Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albiglutide + Sulfonylurea | Active Comparator | Albiglutide in combination with background sulfonylurea |
|
| Albiglutide + Biguanide | Active Comparator | Albiglutide in combination with background biguanide |
|
| Albiglutide + Glinide | Active Comparator | Albiglutide in combination with background glinide |
|
| Albiglutide + Thiazolidinedione | Active Comparator | Albiglutide in combination with background thiazolidinedione |
|
| Albiglutide + Alpha-glucosidase inhibitor | Active Comparator | Albiglutide in combination with background alpha-glucosidase inhibitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albiglutide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Baseline through Week 52 |
| 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. | From Baseline through Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aichi | 456-0058 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27852119 | Derived | Okuda I, Wilson TH, Yue L, Nakajima H, Carr MC, Tsuboi M, Nino A, Seino Y. Albiglutide, a weekly GLP-1 receptor agonist, improves glycemic parameters in Japanese patients with type 2 diabetes over 1 year when added to single oral antidiabetic drugs. Curr Med Res Opin. 2017 Mar;33(3):431-438. doi: 10.1080/03007995.2016.1261817. Epub 2016 Dec 21. |
| 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 |
|---|---|---|---|
| 116170 | 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.
Not provided
Not provided
Not provided
Not provided
Eligible participants entered a 2-week Screening Period; a 52-week Treatment Period and an 8-week Follow-up (FU) Period.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Albiglutide Plus (+) Background OAD (Biguanide) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sulfonylurea | Drug | Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed. |
|
| Biguanide | Drug | Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed. |
|
| Glinide | Drug | Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed. |
|
| Thiazolidinedione | Drug | Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed. |
|
| Alpha-glucosidase inhibitor | Drug | Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed. |
|
| Baseline and Week 52 |
| 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%. | Week 52 |
| 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. | Baseline and Week 52 |
| 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. | Baseline and Week 52 |
| 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 |
| Chiba |
| 263-0043 |
| Japan |
| GSK Investigational Site | Ehime | 792-8586 | Japan |
| GSK Investigational Site | Fukuoka | 810-0014 | Japan |
| GSK Investigational Site | Fukuoka | 815-8588 | Japan |
| GSK Investigational Site | Fukuoka | 819-0168 | Japan |
| GSK Investigational Site | Fukushima | 960-0418 | Japan |
| GSK Investigational Site | Fukushima | 963-8851 | Japan |
| GSK Investigational Site | Gunma | 370-3573 | Japan |
| GSK Investigational Site | Gunma | 379-0116 | Japan |
| GSK Investigational Site | Hokkaido | 040-8585 | Japan |
| GSK Investigational Site | Hokkaido | 070-0002 | Japan |
| GSK Investigational Site | Ibaraki | 300-0835 | Japan |
| GSK Investigational Site | Ibaraki | 311-0113 | Japan |
| GSK Investigational Site | Kagawa | 760-0076 | Japan |
| GSK Investigational Site | Kagoshima | 890-0061 | Japan |
| GSK Investigational Site | Kanagawa | 232-0064 | Japan |
| GSK Investigational Site | Kanagawa | 235-0045 | Japan |
| GSK Investigational Site | Kanagawa | 252-0302 | Japan |
| GSK Investigational Site | Kanagawa | 253-0044 | Japan |
| GSK Investigational Site | Kochi | 780-0088 | Japan |
| GSK Investigational Site | Kumamoto | 862-0960 | Japan |
| GSK Investigational Site | Kumamoto | 867-0041 | Japan |
| GSK Investigational Site | Kyoto | 600-8558 | Japan |
| GSK Investigational Site | Kyoto | 601-1495 | Japan |
| GSK Investigational Site | Kyoto | 601-8325 | Japan |
| GSK Investigational Site | Miyagi | 980-0021 | Japan |
| GSK Investigational Site | Miyagi | 985-0852 | Japan |
| GSK Investigational Site | Nagano | 399-0006 | Japan |
| GSK Investigational Site | Nagano | 399-0036 | Japan |
| GSK Investigational Site | Okinawa | 900-0029 | Japan |
| GSK Investigational Site | Osaka | 530-0012 | Japan |
| GSK Investigational Site | Osaka | 536-0023 | Japan |
| GSK Investigational Site | Osaka | 538-0044 | Japan |
| GSK Investigational Site | Osaka | 577-0803 | Japan |
| GSK Investigational Site | Osaka | 582-0019 | Japan |
| GSK Investigational Site | Ōita | 870-0039 | Japan |
| GSK Investigational Site | Saitama | 332-0012 | Japan |
| GSK Investigational Site | Saitama | 350-0035 | Japan |
| GSK Investigational Site | Saitama | 350-0851 | Japan |
| GSK Investigational Site | Saitama | 354-0031 | Japan |
| GSK Investigational Site | Saitama | 355-0321 | Japan |
| GSK Investigational Site | Saitama | 358-0011 | Japan |
| GSK Investigational Site | Shizuoka | 424-0855 | Japan |
| GSK Investigational Site | Tochigi | 329-0433 | Japan |
| GSK Investigational Site | Tokyo | 103-0002 | Japan |
| GSK Investigational Site | Tokyo | 103-0027 | Japan |
