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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

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ClinicalTrials.gov Identifier: NCT01777282
Recruitment Status : Completed
First Posted : January 28, 2013
Results First Posted : October 14, 2015
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE January 24, 2013
First Posted Date  ICMJE January 28, 2013
Results First Submitted Date  ICMJE September 14, 2015
Results First Posted Date  ICMJE October 14, 2015
Last Update Posted Date May 3, 2017
Actual Study Start Date  ICMJE February 23, 2013
Actual Primary Completion Date January 27, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2015)
  • Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) [ Time Frame: From Baseline through Week 52 ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2013)
Incidence of AEs and hypoglycemic events [ Time Frame: 52 weeks ]
Long term safety and tolerability
Change History Complete list of historical versions of study NCT01777282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2015)
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 [ Time Frame: Baseline and Week 52 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2013)
  • Change from Baseline at Week 52 of glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline to 52 weeks ]
    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 ]
    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 ]
    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 ]
    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 ]
    The percent of subjects withdrawn due to hyperglycemia from each arm of the study will be assessed through Week 52
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • Drug: Albiglutide
    Albiglutide is a fixed-dose, fully disposable pen injector system for delivery of albiglutide from a prefilled dual chamber glass cartridge that is an integral part of the pen. It is intended for single use by the subject. It is designed for manual reconstitution of the dose, priming, and insertion of the pen needle, and manual injection by the subject. The subject will inject albiglutide 30 mg weekly for 52 weeks (with optional uptitration to 50 mg weekly) subcutaneously into the abdomen, alternating between left and right sides. The pen is designed to work with standard pen needles.
  • Drug: Sulfonylurea
    Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
  • Drug: Biguanide
    Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
  • Drug: Glinide
    Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
  • Drug: Thiazolidinedione
    Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
  • Drug: Alpha-glucosidase inhibitor
    Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
Study Arms  ICMJE
  • Active Comparator: Albiglutide + Sulfonylurea
    Albiglutide in combination with background sulfonylurea
    Interventions:
    • Drug: Albiglutide
    • Drug: Sulfonylurea
  • Active Comparator: Albiglutide + Biguanide
    Albiglutide in combination with background biguanide
    Interventions:
    • Drug: Albiglutide
    • Drug: Biguanide
  • Active Comparator: Albiglutide + Glinide
    Albiglutide in combination with background glinide
    Interventions:
    • Drug: Albiglutide
    • Drug: Glinide
  • Active Comparator: Albiglutide + Thiazolidinedione
    Albiglutide in combination with background thiazolidinedione
    Interventions:
    • Drug: Albiglutide
    • Drug: Thiazolidinedione
  • Active Comparator: Albiglutide + Alpha-glucosidase inhibitor
    Albiglutide in combination with background alpha-glucosidase inhibitor
    Interventions:
    • Drug: Albiglutide
    • Drug: Alpha-glucosidase inhibitor
Publications * Okuda I, Wilson TH, Yue L, Nakajima H, Carr MC, Tsuboi M, Nino A, Seino Y. Albiglutide, a weekly GLP-1 receptor agonist, improves glycemic parameters in Japanese patients with type 2 diabetes over 1 year when added to single oral antidiabetic drugs. Curr Med Res Opin. 2017 Mar;33(3):431-438. doi: 10.1080/03007995.2016.1261817. Epub 2016 Dec 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2015)
374
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2013)
360
Actual Study Completion Date  ICMJE January 27, 2015
Actual Primary Completion Date January 27, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01777282
Other Study ID Numbers  ICMJE 116170
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date March 2017

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