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Study · Randomized controlled trial · 2011

8 results

One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel-group, open-label trial.

Pratley R, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Garber A, Thomsen AB, Hartvig H, Davies M

International journal of clinical practice1 Mar 2011Cited by 193 (Europe PMC)

Summary

AimThe aim of this study was to compare the efficacy and safety of once-daily human glucagon-like peptide-1 analogue liraglutide with dipeptidyl peptidase-4 inhibitor sitagliptin, each added to metformin, over 52 weeks in individuals with type 2 diabetes.MethodsIn an open-label, parallel-group trial, metformin-treated participants were randomised to liraglutide 1.2 mg/day (n=225), liraglutide 1.8 mg/day (n=221) or sitagliptin 100 mg/day (n=219) for 26 weeks (main phase). Participants continued the same treatment in a 26-week extension.ResultsLiraglutide (1.2 or 1.8 mg) was superior to sitagliptin for reducing HbA(1c) from baseline (8.4-8.5%) to 52 weeks: -1.29% and -1.51% vs. -0.88% respectively. Estimated mean treatment differences between liraglutide and sitagliptin were as follows: -0.40% (95% confidence interval -0.59 to -0.22) for 1.2 mg and -0.63% (-0.81 to -0.44) for 1.8 mg (both p<0.0001). Weight loss was greater with liraglutide 1.2 mg (-2.78 kg) and 1.8 mg (-3.68 kg) than sitagliptin (-1.16 kg) (both p<0.0001). Diabetes Treatment Satisfaction Questionnaire scores increased significantly more with liraglutide 1.8 mg than with sitagliptin (p=0.03). Proportions of participants reporting adverse events were generally comparable; minor hypoglycaemia was 8.1%, 8.3% and 6.4% for liraglutide 1.2 mg, 1.8 mg and sitagliptin respectively. Gastrointestinal side effects, mainly nausea, initially occurred more frequently with liraglutide, but declined after several weeks.Conclusion  Liraglutide provides greater sustained glycaemic control and body weight reduction over 52 weeks. Treatment satisfaction was significantly greater with 1.8 mg liraglutide, similar to 26-week results. The safety profiles of liraglutide and sitagliptin are consistent with previous reports.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes on metformin, liraglutide 1.2 mg reduced HbA1c more than sitagliptin at 52 weeks (-1.29% versus -0.88%; difference -0.40%, 95% CI -0.59 to -0.22; p<0.0001).

    In plain wordsIn people with type 2 diabetes on metformin, liraglutide 1.2 mg lowered HbA1c more than sitagliptin over 52 weeks.

    Outcome
    DecreaseHbA1c change from baseline to 52 weeks, liraglutide 1.2 mg
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg/day
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.2 mg/day · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Liraglutide (1.2 or 1.8 mg) was superior to sitagliptin for reducing HbA(1c) from baseline (8.4-8.5%) to 52 weeks: -1.29% and -1.51% vs. -0.88% respectively.
    2 context sentences
    Summary · context
    Estimated mean treatment differences between liraglutide and sitagliptin were as follows: -0.40% (95% confidence interval -0.59 to -0.22) for 1.2 mg and -0.63% (-0.81 to -0.44) for 1.8 mg (both p<0.0001).
    Summary · context
    In an open-label, parallel-group trial, metformin-treated participants were randomised to liraglutide 1.2 mg/day (n=225), liraglutide 1.8 mg/day (n=221) or sitagliptin 100 mg/day (n=219) for 26 weeks (main phase).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes on metformin, liraglutide 1.8 mg reduced HbA1c more than sitagliptin at 52 weeks (-1.51% versus -0.88%; difference -0.63%, 95% CI -0.81 to -0.44; p<0.0001).

    In plain wordsIn people with type 2 diabetes on metformin, liraglutide 1.8 mg lowered HbA1c more than sitagliptin over 52 weeks.

    Outcome
    DecreaseHbA1c change from baseline to 52 weeks, liraglutide 1.8 mg
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg/day
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.8 mg/day · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Liraglutide (1.2 or 1.8 mg) was superior to sitagliptin for reducing HbA(1c) from baseline (8.4-8.5%) to 52 weeks: -1.29% and -1.51% vs. -0.88% respectively.
    2 context sentences
    Summary · context
    Estimated mean treatment differences between liraglutide and sitagliptin were as follows: -0.40% (95% confidence interval -0.59 to -0.22) for 1.2 mg and -0.63% (-0.81 to -0.44) for 1.8 mg (both p<0.0001).
    Summary · context
    In an open-label, parallel-group trial, metformin-treated participants were randomised to liraglutide 1.2 mg/day (n=225), liraglutide 1.8 mg/day (n=221) or sitagliptin 100 mg/day (n=219) for 26 weeks (main phase).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes on metformin, weight loss was greater with liraglutide 1.2 mg (-2.78 kg) than with sitagliptin (-1.16 kg; p<0.0001).

    In plain wordsIn people with type 2 diabetes on metformin, liraglutide 1.2 mg led to more weight loss than sitagliptin.

