Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00700817Other idNN2211-1860Other id2007-003937-17

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 665 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Open label (no masking)
Countries: 15 countries
United States, Canada, Croatia, France, Germany, Ireland, Italy, Netherlands, Puerto Rico, Romania, Serbia and Montenegro, Slovakia, Slovenia, Spain, United Kingdom
Start: Jun 2008
Primary completion: Jun 2009
Completion: Jun 2010
First posted: 19 Jun 2008 (estimated)
Last update posted: 8 Mar 2017
Conditions: Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2008200920102011

Ph 3
The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus
NCT00700817
Jun 2008 to Jun 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

liraglutideDrug
sitagliptinDrug
metforminDrug
liraglutideDrug

Arms5

Experimental
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).
Experimental
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).
Active comparator
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).
Experimental
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.
Experimental
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.

Primary outcomes4

Outcomes the sponsor listed as primary.

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26
Time frame · Week 0, Week 26
Registry description
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
Time frame · Week 0, Week 52
Registry description
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78
Time frame · Week 0, Week 78
Registry description
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78
Time frame · Week 52, Week 78
Registry description
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78

Secondary outcomes(20)

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26
Time frame · Week 0, Week 26
Registry description
Calculated as the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 26
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52
Time frame · Week 0, Week 52
Registry description
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 52
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Time frame · Week 0, Week 78
Registry description
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 78. Based on the FAS.
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Time frame · Week 0, Week 78
Registry description
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 78. Based on the extension 2 FAS.
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26
Time frame · Week 0, Week 26
Registry description
Calculated as the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 26
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52
Time frame · Week 0, Week 52
Registry description
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 52
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
Time frame · Week 0, Week 78
Registry description
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 78. Based on the FAS.
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
Time frame · Week 0, Week 78
Registry description
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 78. Based on the extension 2 FAS.
Mean Change From Baseline in Body Weight at Week 26
Time frame · Week 0, Week 26
Registry description
Calculated as an estimate of the mean change from baseline in body weight at Week 26.
Mean Change From Baseline in Body Weight at Week 52
Time frame · Week 0, Week 52
Registry description
Calculated as an estimate of the mean change from baseline in body weight at Week 52.
Mean Change in Body Weight From Week 52 to Week 78
Time frame · Week 52, Week 78
Registry description
Mean change in body weight from Week 52 to Week 78.
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Time frame · Week 0, Week 26
Registry description
Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Time frame · Week 0, Week 52
Registry description
Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78
Time frame · Week 0, Week 78
Registry description
Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.
Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78
Time frame · Week 52, Week 78
Registry description
Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.
Mean Change From Baseline in Beta-cell Function at Week 26
Time frame · Week 0, Week 26
Registry description
Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Mean Change From Baseline in Beta-cell Function at Week 52
Time frame · Week 0, Week 52
Registry description
Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Mean Change in Beta-cell Function From Week 52 to Week 78
Time frame · Week 52, Week 78
Registry description
Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Mean Change From Baseline in Total Cholesterol at Week 26
Time frame · Week 0, Week 26
Registry description
Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.
Mean Change From Baseline in Total Cholesterol at Week 52
Time frame · Week 0, Week 52
Registry description
Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Week 0, Week 26

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26

Group	Value (Percentage point of total HbA1c)	Spread
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.24	0.07
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-1.5	0.06
Sita -> Sita	-0.9	0.07
Sita -> Sita -> Lira 1.2 mg	not posted	–
Sita -> Sita -> Lira 1.8 mg	not posted	–

Primary outcomeLeast squares mean· Week 0, Week 52

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52

Group	Value (Percentage point of total HbA1c)	Spread
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-1.29	0.07
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-1.51	0.07
Sita -> Sita	-0.88	0.07
Sita -> Sita -> Lira 1.2 mg	not posted	–
Sita -> Sita -> Lira 1.8 mg	not posted	–

Primary outcomeLeast squares mean· Week 0, Week 78

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78

Group	Value (Percentage point of total HbA1c)	Spread
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	-0.94	0.08
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	-1.28	0.07
Sita -> Sita	not posted	–
Sita -> Sita -> Lira 1.2 mg	not posted	–
Sita -> Sita -> Lira 1.8 mg	not posted	–

Primary outcomeMean· Week 52, Week 78

Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78

Group	Value (Percentage point of total HbA1c)	Spread
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	not posted	–
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	not posted	–
Sita -> Sita	not posted	–
Sita -> Sita -> Lira 1.2 mg	-0.24	0.7
Sita -> Sita -> Lira 1.8 mg	-0.45	0.9

Secondary and other outcome results(4)

Secondary outcomeNumber· Week 0, Week 26

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26

Group	Value (percentage of subjects)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	43
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	55
Sita -> Sita	22
Sita -> Sita -> Lira 1.2 mg	not posted
Sita -> Sita -> Lira 1.8 mg	not posted

Secondary outcomeNumber· Week 0, Week 52

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52

Group	Value (percentage of subjects)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	50
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	63
Sita -> Sita	27
Sita -> Sita -> Lira 1.2 mg	not posted
Sita -> Sita -> Lira 1.8 mg	not posted

