Diabetes Mellitus, Type 2Phase 3NCT01733758

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

A Phase 3 study testing Albiglutide 30 mg weekly, Albiglutide 50 mg weekly and Liraglutide 0.9 mg daily in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 74 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Albiglutide 30 mg weekly, Albiglutide 50 mg weekly and Liraglutide 0.9 mg daily
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 494 participants
Where: 74 sitesJapan
Study dates: Feb 2013to Feb 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

74 sites in 1 country.

City, postcode or hospital

74 sites in 1 country

Japan74 sites

GSK Investigational Site
Aichi, 456-0058
GSK Investigational Site
Chiba, 263-0043
GSK Investigational Site
Ehime, 790-0067
GSK Investigational Site
Ehime, 792-0045
GSK Investigational Site
Ehime, 792-8586
GSK Investigational Site
Fukuoka, 810-0014
GSK Investigational Site
Fukuoka, 812-0053
GSK Investigational Site
Fukuoka, 815-8588
GSK Investigational Site
Fukuoka, 819-0168
GSK Investigational Site
Fukushima, 960-0418
GSK Investigational Site
Fukushima, 961-0416
GSK Investigational Site
Fukushima, 963-8851
GSK Investigational Site
Fukushima, 964-8501
GSK Investigational Site
Gunma, 370-3573
GSK Investigational Site
Gunma, 379-0116
GSK Investigational Site
Hiroshima, 731-0103
GSK Investigational Site
Hokkaido, 040-8585
GSK Investigational Site
Hokkaido, 062-0007
GSK Investigational Site
Hokkaido, 070-0002
GSK Investigational Site
Hokkaido, 072-0012
GSK Investigational Site
Hokkaido, 080-0010
GSK Investigational Site
Hokkaido, 080-0016
GSK Investigational Site
Hyōgo, 670-0074
GSK Investigational Site
Ibaraki, 300-0835
GSK Investigational Site
Ibaraki, 300-1512
GSK Investigational Site
Ibaraki, 311-0113
GSK Investigational Site
Kagawa, 760-0017
GSK Investigational Site
Kagawa, 760-0076
GSK Investigational Site
Kagoshima, 890-0061
GSK Investigational Site
Kanagawa, 212-0024
GSK Investigational Site
Kanagawa, 232-0064
GSK Investigational Site
Kanagawa, 235-0045
GSK Investigational Site
Kanagawa, 238-0011
GSK Investigational Site
Kanagawa, 242-0004
GSK Investigational Site
Kanagawa, 253-0044
GSK Investigational Site
Kochi, 780-0088
GSK Investigational Site
Kumamoto, 862-0976
GSK Investigational Site
Kumamoto, 866-8660
GSK Investigational Site
Kumamoto, 867-0041
GSK Investigational Site
Kyoto, 600-8558
GSK Investigational Site
Kyoto, 601-1495
GSK Investigational Site
Miyagi, 980-0021
GSK Investigational Site
Miyagi, 985-0852
GSK Investigational Site
Nagano, 385-0022
GSK Investigational Site
Nagano, 399-0006
GSK Investigational Site
Nagano, 399-0036
GSK Investigational Site
Nara, 634-0007
GSK Investigational Site
Ōita, 870-0039
GSK Investigational Site
Ōita, 876-0851
GSK Investigational Site
Okinawa, 901-0243
GSK Investigational Site
Osaka, 530-0001
GSK Investigational Site
Osaka, 530-0004
GSK Investigational Site
Osaka, 530-0012
GSK Investigational Site
Osaka, 532-0026
GSK Investigational Site
Osaka, 536-0023
GSK Investigational Site
Osaka, 538-0044
GSK Investigational Site
Osaka, 577-0803
GSK Investigational Site
Saitama, 332-0012
GSK Investigational Site
Saitama, 350-0035
GSK Investigational Site
Saitama, 350-0851
GSK Investigational Site
Saitama, 354-0031
GSK Investigational Site
Saitama, 355-0321
GSK Investigational Site
Saitama, 358-0011
GSK Investigational Site
Shizuoka, 424-0855
GSK Investigational Site
Tochigi, 329-0433
GSK Investigational Site
Tokyo, 103-0002
GSK Investigational Site
Tokyo, 103-0027
GSK Investigational Site
Tokyo, 103-0028
GSK Investigational Site
Tokyo, 104-0031
GSK Investigational Site
Tokyo, 104-0061
GSK Investigational Site
Tokyo, 125-0054
GSK Investigational Site
Tokyo, 136-0073
GSK Investigational Site
Tokyo, 143-0015
GSK Investigational Site
Yamaguchi, 755-0047

