of mercury | Standard Deviation 10.66 |
| Albiglutide | Change From Baseline in Blood Pressure | DBP, End of study; n=3897, 4015 | -0.6 Millimeter of mercury | Standard Deviation 10.57 |
| Albiglutide | Change From Baseline in Blood Pressure | SBP, Month 8; n=4241, 4319 | -1.0 Millimeter of mercury | Standard Deviation 16.8 |
| Albiglutide | Change From Baseline in Blood Pressure | DBP, Month 8; n=4241, 4319 | -0.4 Millimeter of mercury | Standard Deviation 10.12 |
| Albiglutide | Change From Baseline in Blood Pressure | SBP, Month 16; n=3082, 3187 | -0.9 Millimeter of mercury | Standard Deviation 17.58 |
| Albiglutide | Change From Baseline in Blood Pressure | DBP, Month 24; n=1133, 1198 | -1.0 Millimeter of mercury | Standard Deviation 10.29 |
| Albiglutide | Change From Baseline in Blood Pressure | SBP, Month 24; n=1133, 1198 | -1.2 Millimeter of mercury | Standard Deviation 17.51 |
| Albiglutide | Change From Baseline in Blood Pressure | DBP, Month 16; n=3082, 3187 | -0.5 Millimeter of mercury | Standard Deviation 10.39 |
| Albiglutide | Change From Baseline in Blood Pressure | SBP, End of study; n=3897, 4015 | -0.4 Millimeter of mercury | Standard Deviation 17.58 |
Secondary
Change From Baseline in Body Weight
Change from Baseline in body weight was analyzed using mixed model repeated measures including observed case data (does not impute any missing data). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.
Time frame: Baseline and Months 8 and 16
Population: ITT Population. Only those participants with value at Baseline and at the specified visit is presented (represented by n=X in category titles)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Body Weight | Month 8, n=4217, 4286 | -0.36 Kilograms | Standard Error 0.062 |
| Placebo | Change From Baseline in Body Weight | Month 16, n=3068, 3173 | -0.53 Kilograms | Standard Error 0.084 |
| Albiglutide | Change From Baseline in Body Weight | Month 8, n=4217, 4286 | -1.02 Kilograms | Standard Error 0.061 |
| Albiglutide | Change From Baseline in Body Weight | Month 16, n=3068, 3173 | -1.36 Kilograms | Standard Error 0.083 |
p-value: <0.00195% CI: [-0.83, -0.49]t-test, 2 sided
p-value: <0.00195% CI: [-1.06, -0.6]t-test, 2 sided
Secondary
Change From Baseline in EuroQol- 5 Dimension (EQ-5D) Visual Analogue Scale (VAS) Score
The EQ-5D is a standardized instrument used to evaluate generic health-related quality of life, comprising 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It provides a simple descriptive profile and a single index value for health status. The EQ-5D self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.
Time frame: Baseline and Months 8 and 16
Population: ITT Population. Only those participants with value at Baseline and at the specified visit is presented (represented by n=X in category titles)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in EuroQol- 5 Dimension (EQ-5D) Visual Analogue Scale (VAS) Score | Month 8, n=3982, 4014 | 1.36 Scores on a scale | Standard Error 0.217 |
| Placebo | Change From Baseline in EuroQol- 5 Dimension (EQ-5D) Visual Analogue Scale (VAS) Score | Month 16, n=2347, 2481 | 1.87 Scores on a scale | Standard Error 0.287 |
| Albiglutide | Change From Baseline in EuroQol- 5 Dimension (EQ-5D) Visual Analogue Scale (VAS) Score | Month 8, n=3982, 4014 | 2.83 Scores on a scale | Standard Error 0.216 |
| Albiglutide | Change From Baseline in EuroQol- 5 Dimension (EQ-5D) Visual Analogue Scale (VAS) Score | Month 16, n=2347, 2481 | 2.39 Scores on a scale | Standard Error 0.279 |
p-value: <0.00195% CI: [0.87, 2.07]t-test, 2 sided
p-value: 0.19295% CI: [-0.26, 1.31]t-test, 2 sided
Secondary
Change From Baseline in HbA1c
Change from Baseline in HbA1c was analyzed using mixed model repeated measures (MMRM) including observed case data (does not impute any missing data). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. Change from Baseline in HbA1c using Baseline data from Local or Central Laboratory, and post-Baseline Central Laboratory data is presented.
