Last updated: 11/07/2018 10:14:29
A Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination with Oral Monotherapy Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A 52-Week, Open-Label, Multicenter Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination with Monotherapy of Oral Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus
Trial 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of participants with any adverse event (AE) or any serious adverse event (SAE)
Timeframe: From Baseline through Week 52
Number of participants with any hypoglycemic event
Timeframe: From Baseline through Week 52
Secondary outcomes:
Change from Baseline in glycosylated hemoglobin (HbA1c) at Week 52
Timeframe: 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)
Timeframe: Week 52
Change from Baseline in fasting plasma glucose (FPG) at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in body weight at Week 52
Timeframe: Baseline and Week 52
Time to study withdrawal due to hyperglycemia
Timeframe: Week 52
Interventions:
Drug: Albiglutide
Drug: Sulfonylurea
Drug: Biguanide
Drug: Glinide
Drug: Thiazolidinedione
Drug: Alpha-glucosidase inhibitor
Enrollment:
374
Observational study model:
Not applicable
Primary completion date:
2015-27-01
Time perspective:
Not applicable
Clinical publications:
Inaha Okuda, Timothy Wilson, Lin Yue, Hiromu Nakajima, Molly C. Carr, Maho Tsuboi, Antonio Nino. ADA 2016: Albiglutide, a Weekly GLP-1 Agonist, Improved Glycemic Parameters in Japanese Type 2 Diabetes Mellitus (T2DM) Subjects Over 1 Year When Added to Single Oral Antihyperglycemic Medications. Diabetes.2016;65(1):A279.
Medical condition
Diabetes Mellitus
Product
albiglutide
Collaborators
Not applicable
Study date(s)
February 2013 to January 2015
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
No
- 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
- History of type 1 diabetes mellitus
- Female subject is pregnant, lactating, or <6 weeks postpartum
Inclusion and exclusion criteria
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
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2015-27-01
Actual study completion date
2015-27-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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