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

Condition(s) targeted: Diabetes Mellitus

Intervention: Albiglutide + SU (Drug); Albiglutide + biguanide (Drug); Albiglutide + glinide (Drug); Albiglutide + TZD (Drug); Albiglutide + alpha-glucosidase inhibitor (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of AEs and hypoglycemic events

Secondary outcome:

Change from Baseline at Week 52 of glycosylated hemoglobin (HbA1c)

The proportion of subjects at HbA1c goals of Change from Baseline in FPG over time

Change from baseline in body weight over time

Percent of subjects withdrawn from randomly assigned treatment due to hyperglycemia over time

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.

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

GSK Investigational Site, Aichi 456-0058, Japan

GSK Investigational Site, Chiba 263-0043, Japan

GSK Investigational Site, Ehime 792-8586, Japan

GSK Investigational Site, Fukuoka 819-0168, Japan

GSK Investigational Site, Fukuoka 815-8588, Japan

GSK Investigational Site, Fukuoka 810-0014, Japan

GSK Investigational Site, Fukushima 960-0418, Japan

GSK Investigational Site, Fukushima 963-8851, Japan

GSK Investigational Site, Gunma 370-3573, Japan

GSK Investigational Site, Gunma 379-0116, Japan

GSK Investigational Site, Hokkaido 040-8585, Japan

GSK Investigational Site, Hokkaido 070-0002, Japan

GSK Investigational Site, Ibaraki 300-0835, Japan

GSK Investigational Site, Ibaraki 311-0113, Japan

GSK Investigational Site, Kagawa 760-0076, Japan

GSK Investigational Site, Kagoshima 890-0061, Japan

GSK Investigational Site, Kanagawa 232-0064, Japan

GSK Investigational Site, Kanagawa 235-0045, Japan

GSK Investigational Site, Kanagawa 252-0302, Japan

GSK Investigational Site, Kanagawa 253-0044, Japan

GSK Investigational Site, Kochi 780-0088, Japan

GSK Investigational Site, Kumamoto 867-0041, Japan

GSK Investigational Site, Kumamoto 862-0960, Japan

GSK Investigational Site, Kyoto 600-8558, Japan

GSK Investigational Site, Kyoto 601-1495, Japan

GSK Investigational Site, Miyagi 980-0021, Japan

GSK Investigational Site, Miyagi 985-0852, Japan

GSK Investigational Site, Nagano 399-0006, Japan

GSK Investigational Site, Nagano 399-0036, Japan

GSK Investigational Site, Oita 870-0039, Japan

GSK Investigational Site, Okinawa 900-0029, Japan

GSK Investigational Site, Osaka 530-0012, Japan

GSK Investigational Site, Osaka 536-0023, Japan

GSK Investigational Site, Osaka 538-0044, Japan

GSK Investigational Site, Osaka 577-0803, Japan

GSK Investigational Site, Osaka 582-0019, Japan

GSK Investigational Site, Saitama 358-0011, Japan

GSK Investigational Site, Saitama 350-0035, Japan

GSK Investigational Site, Saitama 350-0851, Japan

GSK Investigational Site, Saitama 354-0031, Japan

GSK Investigational Site, Saitama 355-0321, Japan

GSK Investigational Site, Saitama 332-0012, Japan

GSK Investigational Site, Shizuoka 424-0855, Japan

GSK Investigational Site, Tochigi 329-0433, Japan

GSK Investigational Site, Tokyo 103-0002, Japan

GSK Investigational Site, Tokyo 103-0027, Japan

GSK Investigational Site, Tokyo 125-0054, Japan

GSK Investigational Site, Tokyo 143-0015, Japan

Starting date: February 2013
Last updated: March 26, 2015