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This is a randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose ranging study evaluating the dose response, efficacy and safety of subcutaneously injected GSK716155 (albiglutide) in Japanese subjects with type 2 diabetes mellitus.
This is a Phase IIb, randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose ranging, superiority study evaluating the dose response, efficacy and safety of weekly and every other week subcutaneously injected GSK716155 (albiglutide) in subjects with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| albiglutide 15mg weekly | Active Comparator | once weekly subcutaneous injection of albiglutide 15mg |
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| albiglutide 30mg weekly | Active Comparator | once weekly subcutaneous injection of albiglutide 30mg |
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| albiglutide 30mg every other week | Active Comparator | subcutaneous injection of 30mg albiglutide every other week |
|
| placebo | Placebo Comparator | once weekly subcutaneous injection of placebo to match albiglutide |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albiglutide | Biological | subcutaneous injection of albiglutide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 | 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 16 minus the value at Baseline. Based on Analysis of Covariance (ANCOVA): Change = treatment + Baseline HbA1c + prior therapy. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Baseline and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at Weeks 4, 8, 12, and 16 | 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 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. |
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Inclusion Criteria:
Exclusion Criteria:
Diagnosis of type 1 diabetes mellitus
Uncorrected thyroid dysfunction
Previous use of insulin within one month prior to screening, or more than seven total days of insulin treatment within three months prior to screening
Clinically significantly cardiovascular and/or cerebrovascular disease including, but not limited to the following:
Heart rate: <40 and >110 bpm
PR interval: <120 and > 210 msec
QRS interval: <70 and >120 msec
QTc interval (Bazett): >450 msec or >480 msec with bundle branch block
Fasting triglyceride level >400 mg/dL at Screening
AST or ALT >2xULN, ALP and bilirubin >1.5xULN (except known Gilbert's syndrome and a fractionated bilirubin that shows conjugated bilirubin <35% of total bilirubin)
If female, is currently lactating, within 6 weeks post-partum, pregnant, or actively trying to become pregnant
Has significant renal disease as manifested by one or more of the following:
A hemoglobinopathy that may affect determination of HbA1c level
History of treated diabetic gastroparesis
History of significant gastrointestinal surgery, including gastric bypass and banding, or surgeries thought to significantly affect upper gastrointestinal function
Current ongoing symptomatic biliary disease or history of acute/chronic pancreatitis.
Lipase and amylase at Screening > ULN
Severe diabetic neuropathy, preproliferative retinopathy or proliferative retinopathy, history of ketoacidosis or hyperosmolar coma
History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 3 years before Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed)
Acute or chronic history of liver disease, positive hepatitis B surface antigen (HBsAg) or positive hepatitis C testing at Screening
Current and history of alcohol or substance abuse
Clinically significant anaemia or any other abnormal haematological profile that is considered by the investigator to be clinically significant
Prior use of a GLP-1 analog
Known allergy to any formulation excipients, or Baker's yeast, or history of drug, or other allergy which, in the opinion of the responsible study physician, contradicts participation
History of or family history of medullary carcinoma of the thyroid.