| GSK Investigational Site | Tokyo | 125-0054 | Japan |
| GSK Investigational Site | Tokyo | 143-0015 | Japan |
For additional information about this study please refer to the GSK Clinical Study Register |
| 116170 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116170 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116170 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116170 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116170 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| Completing Treatment Period |
|
| Completing Follow-up Period |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| 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 | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety Population: all participants who received at least 1 dose of study treatment. | Posted | Number | Participants | From Baseline through Week 52 |
|
|
| ||||||||||||||||||||||||||||||||||||||
| 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. | Safety Population: all participants who received at least 1 dose of study treatment. | Posted | Number | Participants | From Baseline through Week 52 |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | Percentage of HbA1c in the blood | Baseline and Week 52 |
| |||||||||||||||||||||||||||||||||||||||
| 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%. | Intent-to-Treat (Last Observation Carried Forward) Population | Posted | Number | Percentage of participants | Week 52 |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | Milligrams per deciliter (mg/dL) | Baseline and Week 52 |
| |||||||||||||||||||||||||||||||||||||||
| 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. | Intent-to-Treat (Last Observation Carried Forward) Population | Posted | Mean | Standard Deviation | Kilograms (kg) | Baseline and Week 52 |
| |||||||||||||||||||||||||||||||||||||||
| 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 \ | Intent-to-Treat (Last Observation Carried Forward) Population. Only participants who were withdrawn due to hyperglycemia were analyzed. | Posted | Mean | Standard Deviation | Weeks | Week 52 |
|
On-therapy non-serious adverse events (AEs) and serious adverse events (SAEs) with an onset date on or after the start date of study treatment and within 56 days after the date of the last dose of study treatment, are summarized through Week 52.
The non-serious AEs and SAEs are reported for the Safety Population, which comprised of all participants who received at least 1 dose of study treatment; par. underwent uptitration of albiglutide from 30 mg to 50 mg weekly based on glycemic parameters.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 2 | 120 | 68 | 120 | ||
| EG001 | 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. | 0 | 67 | 31 | 67 | ||
| EG002 | 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. | 1 | 65 | 38 | 65 | ||
| EG003 | 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. | 2 | 61 | 35 | 61 | ||
| EG004 | 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. | 3 | 61 | 24 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal abscess | Infections and infestations | MedDRA version 17.1 |
| ||
| Urinary tract infection | Infections and infestations | MedDRA version 17.1 |
| ||
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 |
| ||
| Foot fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 |
| ||
| Colon Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 |
| ||
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 |
| ||
| Chest discomfort | General disorders | MedDRA version 17.1 |
| ||
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 17.1 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA version 17.1 |
| ||
| Constipation | Gastrointestinal disorders | MedDRA version 17.1 |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 17.1 |
| ||
| Diabetic retinopathy | Eye disorders | MedDRA version 17.1 |
| ||
| Bronchitis | Infections and infestations | MedDRA version 17.1 |
| ||
| Pharyngitis | Infections and infestations | MedDRA version 17.1 |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.1 |
| ||
| Gastroenteritis | Infections and infestations | MedDRA version 17.1 |
| ||
| Contusion | Injury, poisoning and procedural complications | MedDRA version 17.1 |
|
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 |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| 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 |
| D013453 | Sulfonylurea Compounds |
| D001645 | Biguanides |
| C089946 | 2,4-thiazolidinedione |
| D065089 | Glycoside Hydrolase Inhibitors |
| ID | Term |
|---|---|
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D006146 | Guanidines |
| D000578 | Amidines |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |
Not provided
Not provided
| Male |
|
| Any SAE |
|
| OG003 | 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. |
| OG004 | 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. |
|
|
| 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG003 | 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. |
| OG004 | 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. |
|
|