Other trials in Japan

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Monotherapy Study to Determine the Efficacy and Safety of 2 Dose Levels of Albiglutide in Subjects With Type 2 Diabetes Mellitus

Conditions: Diabetes Mellitus, Type 2
Being tested: Albiglutide 30 mg weekly, Albiglutide 50 mg weekly, Placebo, Liraglutide 0.9 mg daily
Keywords: albiglutide, Japanese, GSK716155, Type 2 diabetes mellitus, glucagon-like peptide 1
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Albiglutide 30 mg weeklyDrug
Albiglutide will be available as a pen injector that delivers 30mg of albiglutide
Albiglutide 50 mg weeklyDrug
Albiglutide will be available as a pen injector that delivers 50mg of albiglutide
PlaceboDrug
Albiglutide matching placebo will be available as a pen injector
Liraglutide 0.9 mg dailyDrug
Liraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose

Study groups in NCT01733758
Study group	Role	What they receive
Albiglutide 30 mg weekly	Experimental	Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks Receives: 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 Receives: 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 Receives: Drug: Placebo
Liraglutide 0.9 mg daily	Active comparator	Subjects will be randomly assigned to open-label liraglutide for 52 weeks Receives: Drug: Liraglutide 0.9 mg daily

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline and Week 24

Secondary outcomes (9)

Change From Baseline in HbA1c at 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 on or before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline.
Measured: 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
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%. Participants who discontinued the study before Week 24 had their last post-Baseline HbA1c value carried forwrad for the summary unless the value was past 14 days after the last dose of study drug.
Measured: 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
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%.
Measured: Week 52
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
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 24 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline FPG observation carried forward for the summary unless the value was 14 days past the last dose of study drug.
Measured: Baseline and Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline.
Measured: Baseline and Week 52
Change From Baseline in Body Weight at Week 24
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 24 minus the value at Baseline. Participants who discontinued from the study treatment before Week 24 had their last non-missing weight carried forward for the summary, unless the value is past 14 days after the last dose of study drug.
Measured: Baseline and Week 24
Change From Baseline in Body Weight at 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.
Measured: Baseline and Week 52
Time to Study Withdrawal Due to Hyperglycemia
Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose (FPG) ≥280 mg/dL (≥15.5 mmol/L) from ≥Week 2 to <Week 4, ≥250 mg/dL (≥13.9 mmol/L) from ≥Week 4 to <Week 12, or ≥230 mg/dL (≥12.8 mmol/L) from ≥Week 12 to <Week 52, confirmed a second evaluation within 7 days.
Measured: Baseline through Week 52
Time to Study Withdrawal for Any Reason
Time to withdrawal was calculated as the number of days between the date of first dose and the date of withdrawal plus 1. Time to withdrawal was summarized by visit.
Measured: Baseline through Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Feb 2015

First posted27 Nov 2012 (estimated)
Study startFeb 2013
Primary completionJun 2014
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 494 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01733758
Sponsor's protocol ID: 113121
Status last verified: Aug 2016
First submitted: 21 Nov 2012
Last updated: 22 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Monotherapy Study to Determine the Efficacy and Safety of 2 Dose Levels of Albiglutide in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01733758
Acronym / sponsor ID: 113121
Conditions: Diabetes Mellitus, Type 2
Keywords: albiglutide, Japanese, GSK716155, Type 2 diabetes mellitus, glucagon-like peptide 1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 494 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: Jun 2014 (actual)
Study completion: Feb 2015 (actual)
First posted: 27 Nov 2012 (estimated)
Results: Posted 18 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Albiglutide 30 mg weekly	Experimental	Drug: Albiglutide 30 mg weekly, Drug: PlaceboSubjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks
Albiglutide 50 mg weekly	Experimental	Drug: Albiglutide 50 mg weeklySubjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52
Placebo	Placebo comparator	Drug: PlaceboSubjects 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
Liraglutide 0.9 mg daily	Active comparator	Drug: Liraglutide 0.9 mg dailySubjects will be randomly assigned to open-label liraglutide for 52 weeks