Time frame: Baseline and Months 8 and 16
Population: ITT Population. Only those participants with value at Baseline and at the specified visit is presented (represented by n=X in category titles)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in HbA1c | Month 8, n=4211, 4289 | -0.28 Percentage of HbA1c | Standard Error 0.02 |
| Placebo | Change From Baseline in HbA1c | Month 16, n=3066, 3163 | -0.31 Percentage of HbA1c | Standard Error 0.023 |
| Albiglutide | Change From Baseline in HbA1c | Month 8, n=4211, 4289 | -0.92 Percentage of HbA1c | Standard Error 0.019 |
| Albiglutide | Change From Baseline in HbA1c | Month 16, n=3066, 3163 | -0.83 Percentage of HbA1c | Standard Error 0.022 |
p-value: <0.00195% CI: [-0.69, -0.58]t-test, 2 sided
p-value: <0.00195% CI: [-0.58, -0.45]t-test, 2 sided
Secondary
Change From Baseline in Heart Rate
Heart rate was measured with the participant in a semi-recumbent or seated position after at least a 5-minute rest period. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.
Time frame: Baseline and Months 8, 16, 24 and end of study (up to 2.7 years)
Population: Safety Population. Only those participants with a value at Baseline and specified visit were analyzed (represented n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Heart Rate | Month 8; n=4239, 4312 | 0.2 Beats per minute | Standard Deviation 9.99 |
| Placebo | Change From Baseline in Heart Rate | Month 16; n=3078, 3181 | 0.3 Beats per minute | Standard Deviation 10.19 |
| Placebo | Change From Baseline in Heart Rate | Month 24; n=1131, 1195 | 0.6 Beats per minute | Standard Deviation 10.84 |
| Placebo | Change From Baseline in Heart Rate | End of study; n=3892, 4005 | 0.8 Beats per minute | Standard Deviation 10.64 |
| Albiglutide | Change From Baseline in Heart Rate | End of study; n=3892, 4005 | 1.8 Beats per minute | Standard Deviation 10.5 |
| Albiglutide | Change From Baseline in Heart Rate | Month 8; n=4239, 4312 | 1.6 Beats per minute | Standard Deviation 10.07 |
| Albiglutide | Change From Baseline in Heart Rate | Month 24; n=1131, 1195 | 1.7 Beats per minute | Standard Deviation 10.32 |
| Albiglutide | Change From Baseline in Heart Rate | Month 16; n=3078, 3181 | 1.6 Beats per minute | Standard Deviation 10.16 |
Secondary
Change From Baseline in Treatment Related Impact Measures-Diabetes (TRIM-D) Total Score
The TRIM-D is a 28 item treatment satisfaction measure with 5 domains assessing Treatment Burden, Daily Life, Diabetes Management, Compliance and Psychological Health. The raw score ranges for each subscale were: treatment burden (6 to 30), daily life (5 to 25), diabetes management (5 to 25), compliance (4 to 20) and psychological health (8 to 40), higher scores indicating better health state. Total raw score was determined by summing the raw scores for each of the subscales and the total score (transformed) was determined as \[(raw score minus lowest possible raw score)/possible raw score range\] x100. The possible total (transformed) score range is 0-100, where higher scores indicated better health state. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.
Time frame: Baseline and Months 8 and 16
Population: ITT Population. Only those participants with value at Baseline and at the specified visit is presented (represented by n=X in category titles)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Treatment Related Impact Measures-Diabetes (TRIM-D) Total Score | Month 8, n=3013, 3041 | 4.53 Scores on a scale | Standard Error 0.194 |
| Placebo | Change From Baseline in Treatment Related Impact Measures-Diabetes (TRIM-D) Total Score | Month 16, n=1738, 1840 | 4.80 Scores on a scale | Standard Error 0.247 |
| Albiglutide | Change From Baseline in Treatment Related Impact Measures-Diabetes (TRIM-D) Total Score | Month 8, n=3013, 3041 | 6.92 Scores on a scale | Standard Error 0.193 |
| Albiglutide | Change From Baseline in Treatment Related Impact Measures-Diabetes (TRIM-D) Total Score | Month 16, n=1738, 1840 | 7.13 Scores on a scale | Standard Error 0.241 |
p-value: <0.00195% CI: [1.85, 2.93]t-test, 2 sided
p-value: <0.00195% CI: [1.66, 3.01]t-test, 2 sided
Secondary
Change in Estimated Glomerular Filtration Rate (eGFR) Calculated Using Modification of Diet in Renal Disease (MDRD) Formula
Blood samples were collected for the measurement of serum creatinine. Serum creatinine values were used to calculate eGFR using the MDRD formula, eGFR=175 x (serum creatinine)\^-1.154 x (Age)\^-0.203 x (0.742 if female) x (1.212 if African American). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. Change from Baseline in eGFR using Baseline data from Local or Central Laboratory, and post-Baseline Central Laboratory data for the on-treatment time period is presented.