History of or family history of multiple endocrine neoplasia type 2
Receipt of any investigational drug within the 12 weeks before Screening
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aichi | 466-0815 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25387217 | Derived | Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836. | |
| 24552155 | Derived | Seino Y, Inagaki N, Miyahara H, Okuda I, Bush M, Ye J, Holland MC, Johnson S, Lewis E, Nakajima H. A randomized dose-finding study demonstrating the efficacy and tolerability of albiglutide in Japanese patients with type 2 diabetes mellitus. Curr Med Res Opin. 2014 Jun;30(6):1095-106. doi: 10.1185/03007995.2014.896327. Epub 2014 Mar 11. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 110932 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Participants (par.) who met eligibility criteria and completed a 4- to 8-week Run-in Period were then randomized to a 16-week Treatment Period, followed by an 8-week Follow-up Period. A total of 215 participants were randomized, and 212 received >=1 treatment dose.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period (TP) (16 Weeks) |
|
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| placebo | Biological | subcutaneous injection of placebo to match albiglutide |
|
| Baseline; Week 4, Week 8, Week 12, and Week 16 |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, and 16 | The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline; Week 4, Week 8, Week 12, and Week 16 |
| Change From Baseline in Body Weight at Week 4, 8, 12, and 16 | The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. | Baseline; Week 4, Week 8, Week 12, and Week 16 |
| Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7% at Weeks 4, 8, 12, and 16 | The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5% and <7%) were assessed. | Week 4, Week 8, Week 12, and Week 16 |
| Mean Clearance of Albiglutide | Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, pharmacokinetic (PK) samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK. | Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24 |
| Mean Volume of Distribution of Albiglutide | Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK. | Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24 |
| Mean Absorption Rate of Albiglutide | Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK. | Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24 |
| Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG | EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model. | Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24 |
| Ehime |
| 790-0067 |
| Japan |
| GSK Investigational Site | Fukuoka | 810-0001 | Japan |
| GSK Investigational Site | Fukuoka | 811-1346 | Japan |
| GSK Investigational Site | Fukuoka | 815-8555 | Japan |
| GSK Investigational Site | Fukuoka | 819-0168 | Japan |
| GSK Investigational Site | Hiroshima | 731-0103 | Japan |
| GSK Investigational Site | Hokkaido | 003-0023 | Japan |
| GSK Investigational Site | Hokkaido | 044-0053 | Japan |
| GSK Investigational Site | Hokkaido | 061-1395 | Japan |
| GSK Investigational Site | Hokkaido | 080-0010 | Japan |
| GSK Investigational Site | Hokkaido | 080-0016 | Japan |
| GSK Investigational Site | Ibaraki | 310-0826 | Japan |
| GSK Investigational Site | Ibaraki | 311-0113 | Japan |
| GSK Investigational Site | Kagoshima | 891-0401 | Japan |
| GSK Investigational Site | Kanagawa | 210-0852 | Japan |
| GSK Investigational Site | Kanagawa | 235-0045 | Japan |
| GSK Investigational Site | Kumamoto | 862-0976 | Japan |
| GSK Investigational Site | Kumamoto | 866-0862 | Japan |
| GSK Investigational Site | Miyagi | 980-0021 | Japan |
| GSK Investigational Site | Miyagi | 985-0852 | Japan |
| GSK Investigational Site | Nagasaki | 856-0831 | Japan |
| GSK Investigational Site | Saitama | 355-0321 | Japan |
| GSK Investigational Site | Saitama | 362-0021 | Japan |
| GSK Investigational Site | Tochigi | 329-0101 | Japan |
| GSK Investigational Site | Tochigi | 329-0433 | Japan |
| GSK Investigational Site | Tokyo | 125-0054 | Japan |
| GSK Investigational Site | Tokyo | 154-0015 | Japan |
| GSK Investigational Site | Tokyo | 177-0041 | Japan |
| GSK Investigational Site | Yamagata | 990-0885 | Japan |
For additional information about this study please refer to the GSK Clinical Study Register |
| 110932 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110932 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110932 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110932 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110932 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110932 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Albiglutide 15 mg Weekly |
Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. |
| FG002 | Albiglutide 30 mg Weekly | Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. |
| FG003 | Albiglutide 30 mg Every Other Week | Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. |
| COMPLETED |
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| NOT COMPLETED |
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| Follow-up (FU) Period (8 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. |
| BG001 | Albiglutide 15 mg Weekly | Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. |
| BG002 | Albiglutide 30 mg Weekly | Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. |
| BG003 | Albiglutide 30 mg Every Other Week | Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Baseline data are reported for members of the Safety Population, comprised of all enrolled participants who received at least one dose of study treatment. Participants were analyzed according to treatment received. | Mean | Standard Deviation | Years |
