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

January 24, 2013
December 5, 2013
February 2013
February 2015   (final data collection date for primary outcome measure)
Incidence of AEs and hypoglycemic events [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Long term safety and tolerability
Same as current
Complete list of historical versions of study NCT01777282 on ClinicalTrials.gov Archive Site
  • 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  • Percent of subjects withdrawn from randomly assigned treatment due to hyperglycemia over time [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
    The percent of subjects withdrawn due to hyperglycemia from each arm of the study will be assessed through Week 52
Same as current
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
  • Drug: Albiglutide + SU
    Albiglutide 30mg weekly with optional uptitration to 50mg weekly in combination with background SU
  • Drug: Albiglutide + biguanide
    Albiglutide 30mg weekly with optional uptitration to 50mg weekly in combination with background biguanide
  • Drug: Albiglutide + glinide
    Albiglutide 30mg weekly with optional uptitration to 50mg weekly in combination with background glinide
  • Drug: Albiglutide + TZD
    Albiglutide 30mg weekly with optional uptitration to 50mg weekly in combination with background TZD
  • Drug: Albiglutide + alpha-glucosidase inhibitor
    Albiglutide 30mg weekly with optional uptitration to 50mg weekly in combination with background alpha-glucosidase inhibitor
  • Active Comparator: Albiglutide + SU
    Albiglutide in combination with background SU
    Intervention: Drug: Albiglutide + SU
  • Active Comparator: Albiglutide + biguanide
    Albiglutide in combination with background biguanide
    Intervention: Drug: Albiglutide + biguanide
  • Active Comparator: Albiglutide + glinide
    Albiglutide in combination with background glinide
    Intervention: Drug: Albiglutide + glinide
  • Active Comparator: Albiglutide + TZD
    Albiglutide in combination with background TZD
    Intervention: Drug: Albiglutide + TZD
  • Active Comparator: Albiglutide + alpha-glucosidase inhibitor
    Albiglutide in combination with background alpha-glucosidase inhibitor
    Intervention: Drug: Albiglutide + alpha-glucosidase inhibitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
360
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01777282
116170
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2013

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