Time frame: Baseline and Months 8 and 16
Population: Safety Population. Only those participants with a value at Baseline and specified visit were analyzed (represented by n=X in category titles)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Estimated Glomerular Filtration Rate (eGFR) Calculated Using Modification of Diet in Renal Disease (MDRD) Formula | Month 8; n=3977,4008 | 1.22 Milliliter/minute/1.73 meter square | Standard Error 0.264 |
| Placebo | Change in Estimated Glomerular Filtration Rate (eGFR) Calculated Using Modification of Diet in Renal Disease (MDRD) Formula | Month 16; n=2354,2496 | -0.90 Milliliter/minute/1.73 meter square | Standard Error 0.303 |
| Albiglutide | Change in Estimated Glomerular Filtration Rate (eGFR) Calculated Using Modification of Diet in Renal Disease (MDRD) Formula | Month 8; n=3977,4008 | 0.10 Milliliter/minute/1.73 meter square | Standard Error 0.262 |
| Albiglutide | Change in Estimated Glomerular Filtration Rate (eGFR) Calculated Using Modification of Diet in Renal Disease (MDRD) Formula | Month 16; n=2354,2496 | -1.33 Milliliter/minute/1.73 meter square | Standard Error 0.296 |
p-value: 0.00395% CI: [-1.84, -0.39]t-test, 2 sided
p-value: 0.31595% CI: [-1.26, 0.41]t-test, 2 sided
Secondary
Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Investigational Product (AELD)
The number of participants with on-therapy AEs leading to discontinuation of investigational product is reported.
Time frame: Up to 2.7 years
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Investigational Product (AELD) | 334 Participants |
| Albiglutide | Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Investigational Product (AELD) | 427 Participants |
Secondary
Number of Participants With AEs of Special Interest
The protocol defined AEs of special interest included: development of thyroid cancer; hematologic malignancy; pancreatic cancer; pancreatitis (investigator reported and pancreatitis positively adjudicated by the Pancreatic Adjudication Committee \[PAC\]); investigational product injection site reactions; immunological reactions; severe hypoglycemic events; hepatic events; hepatic enzyme elevations (including gamma glutamyl transferase \[GGT\]); serious gastrointestinal (GI) events; appendicitis; atrial fibrillation/flutter; pneumonia; worsening renal function and diabetic retinopathy. The number of participants with on-therapy AEs of special interest is reported.
Time frame: Up to 2.7 years
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With AEs of Special Interest | Thyroid cancer diagnosis | 0 Participants |
| Placebo | Number of Participants With AEs of Special Interest | Hematologic malignancy | 5 Participants |
| Placebo | Number of Participants With AEs of Special Interest | Pancreatic cancer | 5 Participants |
| Placebo | Number of Participants With AEs of Special Interest | Investigational product injection site reaction | 29 Participants |
| Placebo | Number of Participants With AEs of Special Interest | Hypersensitivity | 48 Participants |
| Placebo | Number of Participants With AEs of Special Interest | Severe hypoglycemic events | 55 Participants |
| Placebo | Number of Participants With AEs of Special Interest | Hepatic events | 74 Participants |
| Placebo | Number of Participants With AEs of Special Interest | Hepatic enzyme elevations (including GGT) | 34 Participants |
| Placebo | Number of Participants With AEs of Special Interest | Serious GI Events | 87 Participants |
| Placebo | Number of Participants With AEs of Special Interest | Appendicitis | 8 Participants |
| Placebo | Number of Participants With AEs of Special Interest | Atrial fibrillation/atrial flutter | 131 Participants |
| Placebo | Number of Participants With AEs of Special Interest | Pneumonia | 138 Participants |
| Placebo | Number of Participants With AEs of Special Interest | Renal impairment | 319 Participants |
| Placebo | Number of Participants With AEs of Special Interest | Diabetic retinopathy | 89 Participants |
| Placebo | Number of Participants With AEs of Special Interest | Investigator-reported pancreatitis | 13 Participants |
| Placebo | Number of Participants With AEs of Special Interest | Pancreatitis positively adjudicated by PAC | 7 Participants |
| Albiglutide | Number of Participants With AEs of Special Interest | Pancreatitis positively adjudicated by PAC | 10 Participants |
| Albiglutide | Number of Participants With AEs of Special Interest | Thyroid cancer diagnosis | 0 Participants |
| Albiglutide | Number of Participants With AEs of Special Interest | Serious GI Events | 92 Participants |
| Albiglutide | Number of Participants With AEs of Special Interest | Hematologic malignancy | 9 Participants |
