Text Size

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

This study is currently recruiting participants.
Verified February 2013 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01777282
First received: January 24, 2013
Last updated: May 9, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
 Drug: Albiglutide + SU
Drug: Albiglutide + biguanide
Drug: Albiglutide + glinide
Drug: Albiglutide + TZD
Drug: Albiglutide + alpha-glucosidase inhibitor
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Incidence of AEs and hypoglycemic events [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Long term safety and tolerability


Secondary Outcome Measures:
  • Change from Baseline at Week 52 of glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
    The HbA1c will be assessed to compare HbA1c change from baseline at Week 52

  • The proportion of subjects at HbA1c goals of </=6.5% and </=7.0% over time [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
    The proportion of subjects at HbA1c </=6.5% and </=7.0% through Week 52 to compare albiglutide in combination with various single oral antidiabetic agents

  • Change from Baseline in FPG over time [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
    FPG will be assessed comparing albiglutide in combination with various single oral antidibetic agents

  • Change from baseline in body weight over time [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
    Body weight will be assessed through Week 52 comparing albiglutide in combination with various single oral antidibetic agents

  • Percent of subjects withdrawn from randomly assigned treatment due to hyperglycemia over time [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
    The percent of subjects withdrawn due to hyperglycemia from each arm of the study will be assessed through Week 52


Estimated Enrollment: 360
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Albiglutide + SU
Albiglutide in combination with background SU
 Drug: Albiglutide + SU
Albiglutide 30mg weekly with optional uptitration to 50mg weekly in combination with background SU
Active Comparator: Albiglutide + biguanide
Albiglutide in combination with background biguanide
 Drug: Albiglutide + biguanide
Albiglutide 30mg weekly with optional uptitration to 50mg weekly in combination with background biguanide
Active Comparator: Albiglutide + glinide
Albiglutide in combination with background glinide
 Drug: Albiglutide + glinide
Albiglutide 30mg weekly with optional uptitration to 50mg weekly in combination with background glinide
Active Comparator: Albiglutide + TZD
Albiglutide in combination with background TZD
 Drug: Albiglutide + TZD
Albiglutide 30mg weekly with optional uptitration to 50mg weekly in combination with background TZD
Active Comparator: Albiglutide + alpha-glucosidase inhibitor
Albiglutide in combination with background alpha-glucosidase inhibitor
 Drug: Albiglutide + alpha-glucosidase inhibitor
Albiglutide 30mg weekly with optional uptitration to 50mg weekly in combination with background alpha-glucosidase inhibitor

Detailed 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. 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777282

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Japan
GSK Investigational Site Recruiting
Gunma, Japan, 370-3573
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
GSK Investigational Site Not yet recruiting
Tochigi, Japan, 329-0433
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
GSK Investigational Site Not yet recruiting
Tokyo, Japan, 103-0027
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01777282     History of Changes
Other Study ID Numbers: 116170
Study First Received: January 24, 2013
Last Updated: May 9, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by GlaxoSmithKline:
albiglutide
Japanese
glucagon-like peptide-1
GSK716155

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013