Diabetes Mellitus
Conditions
Keywords
albiglutide, Japanese, glucagon-like peptide-1, GSK716155
Brief summary
This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus.
Detailed description
This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus. Subjects with a historical diagnosis of type 2 diabetes mellitus who are inadequately controlled on a single oral antidiabetic agent will be recruited into the study. Subjects will continue on their single antidiabetic agent and once weekly albiglutide will be added.
Interventions
DRUGAlbiglutide
Albiglutide is a fixed-dose, fully disposable pen injector system for delivery of albiglutide from a prefilled dual chamber glass cartridge that is an integral part of the pen. It is intended for single use by the subject. It is designed for manual reconstitution of the dose, priming, and insertion of the pen needle, and manual injection by the subject. The subject will inject albiglutide 30 mg weekly for 52 weeks (with optional uptitration to 50 mg weekly) subcutaneously into the abdomen, alternating between left and right sides. The pen is designed to work with standard pen needles.
DRUGSulfonylurea
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
DRUGBiguanide
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
DRUGGlinide
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with diagnosis of Type 2 Diabetes Mellitus, who are experiencing inadequate glycemic control and receiving treatment with a stable dose of a single oral antidiabetic medication * Body mass index (BMI) 17 to 40 kg/ m2 inclusive * Subjects with an HbA1c between 7.0% and 10.0% at Screening * Creatinine clearance \>30 mL/min (calculated using the Cockcroft-Gault formula)
Exclusion criteria
* History of type 1 diabetes mellitus * Female subject is pregnant, lactating, or \<6 weeks postpartum * Clinically significant cardiovascular and/or cerebrovascular disease * Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator * Serum amylase \>=3 ×ULN and/or serum lipase \>=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis * Prior use of a GLP-1R agonist or DPP-IV inhibitor within 6 months before Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | From Baseline through Week 52 | An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. Non-serious hypoglycemia events are not included. |
| Number of Participants With Any Hypoglycemic Event | From Baseline through Week 52 | Hypoglycemia events are defined with respect to low plasma glucose level, mostly accompanied by typical symptoms and/or assistance needed from third party with glucose administration. These events were reported by the investigators upon verification of the plasma glucose levels, symptoms and assistance recorded by the participants, and/or plasma glucose values obtained from laboratory evaluations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | Baseline and Week 52 | FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline FPG observation carried forward for the analysis. |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 | Baseline and Week 52 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis. |
| Time to Study Withdrawal Due to Hyperglycemia | Week 52 | Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose \>=280 mg/dL (\>=15.5 mmol/L) from \>=Week 2 to \<Week 12 or \>=230 mg/dL (\>=12.8 mmol/L) from \>=Week 12 to \<Week 52. |
| Change From Baseline in Body Weight at Week 52 | Baseline and Week 52 | The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline weight observation carried forward for the analysis. |
| Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52) | Week 52 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis. Clinically meaningful levels of response in HbA1c are defined as \<6.5% and \<7.0%. |
Countries
Japan
Participant flow
Recruitment details
A total of 360 participants with type 2 diabetes mellitus (T2DM) were planned and 374 participants were enrolled and analyzed in the Safety Population; the Safety Population and Intent-to-Treat Population were identical in this study.
Pre-assignment details
Eligible participants entered a 2-week Screening Period; a 52-week Treatment Period and an 8-week Follow-up (FU) Period.
Participants by arm
| Arm | Count |
|---|---|
| Albiglutide Plus (+) Background OAD (Sulfonylurea) Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52. | 120 |
| Albiglutide Plus (+) Background OAD (Biguanide) Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52. | 67 |
| Albiglutide Plus (+) Background OAD (Glinide) Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52. | 65 |
| Albiglutide Plus (+) Background OAD (Thiazolidinedione) Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52. | 61 |
| Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor) Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52. | 61 |
| Total | 374 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 | 2 | 1 | 3 |
| Overall Study | Moved, transfer abroad, did not enter FU | 1 | 0 | 1 | 0 | 0 |
| Overall Study | New Antidiabetic Medication | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Persistent Hyperglycemia | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 2 | 0 | 1 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | Albiglutide Plus (+) Background OAD (Sulfonylurea) | Albiglutide Plus (+) Background OAD (Biguanide) | Albiglutide Plus (+) Background OAD (Glinide) | Albiglutide Plus (+) Background OAD (Thiazolidinedione) | Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 58.5 Years STANDARD_DEVIATION 9.19 | 57.0 Years STANDARD_DEVIATION 8.55 | 55.7 Years STANDARD_DEVIATION 11.07 | 59.0 Years STANDARD_DEVIATION 10.54 | 57.4 Years STANDARD_DEVIATION 10.47 | 57.7 Years STANDARD_DEVIATION 9.89 |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 120 Participants | 67 Participants | 65 Participants | 61 Participants | 61 Participants | 374 Participants |
| Sex: Female, Male Female | 33 Participants | 22 Participants | 22 Participants | 11 Participants | 20 Participants | 108 Participants |
| Sex: Female, Male Male | 87 Participants | 45 Participants | 43 Participants | 50 Participants | 41 Participants | 266 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 68 / 120 | 31 / 67 | 38 / 65 | 35 / 61 | 24 / 61 |
| serious Total, serious adverse events | 2 / 120 | 0 / 67 | 1 / 65 | 2 / 61 | 3 / 61 |
Outcome results
Primary
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. Non-serious hypoglycemia events are not included.
Time frame: From Baseline through Week 52
Population: Safety Population: all participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Albiglutide Plus (+) Background OAD (Sulfonylurea) | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any AE | 97 Participants |
| Albiglutide Plus (+) Background OAD (Sulfonylurea) | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any SAE | 2 Participants |
| Albiglutide Plus (+) Background OAD (Biguanide) | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any AE | 47 Participants |
| Albiglutide Plus (+) Background OAD (Biguanide) | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any SAE | 0 Participants |
| Albiglutide Plus (+) Background OAD (Glinide) | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any AE | 58 Participants |
| Albiglutide Plus (+) Background OAD (Glinide) | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any SAE | 1 Participants |
| Albiglutide Plus (+) Background OAD (Thiazolidinedione) | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any SAE | 2 Participants |
| Albiglutide Plus (+) Background OAD (Thiazolidinedione) | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any AE | 49 Participants |
| Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor) | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any AE | 43 Participants |
| Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor) | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any SAE | 3 Participants |
Primary
Number of Participants With Any Hypoglycemic Event
Hypoglycemia events are defined with respect to low plasma glucose level, mostly accompanied by typical symptoms and/or assistance needed from third party with glucose administration. These events were reported by the investigators upon verification of the plasma glucose levels, symptoms and assistance recorded by the participants, and/or plasma glucose values obtained from laboratory evaluations.
Time frame: From Baseline through Week 52
Population: Safety Population: all participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albiglutide Plus (+) Background OAD (Sulfonylurea) | Number of Participants With Any Hypoglycemic Event | 17 Participants |
| Albiglutide Plus (+) Background OAD (Biguanide) | Number of Participants With Any Hypoglycemic Event | 1 Participants |
| Albiglutide Plus (+) Background OAD (Glinide) | Number of Participants With Any Hypoglycemic Event | 4 Participants |
| Albiglutide Plus (+) Background OAD (Thiazolidinedione) | Number of Participants With Any Hypoglycemic Event | 2 Participants |
| Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor) | Number of Participants With Any Hypoglycemic Event | 0 Participants |
Secondary
Change From Baseline in Body Weight at Week 52
The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline weight observation carried forward for the analysis.
Time frame: Baseline and Week 52
Population: Intent-to-Treat (Last Observation Carried Forward) Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albiglutide Plus (+) Background OAD (Sulfonylurea) | Change From Baseline in Body Weight at Week 52 | 0.25 Kilograms (kg) | Standard Deviation 2.167 |
| Albiglutide Plus (+) Background OAD (Biguanide) | Change From Baseline in Body Weight at Week 52 | -0.33 Kilograms (kg) | Standard Deviation 2.082 |
| Albiglutide Plus (+) Background OAD (Glinide) | Change From Baseline in Body Weight at Week 52 | -0.04 Kilograms (kg) | Standard Deviation 2.405 |
| Albiglutide Plus (+) Background OAD (Thiazolidinedione) | Change From Baseline in Body Weight at Week 52 | 0.52 Kilograms (kg) | Standard Deviation 2.823 |
| Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor) | Change From Baseline in Body Weight at Week 52 | -0.13 Kilograms (kg) | Standard Deviation 2.62 |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline FPG observation carried forward for the analysis.