    Outcome
    DecreaseWeight change, liraglutide 1.2 mg
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg/day
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    1.2 mg/day · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Weight loss was greater with liraglutide 1.2 mg (-2.78 kg) and 1.8 mg (-3.68 kg) than sitagliptin (-1.16 kg) (both p<0.0001).
    1 context sentence
    Summary · context
    In an open-label, parallel-group trial, metformin-treated participants were randomised to liraglutide 1.2 mg/day (n=225), liraglutide 1.8 mg/day (n=221) or sitagliptin 100 mg/day (n=219) for 26 weeks (main phase).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes on metformin, weight loss was greater with liraglutide 1.8 mg (-3.68 kg) than with sitagliptin (-1.16 kg; p<0.0001).

    In plain wordsIn people with type 2 diabetes on metformin, liraglutide 1.8 mg led to more weight loss than sitagliptin.

    Outcome
    DecreaseWeight change, liraglutide 1.8 mg
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg/day
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    1.8 mg/day · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Weight loss was greater with liraglutide 1.2 mg (-2.78 kg) and 1.8 mg (-3.68 kg) than sitagliptin (-1.16 kg) (both p<0.0001).
    1 context sentence
    Summary · context
    In an open-label, parallel-group trial, metformin-treated participants were randomised to liraglutide 1.2 mg/day (n=225), liraglutide 1.8 mg/day (n=221) or sitagliptin 100 mg/day (n=219) for 26 weeks (main phase).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes on metformin, treatment satisfaction scores increased significantly more with liraglutide 1.8 mg than with sitagliptin (p=0.03).

    In plain wordsIn people with type 2 diabetes on metformin, liraglutide 1.8 mg raised treatment satisfaction more than sitagliptin.

    Outcome
    IncreaseDiabetes Treatment Satisfaction Questionnaire score, liraglutide 1.8 mg
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg/day
    Outcome group
    Patient-reported outcomes · Metabolic and weight
    Studied dose
    1.8 mg/day · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Diabetes Treatment Satisfaction Questionnaire scores increased significantly more with liraglutide 1.8 mg than with sitagliptin (p=0.03).
    1 context sentence
    Summary · context
    In an open-label, parallel-group trial, metformin-treated participants were randomised to liraglutide 1.2 mg/day (n=225), liraglutide 1.8 mg/day (n=221) or sitagliptin 100 mg/day (n=219) for 26 weeks (main phase).
  6. 06HumanRandomized controlled trialSafety outcome

    In patients with type 2 diabetes on metformin, the proportions reporting adverse events were generally comparable between liraglutide and sitagliptin.

    In plain wordsIn people with type 2 diabetes on metformin, side effects were reported about as often with liraglutide as with sitagliptin.

    Outcome
    No significant changeProportion of participants reporting adverse events
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg/day
    Outcome group
    Adverse events · Whole body
    Studied dose
    1.2 and 1.8 mg/day · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Proportions of participants reporting adverse events were generally comparable
    1 context sentence
    Summary · context
    In an open-label, parallel-group trial, metformin-treated participants were randomised to liraglutide 1.2 mg/day (n=225), liraglutide 1.8 mg/day (n=221) or sitagliptin 100 mg/day (n=219) for 26 weeks (main phase).
  7. 07HumanRandomized controlled trialSafety outcome

    In patients with type 2 diabetes on metformin, minor hypoglycaemia occurred in 8.1% with liraglutide 1.2 mg, 8.3% with 1.8 mg and 6.4% with sitagliptin.

    In plain wordsIn type 2 diabetes on metformin, mild low blood sugar occurred in 8.1% on liraglutide 1.2 mg, 8.3% on 1.8 mg, 6.4% on sitagliptin.

    Outcome
    Not applicableMinor hypoglycaemia
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg/day
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    1.2 and 1.8 mg/day · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    minor hypoglycaemia was 8.1%, 8.3% and 6.4% for liraglutide 1.2 mg, 1.8 mg and sitagliptin respectively.
    1 context sentence
    Summary · context
    In an open-label, parallel-group trial, metformin-treated participants were randomised to liraglutide 1.2 mg/day (n=225), liraglutide 1.8 mg/day (n=221) or sitagliptin 100 mg/day (n=219) for 26 weeks (main phase).
  8. 08HumanRandomized controlled trialSafety outcome

    In patients with type 2 diabetes on metformin, gastrointestinal side effects, mainly nausea, initially occurred more often with liraglutide than with sitagliptin but declined after several weeks.

    In plain wordsIn people with type 2 diabetes on metformin, nausea and other gut side effects were more common with liraglutide at first, then declined.

    Outcome
    IncreaseGastrointestinal side effects, mainly nausea
    Study

    n: not reported in source

    Comparator
    Sitagliptin 100 mg/day
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1.2 and 1.8 mg/day · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Gastrointestinal side effects, mainly nausea, initially occurred more frequently with liraglutide, but declined after several weeks.
    1 context sentence
    Summary · context
    In an open-label, parallel-group trial, metformin-treated participants were randomised to liraglutide 1.2 mg/day (n=225), liraglutide 1.8 mg/day (n=221) or sitagliptin 100 mg/day (n=219) for 26 weeks (main phase).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00700817

The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

Novo Nordisk A/Sn = 665Jun 2008 to Jun 2010

Diabetes · Diabetes Mellitus, Type 2

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    12 Oct 2026, 12:10 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:05 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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