Secondary outcomeNumber· Week 0, Week 78

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

Group	Value (percentage of subjects)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	35
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	51
Sita -> Sita	not posted
Sita -> Sita -> Lira 1.2 mg	not posted
Sita -> Sita -> Lira 1.8 mg	not posted

Secondary outcomeNumber· Week 0, Week 78

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

Group	Value (percentage of subjects)
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg	not posted
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg	not posted
Sita -> Sita	not posted
Sita -> Sita -> Lira 1.2 mg	49
Sita -> Sita -> Lira 1.8 mg	50

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgOnce-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).	–	12 / 221	120 / 221
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgOnce-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).	–	19 / 218	134 / 218
Sita -> SitaOnce-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).	–	17 / 219	106 / 219

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies14

Studies that cite this trial.

Studies with results

11 studies on this page

Indexing hint: Meta-analysis (pooled) · 2016

6 results

Efficacy 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 et al. 2016Diabetes, obesity & metabolismcited by 12

PMID 26936426DOI 10.1111/dom.12653PUB-26936426

Rights unknown6 results

Source link See results (6)

Indexing hint: Randomized controlled trial · 2013

8 results

Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme.

Niswender et al. 2013Diabetes, obesity & metabolismcited by 75

PMID 22862847DOI 10.1111/j.1463-1326.2012.01673.xPUB-22862847

Full text at the publisher8 results

Publisher page See results (8)

Indexing hint: Observational study · 2013

2 results

Evaluating the short-term cost-effectiveness of liraglutide versus sitagliptin in patients with type 2 diabetes failing metformin monotherapy in the United States.

Langer et al. 2013Journal of managed care pharmacy : JMCPcited by 30

PMID 23537458PMC10438006DOI 10.18553/jmcp.2013.19.3.237PUB-23537458

Rights unknown2 results

Source link See results (2)

Indexing hint: Observational study · 2012

12 results

Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus.

Davies et al. 2012Diabetic medicine : a journal of the British Diabetic Associationcited by 37

PMID 21883438PMC3378710DOI 10.1111/j.1464-5491.2011.03429.xPUB-21883438

CC BY12 results

Download PDF See results (12)

Indexing hint: Meta-analysis (pooled) · 2012

3 results

Achieving 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 et al. 2012Diabetes, obesity & metabolismcited by 81

PMID 21883806DOI 10.1111/j.1463-1326.2011.01493.xPUB-21883806

Full text at the publisher3 results

Publisher page See results (3)

Indexing hint: Observational study · 2012

3 results

Long-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 et al. 2012Journal of medical economicscited by 22

PMID 22834986DOI 10.3111/13696998.2012.716111PUB-22834986

Full text at the publisher3 results

Publisher page See results (3)

Indexing hint: Randomized controlled trial · 2012

17 results

Efficacy 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 et al. 2012Diabetes carecited by 52

PMID 22851600PMC3447855DOI 10.2337/dc11-2113PUB-22851600

Free to read · publisher termsCC BY-NC-ND17 results

Read at source See results (17)

Indexing hint: Meta-analysis (pooled) · 2012

3 results

A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer.

Alves et al. 2012Diabetes research and clinical practicecited by 142

PMID 23010561DOI 10.1016/j.diabres.2012.09.008PUB-23010561

Full text at the publisher3 results

Publisher page See results (3)

Indexing hint: Randomized controlled trial · 2011

5 results

Liraglutide improves treatment satisfaction in people with Type 2 diabetes compared with sitagliptin, each as an add on to metformin.

Davies et al. 2011Diabetic medicine : a journal of the British Diabetic Associationcited by 46

PMID 21309842DOI 10.1111/j.1464-5491.2010.03074.xPUB-21309842

Full text at the publisher5 results

Publisher page See results (5)

Indexing hint: 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 et al. 2011International journal of clinical practicecited by 193

PMID 21355967PMC3085127DOI 10.1111/j.1742-1241.2011.02656.xPUB-21355967

CC BY8 results

Download PDF See results (8)

Indexing hint: Meta-analysis (pooled) · 2011

4 results

Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program.

Henry et al. 2011Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 42

PMID 22193143DOI 10.4158/ep.17.6.906PUB-22193143

Full text at the publisher4 results

Publisher page See results (4)

More studies

3 studies on this page

Indexing hint: Meta-analysis (pooled) · 2015

Corrected

Is 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 et al. 2015Diabetes carecited by 45

PMID 25504028DOI 10.2337/dc13-1210PUB-25504028

Rights unknown

Source link Read the notice

PubMed tag: none · 2013

Liraglutide 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 et al. 2013Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 14

PMID 23186975DOI 10.4158/ep12232.orPUB-23186975

Full text at the publisher

Publisher page

Indexing hint: Randomized controlled trial · 2010

Corrected

Liraglutide 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 et al. 2010Lancet (London, England)cited by 429

PMID 20417856DOI 10.1016/s0140-6736(10)60307-8PUB-20417856

Full text at the publisher

Publisher page Read the notice

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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