Dose Ranging Study of Albiglutide in Japanese Subjects

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01098461
First received: February 12, 2010
Last updated: February 16, 2012
Last verified: October 2011

February 12, 2010
February 16, 2012
April 2010
May 2011   (final data collection date for primary outcome measure)
Change from baseline in HbA1c [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01098461 on ClinicalTrials.gov Archive Site
  • Change from baseline in HbA1c over time [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Fasting Plasma Glucose (FPG) over time [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in body weight over time [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve HbA1c treatment goal [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic levels of albiglutide [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dose Ranging Study of Albiglutide in Japanese Subjects
Study GLP110932, A Dose Finding Study of GSK716155 (Albiglutide) Versus Placebo in the Treatment of Type 2 Diabetes Mellitus

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Biological: albiglutide
    subcutaneous injection of albiglutide
    Other Names:
    • placebo
    • albiglutide 30mg weekly
    • albiglutide 15mg weekly
    • albiglutide 30mg every other week
  • Biological: placebo
    subcutaneous injection of placebo to match albiglutide
  • Active Comparator: albiglutide 15mg weekly
    once weekly subcutaneous injection of albiglutide 15mg
    Intervention: Biological: albiglutide
  • Active Comparator: albiglutide 30mg weekly
    once weekly subcutaneous injection of albiglutide 30mg
    Intervention: Biological: albiglutide
  • Active Comparator: albiglutide 30mg every other week
    subcutaneous injection of 30mg albiglutide every other week
    Intervention: Biological: albiglutide
  • Placebo Comparator: placebo
    once weekly subcutaneous injection of placebo to match albiglutide
    Intervention: Biological: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
215
May 2011
May 2011   (final data collection date for primary outcome measure)

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
  • Clinically significantly cardiovascular and/or cerebrovascular disease including, but not limited to the following:

    • 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
  • Has significant renal disease as manifested by one or more of the following:

    • 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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01098461
110932
Yes
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP