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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01777282
First received: January 24, 2013
Last updated: December 5, 2013
Last verified: November 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777282

Locations
Japan
GSK Investigational Site
Gunma, Japan, 370-3573
GSK Investigational Site
Tochigi, Japan, 329-0433
GSK Investigational Site
Tokyo, Japan, 103-0027
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: December 5, 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 July 20, 2014