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Albiglutide 30 mg weeklyAlbiglutide will be available as a pen injector that delivers 30mg of albiglutide	Drug	Albiglutide 30 mg weekly
Albiglutide 50 mg weeklyAlbiglutide will be available as a pen injector that delivers 50mg of albiglutide	Drug	Albiglutide 50 mg weekly
PlaceboAlbiglutide matching placebo will be available as a pen injector	Drug	Albiglutide 30 mg weekly, Placebo
Liraglutide 0.9 mg dailyLiraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose	Drug	Liraglutide 0.9 mg daily

Primary outcome

Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Time frame: Baseline and 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.
Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24
Time frame: Baseline and 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.

9 secondary outcomes

Change From Baseline in HbA1c at Week 52
Time frame: 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
Time frame: 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
Time frame: Week 52
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Time frame: Baseline and Week 52
Change From Baseline in Body Weight at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Body Weight at Week 52
Time frame: Baseline and Week 52
Time to Study Withdrawal Due to Hyperglycemia
Time frame: Baseline through Week 52
Time to Study Withdrawal for Any Reason
Time frame: Baseline through Week 52

Results and safety

Results posted to the registry on 18 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	77	62
Albiglutide 30 mg Weekly	160	148
Albiglutide 50 mg Weekly	150	135
Open Label Liraglutide 0.9 mg Daily	103	95

Primary outcome: Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

Time frame: Baseline and Week 24. Least squares mean (Standard Error). Unit: Percentage of HbA1c in the blood

Measure	Placebo n = 77	Albiglutide 30 mg Weekly n = 159	Albiglutide 50 mg Weekly n = 150	Open-Label Liraglutide 0.9 mg Daily n = 0
Value	0.25 (0.068)	-1.10 (0.047)	-1.30 (0.049)	–

Placebo vs Albiglutide 50 mg Weekly: Mean Difference (Net): -1.55 (95% CI -1.72 to -1.39), ANCOVA
Placebo vs Albiglutide 30 mg Weekly: Mean Difference (Net): -1.35 (95% CI -1.51 to -1.18), ANCOVA
Placebo vs Albiglutide 50 mg Weekly: p <0.0001, t-test, 2 sided

Population analysed: Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment of HbA1c.

Primary outcome: Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24

Time frame: Baseline and Week 24. Mean (Standard Deviation). Unit: Percentage of HbA1c in the blood

Measure	Placebo n = 77	Albiglutide 30 mg Weekly n = 159	Albiglutide 50 mg Weekly n = 150	Open-Label Liraglutide 0.9 mg Daily n = 103
Baseline	8.16 (0.877)	8.06 (0.783)	8.15 (0.825)	8.07 (0.787)
Week 24	8.39 (1.066)	6.98 (0.735)	6.83 (0.659)	6.87 (0.642)
Change from Baseline	0.24 (0.715)	-1.08 (0.619)	-1.32 (0.702)	-1.19 (0.636)

Population analysed: Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline assessment and at least 1 post-Baseline assessment of HbA1c on or before Week 24 provided it was not past more than 14 days after the last dose of study drug intake.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: On-therapy non-serious AEs and serious AEs (SAEs), events with an onset on or after the start date of study treatment and within 56 days after the date of the last dose of study treatment, are summarized through Week 52.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo - Before Switch	0 of 77 (0%)	33 of 77 (42.9%)	Not reported
Placebo - After Switch	0 of 65 (0%)	24 of 65 (36.9%)	Not reported
Albiglutide 30 mg Weekly	5 of 160 (3.1%)	85 of 160 (53.1%)	Not reported
Albiglutide 50 mg Weekly	6 of 150 (4%)	76 of 150 (50.7%)	Not reported
Open Label Liraglutide 0.9 mg Daily	0 of 103 (0%)	46 of 103 (44.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

74 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Albiglutide 30 mg weekly, Albiglutide 50 mg weekly and Liraglutide 0.9 mg daily in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 74 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 (time frame: Baseline and Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01733758.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2016.