Phase 3 · Liraglutide

NCT01733758 trial results

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

Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 (Percentage of HbA1c in the blood), Baseline and Week 24. Placebo: 0.25; Albiglutide 30 mg Weekly: -1.10; Albiglutide 50 mg Weekly: -1.30.

Participants
494
Status
completed
Completed
2015-02
Sponsor
GlaxoSmithKline

As posted on ClinicalTrials.gov (NCT01733758), updated at source Sep 22, 2016. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01733758 measured first

Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24Percentage of HbA1c in the blood · Baseline and Week 24 · least squares mean
Placebon=77Albiglutide 30 mg Weeklyn=159Albiglutide 50 mg Weeklyn=150Open-Label Liraglutide 0.9 mg Dailyn=0
0.25(0.068)-1.10(0.047)-1.30(0.049)not reported
Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24Percentage of HbA1c in the blood · Baseline and Week 24 · mean
MeasurePlacebon=77Albiglutide 30 mg Weeklyn=159Albiglutide 50 mg Weeklyn=150Open-Label Liraglutide 0.9 mg Dailyn=103
Baseline8.16(0.877)8.06(0.783)8.15(0.825)8.07(0.787)
Week 248.39(1.066)6.98(0.735)6.83(0.659)6.87(0.642)
Change from Baseline0.24(0.715)-1.08(0.619)-1.32(0.702)-1.19(0.636)
Side effects by arm

Side effects in NCT01733758

Percent of participants affected, 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.... The most common events the registry lists.

EventPlacebo - Before SwitchPlacebo - After SwitchAlbiglutide 30 mg WeeklyAlbiglutide 50 mg WeeklyOpen Label Liraglutide 0.9 mg Daily
Any serious event0%0%3.1%4%0%
Nasopharyngitis23.4%15.4%28.1%22.7%24.3%
Constipation3.9%4.6%8.8%11.3%6.8%
Pharyngitis1.3%0%8.1%0.7%1.9%
Nausea5.2%4.6%1.3%6.7%3.9%
Injection site erythema0%1.5%1.9%6%0%
Diarrhoea5.2%0%1.3%5.3%4.9%
Bronchitis2.6%3.1%2.5%5.3%1.9%
Eczema5.2%3.1%1.3%2.7%1.9%
Hypoglycaemia2.6%4.6%5%4%2.9%
Back pain1.3%3.1%5%2.7%2.9%
Upper respiratory tract inflammation3.9%0%5%1.3%2.9%
Secondary outcomes

What else it measured

Change From Baseline in HbA1c at Week 52Percentage of HbA1c in the blood · Baseline and Week 52 · mean
Placebon=62Albiglutide 30 mg Weeklyn=148Albiglutide 50 mg Weeklyn=135Open-Label Liraglutide 0.9 mg Dailyn=95
-1.07(0.695)-1.07(0.790)-1.34(0.753)-1.17(0.776)
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 24Percentage of participants · Week 24 · number
MeasurePlacebon=77Albiglutide 30 mg Weeklyn=159Albiglutide 50 mg Weeklyn=150Open-Label Liraglutide 0.9 mg Dailyn=103
HbA1c <6.5% at Week 241314729
HbA1c <7.0% at Week 2449210066
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 52Percentage of participants · Week 52 · number
MeasurePlacebon=62Albiglutide 30 mg Weeklyn=148Albiglutide 50 mg Weeklyn=135Open-Label Liraglutide 0.9 mg Dailyn=95
HbA1c <6.5% at Week 5214445327
HbA1c <7.0% at Week 5233828557
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24Milligrams per deciliter (mg/dL) · Baseline and Week 24 · mean
MeasurePlacebon=77Albiglutide 30 mg Weeklyn=159Albiglutide 50 mg Weeklyn=150Open-Label Liraglutide 0.9 mg Dailyn=103
Baseline159.3(37.07)157.1(33.81)158.7(32.82)157.2(31.22)
Week 24167.0(37.51)132.2(26.09)128.8(24.03)128.1(23.68)
Change from Baseline at Week 247.7(31.77)-24.9(27.58)-30.0(27.83)-29.1(29.00)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52Milligrams per deciliter (mg/dL) · Baseline and Week 52 · mean
MeasurePlacebon=62Albiglutide 30 mg Weeklyn=147Albiglutide 50 mg Weeklyn=135Open-Label Liraglutide 0.9 mg Dailyn=95
Baseline154.5(35.65)154.7(29.36)159.8(33.52)157.4(30.27)
Week 52131.7(23.13)131.9(24.14)126.3(24.47)127.0(20.78)
Change from Baseline at Week 52-22.7(27.38)-22.8(26.03)-33.5(31.10)-30.4(28.06)
Change From Baseline in Body Weight at Week 24Kilograms (kg) · Baseline and Week 24 · mean
MeasurePlacebon=77Albiglutide 30 mg Weeklyn=159Albiglutide 50 mg Weeklyn=150Open-Label Liraglutide 0.9 mg Dailyn=103
Baseline68.65(12.088)69.46(13.453)71.54(12.907)72.65(13.758)
Week 2468.15(12.139)69.78(13.793)71.50(13.023)72.30(13.459)
Change from Baseline at Week 24-0.50(1.700)0.32(1.795)-0.04(1.976)-0.34(2.587)
Change From Baseline in Body Weight at Week 52Kilograms (kg) · Baseline and Week 52 · mean
MeasurePlacebon=62Albiglutide 30 mg Weeklyn=148Albiglutide 50 mg Weeklyn=135Open-Label Liraglutide 0.9 mg Dailyn=95
Baseline68.07(11.978)70.07(13.242)71.27(12.801)72.43(12.895)
Week 5268.00(12.150)70.15(13.536)70.96(12.431)71.93(12.564)
Change from Baseline at Week 52-0.07(2.179)0.08(2.078)-0.31(2.382)-0.50(2.690)
Time to Study Withdrawal Due to HyperglycemiaWeeks · Baseline through Week 52 · median
Placebon=77Albiglutide 30 mg Weeklyn=160Albiglutide 50 mg Weeklyn=150Open-Label Liraglutide 0.9 mg Dailyn=103
NA(NA to NA)NA(NA to NA)NA(NA to NA)NA(NA to NA)
Time to Study Withdrawal for Any ReasonWeeks · Baseline through Week 52 · median
Placebon=77Albiglutide 30 mg Weeklyn=160Albiglutide 50 mg Weeklyn=150Open-Label Liraglutide 0.9 mg Dailyn=103
NA(NA to NA)NA(NA to NA)NA(NA to NA)NA(NA to NA)
The trial

How NCT01733758 was run

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.

  • Albiglutide 30 mg weekly: Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks
  • Albiglutide 50 mg weekly: Subjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52
  • Placebo: 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
  • Liraglutide 0.9 mg daily: Subjects will be randomly assigned to open-label liraglutide for 52 weeks
Who could join the trial

Inclusion Criteria: * 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) 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 TZD or GLP-1R agonist within 4 months before Screening

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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