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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus

Treatments

Drug: Biguanide
Drug: Glinide
Drug: Albiglutide
Drug: Thiazolidinedione
Drug: Alpha-glucosidase inhibitor
Drug: Sulfonylurea

Study type

Interventional

Funder types

Industry

Identifiers

NCT01777282
116170

Details and patient eligibility

About

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.

Full 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.

Enrollment

374 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

374 participants in 5 patient groups

Albiglutide + Sulfonylurea
Active Comparator group
Description:
Albiglutide in combination with background sulfonylurea
Treatment:
Drug: Sulfonylurea
Drug: Albiglutide
Albiglutide + Biguanide
Active Comparator group
Description:
Albiglutide in combination with background biguanide
Treatment:
Drug: Albiglutide
Drug: Biguanide
Albiglutide + Glinide
Active Comparator group
Description:
Albiglutide in combination with background glinide
Treatment:
Drug: Albiglutide
Drug: Glinide
Albiglutide + Thiazolidinedione
Active Comparator group
Description:
Albiglutide in combination with background thiazolidinedione
Treatment:
Drug: Thiazolidinedione
Drug: Albiglutide
Albiglutide + Alpha-glucosidase inhibitor
Active Comparator group
Description:
Albiglutide in combination with background alpha-glucosidase inhibitor
Treatment:
Drug: Alpha-glucosidase inhibitor
Drug: Albiglutide

Trial contacts and locations

49

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems