Dataset Information

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.

ABSTRACT:

Aim

The 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.

Methods

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). Participants continued the same treatment in a 26-week extension.

Results

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. 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.

SUBMITTER: Pratley R

PROVIDER: S-EPMC3085127 | biostudies-literature | 2011 Apr

REPOSITORIES: biostudies-literature

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Publications

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

International journal of clinical practice 20110301 4

<h4>Aim</h4>The 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.<h4>Methods</h4>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). Partic ...[more]

PMID: 21355967

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Project description:IntroductionA slower adoption rate of fixed dose combinations (FDC) in diabetes management is partly due to insufficient data. This study evaluates the safety and efficacy of an FDC of dapagliflozin + sitagliptin + metformin hydrochloride extended release (XR), compared to a dual FDC of sitagliptin + metformin hydrochloride XR among patients with type 2 diabetes mellitus (T2DM) with poor glycemic control when treated with metformin monotherapy.MethodsA total of 274 patients with T2DM were randomized (1:1) to either arm X, receiving FDC of dapagliflozin (10 mg) + sitagliptin (100 mg) + metformin hydrochloride XR (1000 mg) (Dapa + Sita + Met) tablets, or arm Y, receiving sitagliptin phosphate (100 mg) + metformin hydrochloride XR (1000 mg) (Sita + Met) tablets, and treated for 16 weeks. The outcome measures included changes in hemoglobin A1c (HbA1c)(%), fasting plasma glucose (FPG), 2-h post-prandial glucose (PPG), weight, and the proportion of patients achieving target HbA1c levels of < 7.0% by week 16 of the study period.ResultsThe reduction in HbA1c at week 16 was significantly higher in arm X than in arm Y [estimated treatment difference (ETD), - 0.65% (95% CI - 0.76 to - 0.53; P < 0.0001)]. Arm X showed a marked decrease in FPG [ETD - 15.42 mg/dl; 95% CI (17.63, 13.22; P < 0.0001)], PPG [ETD - 30.39 mg/dl; 95% CI (35.59, 25.19; P < 0.0001)], and weight [ETD - 1.47 kg; 95% CI (1.59, 1.28; P < 0.0001)] after 16 weeks. In arm X, 54% of patients reached HbA1c < 7.0% compared to 29.9% in arm Y. The incidence of adverse events was comparable [13.14% (arm X) vs 12.4% (arm Y)]. There was no severe hypoglycemia-led treatment discontinuation.ConclusionAmong patients with T2DM who have poor glycemic control with metformin monotherapy, triple FDC (Dapa + Sita + Met) effectively helped achieve better glycemic response compared to dual FDC (Sita + Met), with a comparable safety and tolerability profile.Trial registrationCTRI/2022/01/039857.

Project description:BackgroundEffective glycemic control can reduce the risk of serious micro- and macrovascular complications in type 2 diabetes. However, many patients fail to reach glycemic targets due partly to low efficacy and adverse effects of treatment such as hypoglycemia or weight gain.ObjectiveTo evaluate the short-term cost-effectiveness of liraglutide versus sitagliptin, in terms of cost per patient reaching a glycated hemoglobin (HbA1c) target with no hypoglycemia and no weight gain after 52 weeks, based on a recently published trial. MethodsData were taken from a 52-week randomized, controlled trial (NCT00700817) in which adults with type 2 diabetes (mean age = 55 years, HbA1c = 8.4%, body mass index = 33 kg/m2) failing metformin monotherapy were randomly allocated to receive either liraglutide 1.2 mg, liraglutide 1.8 mg, or sitagliptin 100 mg daily, in addition to metformin. For the cost-effectiveness analysis, the proportion of patients achieving a clinically relevant composite endpoint, defined as HbA1c less than 7.0%, with no reported hypoglycemia  and no gain in body weight, was estimated using logistic regression. Trial data showed that 38.9% of patients on liraglutide 1.2 mg and 49.9% on liraglutide 1.8 mg achieved the composite endpoint, compared with 18.6% on sitagliptin at 52 weeks. Costs of antihyperglycemia medications were accounted for based on published wholesale acquisition costs in 2012 U.S. dollars. ResultsOverall pharmacy costs (needle costs included) were higher for patients on liraglutide than sitagliptin. The cost per patient achieving an HbA1c less than 7% was lowest for patients receiving liraglutide 1.2 mg ($7,993) and highest for patients receiving sitagliptin ($11,570). When expressed as the mean cost per patient reaching target HbA1c with no hypoglycemia or weight gain (cost of control), costs were notably lower on liraglutide than on sitagliptin. Annual mean costs of control were $10,335 on liraglutide 1.2 mg and $11,755 on liraglutide 1.8 mg versus $16,858 on sitagliptin.ConclusionThe mean cost per patient achieving control, defined as reaching HbA1c target with no hypoglycemia or weight gain, was lower with liraglutide than with sitagliptin based on data from a recently published 52-week clinical trial.

Dataset Information

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.

Aim

Methods

Results

Conclusion

Publications

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.

Similar Datasets

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