| Albiglutide | Number of Participants With AEs of Special Interest | Renal impairment | 279 Participants |
| Albiglutide | Number of Participants With AEs of Special Interest | Pancreatic cancer | 6 Participants |
| Albiglutide | Number of Participants With AEs of Special Interest | Appendicitis | 3 Participants |
| Albiglutide | Number of Participants With AEs of Special Interest | Investigational product injection site reaction | 86 Participants |
| Albiglutide | Number of Participants With AEs of Special Interest | Investigator-reported pancreatitis | 14 Participants |
| Albiglutide | Number of Participants With AEs of Special Interest | Severe hypoglycemic events | 31 Participants |
| Albiglutide | Number of Participants With AEs of Special Interest | Hypersensitivity | 45 Participants |
| Albiglutide | Number of Participants With AEs of Special Interest | Atrial fibrillation/atrial flutter | 108 Participants |
| Albiglutide | Number of Participants With AEs of Special Interest | Diabetic retinopathy | 78 Participants |
| Albiglutide | Number of Participants With AEs of Special Interest | Hepatic events | 98 Participants |
| Albiglutide | Number of Participants With AEs of Special Interest | Pneumonia | 131 Participants |
| Albiglutide | Number of Participants With AEs of Special Interest | Hepatic enzyme elevations (including GGT) | 51 Participants |
Secondary
Number of Participants With Non-fatal Serious Adverse Events (SAEs)
SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before; is associated with liver injury and impaired liver function. Number of participants with on-therapy non-fatal SAEs are presented. Safety Population comprised of all randomized participants who received at least one dose of study treatment.
Time frame: Up to 2.7 years
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Non-fatal Serious Adverse Events (SAEs) | 974 Participants |
| Albiglutide | Number of Participants With Non-fatal Serious Adverse Events (SAEs) | 891 Participants |
Secondary
Percentage of Participants Achieving Composite Metabolic Endpoint
Percentage of participants achieving composite metabolic endpoint defined as the percentage of participants achieving glycemic control (glycated hemoglobin \[HbA1c\] \<=7% ) with no severe hypoglycemic incidents and weight gain \< 5%. Final Assessment is the latest post-Baseline assessment of both HbA1c and weight.
Time frame: Months 8, 16, 24 and final assessment (up to 2.7 years)
Population: ITT Population. Only those participants with HbA1c and weight values at Baseline and at the specified visits were analyzed (represented by n=X in category titles)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Composite Metabolic Endpoint | Month 8, n=4127, 4195 | 15.4 Percentage of participants |
| Placebo | Percentage of Participants Achieving Composite Metabolic Endpoint | Month 16, n=3026, 3118 | 16.5 Percentage of participants |
| Placebo | Percentage of Participants Achieving Composite Metabolic Endpoint | Final assessment, n=4401, 4455 | 15.1 Percentage of participants |
| Placebo | Percentage of Participants Achieving Composite Metabolic Endpoint | Month 24, n=1119, 1173 | 17.8 Percentage of participants |
| Albiglutide | Percentage of Participants Achieving Composite Metabolic Endpoint | Month 24, n=1119, 1173 | 28.6 Percentage of participants |
| Albiglutide | Percentage of Participants Achieving Composite Metabolic Endpoint | Month 8, n=4127, 4195 | 32.2 Percentage of participants |
| Albiglutide | Percentage of Participants Achieving Composite Metabolic Endpoint | Final assessment, n=4401, 4455 | 26.0 Percentage of participants |
| Albiglutide | Percentage of Participants Achieving Composite Metabolic Endpoint | Month 16, n=3026, 3118 | 28.7 Percentage of participants |
p-value: <0.001Mantel Haenszel
p-value: <0.001Mantel Haenszel
p-value: <0.001Mantel Haenszel
p-value: <0.001Mantel Haenszel
Secondary
Time to Adjudicated CV Death
Time to adjudicated CV death was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
Time frame: Median of 1.65 person years for the CV follow-up time period
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Time to Adjudicated CV Death | 1.72 Events per 100 person years |
| Albiglutide | Time to Adjudicated CV Death | 1.61 Events per 100 person years |
p-value: 0.57895% CI: [0.73, 1.19]Wald statistic
Secondary
Time to Death
Time to death was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants who died/endpoint person-years) is presented along with 95% confidence interval. Endpoint person-years=(cumulative total time to event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the Vital Status follow-up time period.