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| Gender | Baseline data are reported for members of the Safety Population, comprised of all enrolled participants who received at least one dose of study treatment. Participants were analyzed according to treatment received. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Baseline data are reported for members of the Safety Population, comprised of all enrolled participants who received at least one dose of study treatment. Participants were analyzed according to treatment received. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 | 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 16 minus the value at Baseline. Based on Analysis of Covariance (ANCOVA): Change = treatment + Baseline HbA1c + prior therapy. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Intent-to-Treat (ITT) Population: all randomized participants with at least one post-Baseline assessment of the primary endpoint, HbA1c. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c in the blood | Baseline and Week 16 |
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| Secondary | Change From Baseline in HbA1c at Weeks 4, 8, 12, and 16 | 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 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16. | Posted | Mean | Standard Deviation | Percentage of HbA1c in the blood | Baseline; Week 4, Week 8, Week 12, and Week 16 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, and 16 | The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16. | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Baseline; Week 4, Week 8, Week 12, and Week 16 |
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| Secondary | Change From Baseline in Body Weight at Week 4, 8, 12, and 16 | The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. | ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16. | Posted | Mean | Standard Deviation | Kilograms | Baseline; Week 4, Week 8, Week 12, and Week 16 |
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| Secondary | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7% at Weeks 4, 8, 12, and 16 | The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5% and <7%) were assessed. | ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16. | Posted | Number | Participants | Week 4, Week 8, Week 12, and Week 16 |
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| Secondary | Mean Clearance of Albiglutide | Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, pharmacokinetic (PK) samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK. | PK Analysis Population: all participants for whom a PK sample was obtained and analyzed | Posted | Mean | 95% Confidence Interval | milliliters per hour | Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24 |
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| Secondary | Mean Volume of Distribution of Albiglutide | Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK. | PK Analysis Population | Posted | Mean | 95% Confidence Interval | Liters | Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24 |
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| Secondary | Mean Absorption Rate of Albiglutide | Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK. | PK Analysis Population (Pop) | Posted | Mean | 95% Confidence Interval | hour^-1 | Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24 |
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| Secondary | Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG | EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model. | PK/PD Analysis Pop: all participants in the PK Analysis Pop with sufficient dosing history for inclusion in the PK/PD analysis. Modeled population PK data (analyzed using a non-linear mixed effect modeling approach) are presented. A one-compartment PK model with first-order absorption/elimination processes was selected to describe GSK716155 PK. | Posted | Mean | 95% Confidence Interval | nanograms per milliliter | Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24 |
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On-therapy serious adverse events (SAEs)/non-serious AEs, with a start date on/after the first day of study medication (SM) and within 56 days after the end of SM, were collected from the start of SM until Follow-up/Early Withdrawal (up to Study Day 168).
On-therapy SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all enrolled participants who received at least one dose of study treatment. Participants were analyzed according to treatment received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. | 2 | 53 | 21 | 53 | ||
| EG001 | Albiglutide 15 mg Weekly | Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. | 1 | 52 | 27 | 52 | ||
| EG002 | Albiglutide 30 mg Weekly | Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. | 2 | 54 | 20 | 54 | ||
| EG003 | Albiglutide 30 mg Every Other Week | Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. | 2 | 53 | 23 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C534611 | rGLP-1 protein |
Not provided
Not provided
Not provided
| Transferred to Oita (Japan) |
|
| Follow-up Not Conducted Due to Earthquak |
|
| Male |
|
| t-test, 2 sided |
| <0.0001 |
| Mean Difference (Final Values) |
| -1.55 |
| 2-Sided |
| 95 |
| -1.88 |
| -1.23 |
| Yes |
| Non-Inferiority or Equivalence |
The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons. |
| t-test, 2 sided | <0.0001 | Mean Difference (Final Values) | -1.10 | 2-Sided | 95 | -1.43 | -0.78 | Yes | Non-Inferiority or Equivalence | The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons. |
| OG002 | Albiglutide 30 mg Weekly | Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. |
| OG003 | Albiglutide 30 mg Every Other Week | Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. |
|
|
| OG002 | Albiglutide 30 mg Weekly | Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. |
| OG003 | Albiglutide 30 mg Every Other Week | Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. |
|
|
Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. |
| OG003 | Albiglutide 30 mg Every Other Week | Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. |
|
|
Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion.
| OG003 | Albiglutide 30 mg Every Other Week | Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator's discretion. |
|
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|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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|