Phase 3 · Liraglutide

NCT00700817 trial results

The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Extension

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 (Percentage point of total HbA1c), Week 0, Week 26. Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg: -1.24; Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg: -1.5; Sita -> Sita: -0.9.

Participants
665
Status
completed
Completed
2010-06
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT00700817), updated at source Mar 8, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00700817 measured first

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26Percentage point of total HbA1c · Week 0, Week 26 · least squares mean
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgn=211Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgn=214Sita -> Sitan=210Sita -> Sita -> Lira 1.2 mgn=0Sita -> Sita -> Lira 1.8 mgn=0
-1.24(0.07)-1.5(0.06)-0.9(0.07)not reportednot reported
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52Percentage point of total HbA1c · Week 0, Week 52 · least squares mean
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgn=211Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgn=214Sita -> Sitan=210Sita -> Sita -> Lira 1.2 mgn=0Sita -> Sita -> Lira 1.8 mgn=0
-1.29(0.07)-1.51(0.07)-0.88(0.07)not reportednot reported
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78Percentage point of total HbA1c · Week 0, Week 78 · least squares mean
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgn=211Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgn=214Sita -> Sitan=0Sita -> Sita -> Lira 1.2 mgn=0Sita -> Sita -> Lira 1.8 mgn=0
-0.94(0.08)-1.28(0.07)not reportednot reportednot reported
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78Percentage point of total HbA1c · Week 52, Week 78 · mean
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgn=0Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgn=0Sita -> Sitan=0Sita -> Sita -> Lira 1.2 mgn=67Sita -> Sita -> Lira 1.8 mgn=68
not reportednot reportednot reported-0.24(0.7)-0.45(0.9)
Side effects by arm

Side effects in NCT00700817

Percent of participants affected, The adverse events were collected in a timeframe of 78 weeks.. The most common events the registry lists.

EventLira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> Sita
Any serious event5.4%8.7%7.8%
Nausea21.7%28%16.4%
Nasopharyngitis14.9%16.5%14.6%
Headache10.4%14.2%15.1%
Diarrhoea9.5%13.3%11%
Vomiting8.1%11%6.8%
Dyspepsia3.6%7.8%5%
Upper respiratory tract infection7.2%5%6.4%
Constipation4.5%6.4%4.6%
Back pain5.9%6.4%5.9%
Dizziness4.5%6.4%3.7%
Hypertension5.9%6.4%3.2%
Influenza6.3%3.2%4.1%
Fatigue4.1%6%2.3%
Decreased appetite3.6%5.5%4.1%
Blood calcitonin increased4.1%5%2.7%
Secondary outcomes

What else it measured

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26percentage of subjects · Week 0, Week 26 · number
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgn=221Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgn=218Sita -> Sitan=219Sita -> Sita -> Lira 1.2 mgn=0Sita -> Sita -> Lira 1.8 mgn=0
435522not reportednot reported
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52percentage of subjects · Week 0, Week 52 · number
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgn=211Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgn=214Sita -> Sitan=210Sita -> Sita -> Lira 1.2 mgn=0Sita -> Sita -> Lira 1.8 mgn=0
506327not reportednot reported
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78percentage of subjects · Week 0, Week 78 · number
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgn=211Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgn=214Sita -> Sitan=0Sita -> Sita -> Lira 1.2 mgn=0Sita -> Sita -> Lira 1.8 mgn=0
3551not reportednot reportednot reported
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78percentage of subjects · Week 0, Week 78 · number
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgn=0Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgn=0Sita -> Sitan=0Sita -> Sita -> Lira 1.2 mgn=67Sita -> Sita -> Lira 1.8 mgn=68
not reportednot reportednot reported4950
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26percentage of subjects · Week 0, Week 26 · number
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgn=221Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgn=218Sita -> Sitan=219Sita -> Sita -> Lira 1.2 mgn=0Sita -> Sita -> Lira 1.8 mgn=0
233612not reportednot reported
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52percentage of subjects · Week 0, Week 52 · number
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgn=211Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgn=214Sita -> Sitan=210Sita -> Sita -> Lira 1.2 mgn=0Sita -> Sita -> Lira 1.8 mgn=0
244017not reportednot reported
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78percentage of subjects · Week 0, Week 78 · number
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgn=211Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgn=214Sita -> Sitan=0Sita -> Sita -> Lira 1.2 mgn=0Sita -> Sita -> Lira 1.8 mgn=0
1227not reportednot reportednot reported
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78percentage of subjects · Week 0, Week 78 · number
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgn=0Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgn=0Sita -> Sitan=0Sita -> Sita -> Lira 1.2 mgn=67Sita -> Sita -> Lira 1.8 mgn=68
not reportednot reportednot reported2925
Mean Change From Baseline in Body Weight at Week 26kg · Week 0, Week 26 · least squares mean
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgn=215Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgn=214Sita -> Sitan=215Sita -> Sita -> Lira 1.2 mgn=0Sita -> Sita -> Lira 1.8 mgn=0
-2.86(0.27)-3.38(0.27)-0.96(0.27)not reportednot reported
Mean Change From Baseline in Body Weight at Week 52kg · Week 0, Week 52 · least squares mean
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgn=215Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgn=214Sita -> Sitan=215Sita -> Sita -> Lira 1.2 mgn=0Sita -> Sita -> Lira 1.8 mgn=0
-2.78(0.31)-3.68(0.31)-1.16(0.31)not reportednot reported
Mean Change in Body Weight From Week 52 to Week 78kg · Week 52, Week 78 · mean
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgn=0Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgn=0Sita -> Sitan=0Sita -> Sita -> Lira 1.2 mgn=67Sita -> Sita -> Lira 1.8 mgn=68
not reportednot reportednot reported-1.64(3)-2.48(3.6)
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26mmol/L · Week 0, Week 26 · least squares mean
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgn=210Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgn=212Sita -> Sitan=210Sita -> Sita -> Lira 1.2 mgn=0Sita -> Sita -> Lira 1.8 mgn=0
-1.87(0.15)-2.14(0.15)-0.83(0.15)not reportednot reported
The trial

How NCT00700817 was run

This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone. The trial has been extended by 52 weeks. The extension will consist of two 26-week periods: 1. Week 27-52 after randomisation \- All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen. 2. Week 53-78 after randomisation * Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals. * Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.

  • Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg: Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
  • Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg: Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
  • Sita -> Sita: Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
  • Sita -> Sita -> Lira 1.2 mg: Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
  • Sita -> Sita -> Lira 1.8 mg: Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Who could join the trial

Inclusion Criteria: * Type 2 diabetes * Treatment with metformin alone for at least three months * HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive) * Body Mass Index (BMI) less than or equal to 45.0 Exclusion Criteria: * Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors * Treatment with anti-diabetic drugs other than metformin within the last three months * Any serious medical condition * Females who are pregnant, have the intention of becoming pregnant or are breastfeeding

Published papers

Papers from NCT00700817

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

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