Time frame: Median of 1.73 years for the Vital Status follow-up time period
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Time to Death | 2.56 Events per 100 person years |
| Albiglutide | Time to Death | 2.44 Events per 100 person years |
p-value: 0.64495% CI: [0.79, 1.16]Wald test
Secondary
Time to First Occurrence of a Clinically Important Microvascular Event
Clinically important microvascular events were defined as the following: need for renal transplant or dialysis, new diabetes-related blindness, and procedures (laser photocoagulation or anti-vascular endothelial growth factor treatment or vitrectomy for diabetic retinopathy/eye disease). Time to first occurrence of a clinically important microvascular event was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period.
Time frame: Up to 2.7 years
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Time to First Occurrence of a Clinically Important Microvascular Event | 0.69 Events per 100 person years |
| Albiglutide | Time to First Occurrence of a Clinically Important Microvascular Event | 0.46 Events per 100 person years |
p-value: 0.05595% CI: [0.43, 1.01]Wald test
Secondary
Time to First Occurrence of Adjudicated CV Death or Hospitalization for Heart Failure (HF)
Time to first occurrence of adjudicated CV death or hospitalization for HF was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
Time frame: Median of 1.65 person years for CV follow-up time period
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Time to First Occurrence of Adjudicated CV Death or Hospitalization for Heart Failure (HF) | 2.92 Events per 100 person years |
| Albiglutide | Time to First Occurrence of Adjudicated CV Death or Hospitalization for Heart Failure (HF) | 2.49 Events per 100 person years |
p-value: 0.11395% CI: [0.7, 1.04]Wald statistic
Secondary
Time to First Occurrence of Adjudicated MI
Time to first occurrence of adjudicated MI was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
Time frame: Median of 1.65 person years for CV follow-up time period
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Time to First Occurrence of Adjudicated MI | 3.26 Events per 100 person years |
| Albiglutide | Time to First Occurrence of Adjudicated MI | 2.43 Events per 100 person years |
p-value: 0.00395% CI: [0.61, 0.9]Wald statistic
Secondary
Time to First Occurrence of Adjudicated Stroke
Time to first occurrence of adjudicated stroke was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
Time frame: Median of 1.65 person years for CV follow-up time period
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Time to First Occurrence of Adjudicated Stroke | 1.45 Events per 100 person years |
| Albiglutide | Time to First Occurrence of Adjudicated Stroke | 1.25 Events per 100 person years |
p-value: 0.395% CI: [0.66, 1.14]Wald statistic
Secondary
Time to First Occurrence of MACE or Urgent Revascularization for Unstable Angina
Time to first occurrence of CEC-adjudicated MACE (CV death, MI or stroke) or urgent revascularization for unstable angina was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
Time frame: Median of 1.65 person years for CV follow-up time period
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Time to First Occurrence of MACE or Urgent Revascularization for Unstable Angina | 6.45 Events per 100 person years |
| Albiglutide | Time to First Occurrence of MACE or Urgent Revascularization for Unstable Angina | 5.06 Events per 100 person years |
p-value: <0.00195% CI: [0.69, 0.9]Wald statistic
Secondary
Time to Initiation of Insulin of More Than 3 Months Duration for Those Participants Not Treated With Insulin at Study Start
Time to initiation of insulin of more than 3 months duration in participants not treated with insulin at study start was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period. The analysis was performed on Non-Insulin Population which comprised of participants in the ITT Population who were not on insulin at Baseline.
Time frame: Up to 2.7 years
Population: Non-Insulin Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Time to Initiation of Insulin of More Than 3 Months Duration for Those Participants Not Treated With Insulin at Study Start | 8.58 Events per 100 person years |
| Albiglutide | Time to Initiation of Insulin of More Than 3 Months Duration for Those Participants Not Treated With Insulin at Study Start | 3.56 Events per 100 person years |
p-value: <0.00195% CI: [0.33, 0.53]Wald test
Secondary
Time to Initiation of Prandial Insulin in Those Participants on Basal Insulin at Study Start
Time to initiation of prandial insulin in those participants on basal insulin at study start was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period. The analysis was performed on Basal Insulin Population which comprised of participants in the ITT Population who were on basal insulin but not on other insulin at Baseline (i.e., will not include a participant on a mixed insulin or on a prandial-only insulin).
Time frame: Up to 2.7 years
Population: Basal Insulin Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Time to Initiation of Prandial Insulin in Those Participants on Basal Insulin at Study Start | 5.09 Events per 100 person years |
| Albiglutide | Time to Initiation of Prandial Insulin in Those Participants on Basal Insulin at Study Start | 3.59 Events per 100 person years |
p-value: 0.04395% CI: [0.51, 0.99]Wald test