A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)

NCT01733758 | Completed Phase 3 Results DMC

• 1 other identifier: 113121
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 74

Brief Summary

This study is designed to examine the efficacy and safety of 2 dose levels of weekly subcutaneously injected albiglutide compared with placebo and an open label reference arm of daily subcutaneous injections of liraglutide, in Japanese subjects with Type 2 diabetes mellitus.

Conditions

Diabetes Mellitus, Type 2

Keywords

albiglutide; Japanese; GSK716155; Type 2 diabetes mellitus; glucagon-like peptide 1

Outcome Measures

Primary Outcomes (2)

• Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

  HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Based on analysis of covariance (ANCOVA): Change at Week 24 = treatment (placebo, albiglutide 30 mg, albiglutide 50 mg) + Baseline HbA1c + prior diabetes therapy + age category (\<65 years versus ≥65 years). Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c carried forward for the analysis unless the value is past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group and not included in the primary endpoint analysis model. Descriptive summary statistics are provided as a separate outcome measure.

  Baseline and Week 24

• Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24

  HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c value carried forward for the summary, unless the value was past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints.

  Baseline and Week 24

Secondary Outcomes (9)

• Change From Baseline in HbA1c at Week 52

  Baseline and Week 52

• Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 24

  Week 24

• Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 52

  Week 52

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

  Baseline and Week 24

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52

  Baseline and Week 52

Study Arms (4)

Albiglutide 30 mg weekly

EXPERIMENTAL

Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks

Drug: Albiglutide 30 mg weekly; Drug: Placebo

Albiglutide 50 mg weekly

EXPERIMENTAL

Subjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52

Drug: Albiglutide 50 mg weekly

Placebo

PLACEBO COMPARATOR

Subjects will be randomly assigned to double blind matching albiglutide placebo administered weekly. Subjects will then cross-over to double-blind treatment with albiglutide 30 mg weekly at Week 24 until Week 52

Drug: Placebo

Liraglutide 0.9 mg daily

ACTIVE COMPARATOR

Subjects will be randomly assigned to open-label liraglutide for 52 weeks

Drug: Liraglutide 0.9 mg daily

Interventions

Albiglutide 30 mg weekly DRUG

Albiglutide will be available as a pen injector that delivers 30mg of albiglutide

Albiglutide 30 mg weekly

Albiglutide 50 mg weekly DRUG

Albiglutide will be available as a pen injector that delivers 50mg of albiglutide

Albiglutide 50 mg weekly

Placebo DRUG

Albiglutide matching placebo will be available as a pen injector

Albiglutide 30 mg weekly; Placebo

Liraglutide 0.9 mg daily DRUG

Liraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose

Liraglutide 0.9 mg daily

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with diagnosis of Type 2 Diabetes Mellitus, treated with diet and exercise or a stable dose of 1 OAD at screening
• Body mass index (BMI) 17 to 40 kg/ m\^2 inclusive
• Subjects who are OAD naïve, HbA1c between 7.0% and 10.0% at Screening and at Visit 2; for subjects who enter the study with 1 OAD, HbA1c between 6.5% and 9.5% at Screening and HbA1c between 7.0% and 10.0% at Visit 2
• Creatinine clearance \>30 mL/min (calculated using the Cockcroft-Gault formula)

You may not qualify if:

• 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 TZD or GLP-1R agonist within 4 months before Screening

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (74)

