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 has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01777282
First received: January 24, 2013
Last updated: November 5, 2015
Last verified: October 2015

January 24, 2013
November 5, 2015
February 2013
January 2015   (final data collection date for primary outcome measure)
  • Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) [ Time Frame: From Baseline through Week 52 ] [ Designated as safety issue: No ]
    An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. Non-serious hypoglycemia events are not included.
  • Number of Participants With Any Hypoglycemic Event [ Time Frame: From Baseline through Week 52 ] [ Designated as safety issue: No ]
    Hypoglycemia events are defined with respect to low plasma glucose level, mostly accompanied by typical symptoms and/or assistance needed from third party with glucose administration. These events were reported by the investigators upon verification of the plasma glucose levels, symptoms and assistance recorded by the participants, and/or plasma glucose values obtained from laboratory evaluations.
Incidence of AEs and hypoglycemic events [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Long term safety and tolerability
Complete list of historical versions of study NCT01777282 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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 non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis.
  • 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) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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 non-missing value before the start of treatment. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%.
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline FPG observation carried forward for the analysis.
  • Change From Baseline in Body Weight at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline weight observation carried forward for the analysis.
  • Time to Study Withdrawal Due to Hyperglycemia [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose >=280 mg/dL (>=15.5 mmol/L) from >=Week 2 to <Week 12 or >=230 mg/dL (>=12.8 mmol/L) from >=Week 12 to <Week 52.
  • 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
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.
 
Completed
374
January 2015
January 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
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2015

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