Time frame: Baseline and Week 52
Population: Intent-to-Treat (Last Observation Carried Forward) Population. Only those participants with valid post-Baseline results (within 14 days of last exposure to treatment) were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albiglutide Plus (+) Background OAD (Sulfonylurea) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | -16.4 Milligrams per deciliter (mg/dL) | Standard Deviation 28.52 |
| Albiglutide Plus (+) Background OAD (Biguanide) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | -24.3 Milligrams per deciliter (mg/dL) | Standard Deviation 19.98 |
| Albiglutide Plus (+) Background OAD (Glinide) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | -16.4 Milligrams per deciliter (mg/dL) | Standard Deviation 30.37 |
| Albiglutide Plus (+) Background OAD (Thiazolidinedione) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | -32.1 Milligrams per deciliter (mg/dL) | Standard Deviation 27.21 |
| Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | -33.2 Milligrams per deciliter (mg/dL) | Standard Deviation 28.38 |
Secondary
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis.
Time frame: Baseline and Week 52
Population: Intent-to-Treat (Last Observation Carried Forward) Population: all enrolled participants who received at least 1 dose of study medication and who had at least one HbA1c post-Baseline assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albiglutide Plus (+) Background OAD (Sulfonylurea) | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 | -1.04 Percentage of HbA1c in the blood | Standard Deviation 0.657 |
| Albiglutide Plus (+) Background OAD (Biguanide) | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 | -0.94 Percentage of HbA1c in the blood | Standard Deviation 0.623 |
| Albiglutide Plus (+) Background OAD (Glinide) | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 | -0.95 Percentage of HbA1c in the blood | Standard Deviation 0.836 |
| Albiglutide Plus (+) Background OAD (Thiazolidinedione) | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 | -1.42 Percentage of HbA1c in the blood | Standard Deviation 0.771 |
| Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor) | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 | -1.39 Percentage of HbA1c in the blood | Standard Deviation 0.77 |
Secondary
Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52)
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis. Clinically meaningful levels of response in HbA1c are defined as \<6.5% and \<7.0%.
Time frame: Week 52
Population: Intent-to-Treat (Last Observation Carried Forward) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Albiglutide Plus (+) Background OAD (Sulfonylurea) | Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52) | HbA1c <6.5% | 20.0 Percentage of participants |
| Albiglutide Plus (+) Background OAD (Sulfonylurea) | Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52) | HbA1c <7.0% | 54.2 Percentage of participants |
| Albiglutide Plus (+) Background OAD (Biguanide) | Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52) | HbA1c <6.5% | 26.9 Percentage of participants |
| Albiglutide Plus (+) Background OAD (Biguanide) | Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52) | HbA1c <7.0% | 59.7 Percentage of participants |
| Albiglutide Plus (+) Background OAD (Glinide) | Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52) | HbA1c <6.5% | 24.6 Percentage of participants |
| Albiglutide Plus (+) Background OAD (Glinide) | Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52) | HbA1c <7.0% | 52.3 Percentage of participants |
| Albiglutide Plus (+) Background OAD (Thiazolidinedione) | Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52) | HbA1c <7.0% | 80.3 Percentage of participants |
| Albiglutide Plus (+) Background OAD (Thiazolidinedione) | Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52) | HbA1c <6.5% | 45.9 Percentage of participants |
| Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor) | Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52) | HbA1c <6.5% | 26.2 Percentage of participants |
| Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor) | Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52) | HbA1c <7.0% | 67.2 Percentage of participants |
Secondary
Time to Study Withdrawal Due to Hyperglycemia
Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose \>=280 mg/dL (\>=15.5 mmol/L) from \>=Week 2 to \<Week 12 or \>=230 mg/dL (\>=12.8 mmol/L) from \>=Week 12 to \<Week 52.
Time frame: Week 52
Population: Intent-to-Treat (Last Observation Carried Forward) Population. Only participants who were withdrawn due to hyperglycemia were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albiglutide Plus (+) Background OAD (Sulfonylurea) | Time to Study Withdrawal Due to Hyperglycemia | 13.0 Weeks | — |
| Albiglutide Plus (+) Background OAD (Glinide) | Time to Study Withdrawal Due to Hyperglycemia | 16.5 Weeks | Standard Deviation 3.54 |