GSK Investigational Site

Aichi, 456-0058, Japan

Location

GSK Investigational Site

Chiba, 263-0043, Japan

Location

GSK Investigational Site

Ehime, 790-0067, Japan

Location

GSK Investigational Site

Ehime, 792-0045, Japan

Location

GSK Investigational Site

Ehime, 792-8586, Japan

Location

GSK Investigational Site

Fukuoka, 810-0014, Japan

Location

GSK Investigational Site

Fukuoka, 812-0053, Japan

Location

GSK Investigational Site

Fukuoka, 815-8588, Japan

Location

GSK Investigational Site

Fukuoka, 819-0168, Japan

Location

GSK Investigational Site

Fukushima, 960-0418, Japan

Location

GSK Investigational Site

Fukushima, 961-0416, Japan

Location

GSK Investigational Site

Fukushima, 963-8851, Japan

Location

GSK Investigational Site

Fukushima, 964-8501, Japan

Location

GSK Investigational Site

Gunma, 370-3573, Japan

Location

GSK Investigational Site

Gunma, 379-0116, Japan

Location

GSK Investigational Site

Hiroshima, 731-0103, Japan

Location

GSK Investigational Site

Hokkaido, 040-8585, Japan

Location

GSK Investigational Site

Hokkaido, 062-0007, Japan

Location

GSK Investigational Site

Hokkaido, 070-0002, Japan

Location

GSK Investigational Site

Hokkaido, 072-0012, Japan

Location

GSK Investigational Site

Hokkaido, 080-0010, Japan

Location

GSK Investigational Site

Hokkaido, 080-0016, Japan

Location

GSK Investigational Site

Hyōgo, 670-0074, Japan

Location

GSK Investigational Site

Ibaraki, 300-0835, Japan

Location

GSK Investigational Site

Ibaraki, 300-1512, Japan

Location

GSK Investigational Site

Ibaraki, 311-0113, Japan

Location

GSK Investigational Site

Kagawa, 760-0017, Japan

Location

GSK Investigational Site

Kagawa, 760-0076, Japan

Location

GSK Investigational Site

Kagoshima, 890-0061, Japan

Location

GSK Investigational Site

Kanagawa, 212-0024, Japan

Location

GSK Investigational Site

Kanagawa, 232-0064, Japan

Location

GSK Investigational Site

Kanagawa, 235-0045, Japan

Location

GSK Investigational Site

Kanagawa, 238-0011, Japan

Location

GSK Investigational Site

Kanagawa, 242-0004, Japan

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GSK Investigational Site

Kanagawa, 253-0044, Japan

Location

GSK Investigational Site

Kochi, 780-0088, Japan

Location

GSK Investigational Site

Kumamoto, 862-0976, Japan

Location

GSK Investigational Site

Kumamoto, 866-8660, Japan

Location

GSK Investigational Site

Kumamoto, 867-0041, Japan

Location

GSK Investigational Site

Kyoto, 600-8558, Japan

Location

GSK Investigational Site

Kyoto, 601-1495, Japan

Location

GSK Investigational Site

Miyagi, 980-0021, Japan

Location

GSK Investigational Site

Miyagi, 985-0852, Japan

Location

GSK Investigational Site

Nagano, 385-0022, Japan

Location

GSK Investigational Site

Nagano, 399-0006, Japan

Location

GSK Investigational Site

Nagano, 399-0036, Japan

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GSK Investigational Site

Nara, 634-0007, Japan

Location

GSK Investigational Site

Okinawa, 901-0243, Japan

Location

GSK Investigational Site

Osaka, 530-0001, Japan

Location

GSK Investigational Site

Osaka, 530-0004, Japan

Location

GSK Investigational Site

Osaka, 530-0012, Japan

Location

GSK Investigational Site

Osaka, 532-0026, Japan

Location

GSK Investigational Site

Osaka, 536-0023, Japan

Location

GSK Investigational Site

Osaka, 538-0044, Japan

Location

GSK Investigational Site

Osaka, 577-0803, Japan

Location

GSK Investigational Site

Ōita, 870-0039, Japan

Location

GSK Investigational Site

Ōita, 876-0851, Japan

Location

GSK Investigational Site

Saitama, 332-0012, Japan

Location

GSK Investigational Site

Saitama, 350-0035, Japan

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GSK Investigational Site

Saitama, 350-0851, Japan

Location

GSK Investigational Site

Saitama, 354-0031, Japan

Location

GSK Investigational Site

Saitama, 355-0321, Japan

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GSK Investigational Site

Saitama, 358-0011, Japan

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GSK Investigational Site

Shizuoka, 424-0855, Japan

Location

GSK Investigational Site

Tochigi, 329-0433, Japan

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GSK Investigational Site

Tokyo, 103-0002, Japan

Location

GSK Investigational Site

Tokyo, 103-0027, Japan

Location

GSK Investigational Site

Tokyo, 103-0028, Japan

Location

GSK Investigational Site

Tokyo, 104-0031, Japan

Location

GSK Investigational Site

Tokyo, 104-0061, Japan

Location

GSK Investigational Site

Tokyo, 125-0054, Japan

Location

GSK Investigational Site

Tokyo, 136-0073, Japan

Location

GSK Investigational Site

Tokyo, 143-0015, Japan

Location

GSK Investigational Site

Yamaguchi, 755-0047, Japan

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

rGLP-1 protein; Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: February 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: February 1, 2015
• Last Updated: September 22, 2016
• Results First Posted: May 18, 2015

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (74)