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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT01777282 (opens ClinicalTrials.gov in a new tab)Other id116170
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Glucagon, does not test it. It appears in the conditions.

Overview

Status
Completed
Phase
Phase 3
Enrollment
374 participants (actual)
Sponsor
GlaxoSmithKline · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Japan

Start
23 Feb 2013
Primary completion
27 Jan 2015
Completion
27 Jan 2015
First posted
28 Jan 2013 (estimated)
Last update posted
3 May 2017
Conditions
Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 3

    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

    NCT01777282

    23 Feb 2013 to 27 Jan 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • AlbiglutideDrug
  • SulfonylureaDrug
  • BiguanideDrug
  • GlinideDrug
  • ThiazolidinedioneDrug
  • Alpha-glucosidase inhibitorDrug

Arms5

  • Active comparator

    Albiglutide + Sulfonylurea

    Albiglutide in combination with background sulfonylurea

  • Active comparator

    Albiglutide + Biguanide

    Albiglutide in combination with background biguanide

  • Active comparator

    Albiglutide + Glinide

    Albiglutide in combination with background glinide

  • Active comparator

    Albiglutide + Thiazolidinedione

    Albiglutide in combination with background thiazolidinedione

  • Active comparator

    Albiglutide + Alpha-glucosidase inhibitor

    Albiglutide in combination with background alpha-glucosidase inhibitor

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)

    Time frame · From Baseline through Week 52

    Registry description

    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.

  2. Number of Participants With Any Hypoglycemic Event

    Time frame · From Baseline through Week 52

    Registry description

    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.

Secondary outcomes(5)

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52

    Time frame · Baseline and Week 52

    Registry description

    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.

  2. 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

    Registry description

    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%.

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

    Time frame · Baseline and Week 52

    Registry description

    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.

  4. Change From Baseline in Body Weight at Week 52

    Time frame · Baseline and Week 52

    Registry description

    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.

  5. Time to Study Withdrawal Due to Hyperglycemia

    Time frame · Week 52

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· From Baseline through Week 52

Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)

GroupValue (Participants)
Albiglutide Plus (+) Background OAD (Sulfonylurea)97
Albiglutide Plus (+) Background OAD (Biguanide)47
Albiglutide Plus (+) Background OAD (Glinide)58
Albiglutide Plus (+) Background OAD (Thiazolidinedione)49
Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)43
Primary outcomeNumber· From Baseline through Week 52

Number of Participants With Any Hypoglycemic Event

GroupValue (Participants)
Albiglutide Plus (+) Background OAD (Sulfonylurea)17
Albiglutide Plus (+) Background OAD (Biguanide)1
Albiglutide Plus (+) Background OAD (Glinide)4
Albiglutide Plus (+) Background OAD (Thiazolidinedione)2
Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)0
Secondary and other outcome results(5)
Secondary outcomeMean· Baseline and Week 52

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52

GroupValue (Percentage of HbA1c in the blood)Spread
Albiglutide Plus (+) Background OAD (Sulfonylurea)-1.040.657
Albiglutide Plus (+) Background OAD (Biguanide)-0.940.623
Albiglutide Plus (+) Background OAD (Glinide)-0.950.836
Albiglutide Plus (+) Background OAD (Thiazolidinedione)-1.420.771
Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)-1.390.770
Secondary outcomeNumber· 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 52)

GroupValue (Percentage of participants)
Albiglutide Plus (+) Background OAD (Sulfonylurea)20.0
Albiglutide Plus (+) Background OAD (Biguanide)26.9
Albiglutide Plus (+) Background OAD (Glinide)24.6
Albiglutide Plus (+) Background OAD (Thiazolidinedione)45.9
Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)26.2
Secondary outcomeMean· Baseline and Week 52

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

GroupValue (Milligrams per deciliter (mg/dL))Spread
Albiglutide Plus (+) Background OAD (Sulfonylurea)-16.428.52
Albiglutide Plus (+) Background OAD (Biguanide)-24.319.98
Albiglutide Plus (+) Background OAD (Glinide)-16.430.37
Albiglutide Plus (+) Background OAD (Thiazolidinedione)-32.127.21
Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)-33.228.38
Secondary outcomeMean· Baseline and Week 52

Change From Baseline in Body Weight at Week 52

GroupValue (Kilograms (kg))Spread
Albiglutide Plus (+) Background OAD (Sulfonylurea)0.252.167
Albiglutide Plus (+) Background OAD (Biguanide)-0.332.082
Albiglutide Plus (+) Background OAD (Glinide)-0.042.405
Albiglutide Plus (+) Background OAD (Thiazolidinedione)0.522.823
Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)-0.132.620
Secondary outcomeMean· Week 52

Time to Study Withdrawal Due to Hyperglycemia

GroupValue (Weeks)Spread
Albiglutide Plus (+) Background OAD (Sulfonylurea)13.0NA
Albiglutide Plus (+) Background OAD (Biguanide)not posted–
Albiglutide Plus (+) Background OAD (Glinide)16.53.54
Albiglutide Plus (+) Background OAD (Thiazolidinedione)not posted–
Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)not posted–

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Albiglutide Plus (+) Background OAD (Sulfonylurea)Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.–2 / 12068 / 120
Albiglutide Plus (+) Background OAD (Biguanide)Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.–0 / 6731 / 67
Albiglutide Plus (+) Background OAD (Glinide)Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.–1 / 6538 / 65
Albiglutide Plus (+) Background OAD (Thiazolidinedione)Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.–2 / 6135 / 61
Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.–3 / 6124 / 61

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedOkuda 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. PMID 27852119

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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