Last updated: 11/07/2018 03:08:55
Dose ranging study of albiglutide in Japanese subjects
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Dose Finding Study of GSK716155 versus Placebo in the Treatment of Type 2 Diabetes Mellitus
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in glycosylated hemoglobin (HbA1c) at Week 16
Timeframe: Baseline and Week 16
Secondary outcomes:
Change from Baseline in HbA1c at Weeks 4, 8, 12, and 16
Timeframe: 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
Timeframe: Baseline; Week 4, Week 8, Week 12, and Week 16
Change from Baseline in body weight at Week 4, 8, 12, and 16
Timeframe: 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
Timeframe: Week 4, Week 8, Week 12, and Week 16
Mean clearance of albiglutide
Timeframe: Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24
Mean volume of distribution of albiglutide
Timeframe: Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24
Mean absorption rate of albiglutide
Timeframe: Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24
Mean half-maximal effective concentration (EC50) of albiglutide for HbA1c and FPG
Timeframe: Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24
Interventions:
Biological/vaccine: albiglutide
Biological/vaccine: placebo
Enrollment:
215
Observational study model:
Not applicable
Primary completion date:
2011-11-05
Time perspective:
Not applicable
Clinical publications:
Yutaka Seino, Nobuya Inagaki, Hiromu Nakajima, Inaha Okuda, Hajime Miyahara, Mark Bush, June Ye, Claire Holland, Susan Johnson, Eric Lewis. A randomized dose-finding study demonstrating efficacy and tolerability of albiglutide in Japanese patients with type 2 diabetes mellitus .Curr Med Res Opin.2014;30(6):1096-1106
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
GSK
Study date(s)
April 2010 to May 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
20 - 75 years
Accepts healthy volunteers
No
- Subject with a historical diagnosis of type 2 diabetes mellitus who is currently treated with diet and exercise only or one OAD
- BMI ≥18 kg/m2 and <35 kg/m2 at Screening
- Diagnosis of type 1 diabetes mellitus
- Uncorrected thyroid dysfunction
Inclusion and exclusion criteria
Inclusion criteria:
- Subject with a historical diagnosis of type 2 diabetes mellitus who is currently treated with diet and exercise only or one OAD
- BMI ≥18 kg/m2 and <35 kg/m2 at Screening
- HbA1c between 7.0% and 10.0%, inclusive
- Fasting C-peptide ≥0.8 ng/mL (≥0.26 nmol/L)
- Female subjects of childbearing potential must be practicing adequate contraception .
- Able and willing to monitor his/her own blood glucose concentrations with a home glucose monitor.
- Able and willing to provide written informed consent
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
- Previous history of stroke or transient ischemic attack
- Active, unstable coronary heart disease within the past six months before Screening
- Documented myocardial infarction within one year before Screening
- Any cardiac surgery including percutaneous transluminal coronary angioplasty, coronary stent placement, or coronary artery bypass graft surgery within one year before Screening
- Unstable angina
- Clinically significant arrhythmia or valvular heart disease
- Current heart failure NYHA class II to IV
- Resting systolic pressure >160 mm Hg or diastolic pressure >95 mm Hg at Screening
- ECG criteria at Screening
- 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
- Creatinine clearance at screening <60 mL/min (calculated by Cockcroft-Gault formula) at Screening
- Known loss of a kidney either by surgical ablation, injury or disease level
- 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
Clinically significantly cardiovascular and/or cerebrovascular disease including, but not limited to the following:
Has significant renal disease as manifested by one or more of the following:
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
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
2011-11-05
Actual study completion date
2011-11-05
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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