LivingGLP1
Study S002361

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

Included trial: extracted dataClinicalTrials.gov record

Registration

Registration
NCT00700817
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
NONE
Status
COMPLETED
Enrollment
665
Start
2008-06
Primary completion
2009-06
Lead sponsor
Novo Nordisk A/S
Conditions
Diabetes; Diabetes Mellitus, Type 2
Interventions
DRUG:liraglutide; DRUG:sitagliptin; DRUG:metformin
Results posted
TRUE
Secondary identifiers
EUDRACT_NUMBER:2007-003937-17

Registered primary outcomes

  • Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 [Week 0, Week 26]
  • Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 [Week 0, Week 52]
  • Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78 [Week 0, Week 78]
  • Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78 [Week 52, Week 78]

Linked records (16)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0012795Efficacy and safety of liraglutide, a once-daily human glucagon-like peptide-1 analogue, in Latino/Hispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials.
Davidson JA, Diabetes, obesity & metabolism
2016Systematic reviewPMID 26936426DOIregistry reference RESULT:26936426
R0023483Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials.
Jensen TM, Diabetes care
2015Systematic reviewPMID 25504028DOIregistry reference RESULT:25504028
R0016483Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme.
Niswender K, Diabetes, obesity & metabolism
2013Randomized trialPMID 22862847DOIregistry reference RESULT:22862847
R0017412Incretin therapy for type 2 diabetes in Spain: a cost-effectiveness analysis of liraglutide versus sitagliptin.
Mezquita Raya P, Diabetes therapy : research, treatment and education of diabetes and related disorders
2013Randomized trialPMID 24132613DOIcites ClinicalTrials.gov:NCT00700817
R0023531Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%.
King AB, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
2013OtherPMID 23186975DOIregistry reference RESULT:23186975
R0026674Evaluating the short-term cost-effectiveness of liraglutide versus sitagliptin in patients with type 2 diabetes failing metformin monotherapy in the United States.
Langer J, Journal of managed care pharmacy : JMCP
2013Randomized trialPMID 23537458DOIcites ClinicalTrials.gov:NCT00700817; registry reference DERIVED:23537458
R0020069A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer.
Alves C, Diabetes research and clinical practice
2012Systematic reviewPMID 23010561DOIregistry reference RESULT:23010561
R0022006Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme.
Zinman B, Diabetes, obesity & metabolism
2012Systematic reviewPMID 21883806DOIregistry reference RESULT:21883806
R0023916Efficacy and safety of switching from the DPP-4 inhibitor sitagliptin to the human GLP-1 analog liraglutide after 52 weeks in metformin-treated patients with type 2 diabetes: a randomized, open-label trial.
Pratley RE, Diabetes care
2012Randomized trialPMID 22851600DOIregistry reference RESULT:22851600
R0026899Long-term clinical and economic outcomes associated with liraglutide versus sitagliptin therapy when added to metformin in the treatment of type 2 diabetes: a CORE Diabetes Model analysis.
Lee WC, Journal of medical economics
2012Other trialPMID 22834986DOIregistry reference RESULT:22834986
R0026951Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus.
Davies MJ, Diabetic medicine : a journal of the British Diabetic Association
2012Other trialPMID 21883438DOIregistry reference RESULT:21883438
R0024199One 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, International journal of clinical practice
2011Randomized trialPMID 21355967DOIcites ClinicalTrials.gov:NCT00700817; registry reference RESULT:21355967
R0025273Liraglutide improves treatment satisfaction in people with Type 2 diabetes compared with sitagliptin, each as an add on to metformin.
Davies M, Diabetic medicine : a journal of the British Diabetic Association
2011Randomized trialPMID 21309842DOIregistry reference RESULT:21309842
R0025876Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program.
Henry RR, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
2011Systematic reviewPMID 22193143DOIregistry reference RESULT:22193143
R0025739Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial.
Pratley RE, Lancet (London, England)
2010Randomized trialPMID 20417856DOIcites ClinicalTrials.gov:NCT00700817; registry reference RESULT:20417856
R0035671Recent Data from LEAD
Daniel S. Gordon, MD Conference Express
2010OtherDOIcites ClinicalTrials.gov:NCT00700817