Trial · NCT01836523

The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes

NCT01836523, Phase 3, Completed, Novo Nordisk A/S; results first posted 2017-03-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes. Trials, record NCT01836523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01836523

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes
NCT number: NCT01836523
Status: Completed
Phases: Phase 3
Enrollment: 1,398 participants, actual
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes, Diabetes Mellitus, Type 1
Interventions: liraglutide, placebo, liraglutide, placebo, liraglutide, placebo
First posted: 2013-04-22
Last updated: 2017-03-06
Other registries' IDs: eudract:2012-003580-21
Results first posted: 2017-03-06

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in HbA1c (Glycosylated Haemoglobin)	Week 0, week 52	Change from baseline in HbA1c at week 52. Missing values were handled by using a mixed model for repeated measurements (MMRM).
Primary	Change From Baseline in Body Weight	Week 0, week 52	Change from baseline in body weight at week 52. Missing values were handled by using a MMRM.
Primary	Change From Baseline in Total Daily Insulin Dose	Week 0, week 52	Change from baseline in total daily insulin dose at week 52. Change from baseline was represented in terms of ratio to baseline for insulin dose i.e. Total daily insulin dose at week 52/total daily insulin dose at baseline. Missing values were handled by using a MMRM.
Secondary	Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes	Weeks 0-52	This is a confirmatory secondary endpoint. Symptomatic hypoglycaemic episodes were defined as: 1) Severe according to the American Diabetes Association (ADA) classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. OR 2) Self-monitoring of plasma glucose value of \<3.1 mmol/L, with symptoms consistent with hypoglycaemia. A treatment emergent episode is defined as an episode with onset date (or increase in severity) on or after first day of exposure to randomised treatment and up to last dose + 7 days.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in HbA1c (Glycosylated Haemoglobin)	Week 0, week 52	Full analysis set. Number of subjects analysed=subjects with any post-baseline HbA1c data.	percentage of glycosylated haemoglobin	MEAN
PRIMARY	Change From Baseline in Body Weight	Week 0, week 52	Full analysis set. Number of subjects analysed=subjects with any post-baseline body weight data.	kg	MEAN
PRIMARY	Change From Baseline in Total Daily Insulin Dose	Week 0, week 52	Full analysis set. Number of subjects analysed=subjects with any post-baseline total insulin daily dose data.	ratio	GEOMETRIC_MEAN
SECONDARY	Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes	Weeks 0-52	The safety analysis set included all randomised subjects exposed to at least one dose of liraglutide or placebo.	episodes	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in HbA1c (Glycosylated Haemoglobin)	Liraglutide 0.6 mg	-0.45	Standard Deviation 0.741	percentage of glycosylated haemoglobin
Change From Baseline in HbA1c (Glycosylated Haemoglobin)	Liraglutide 1.2 mg	-0.50	Standard Deviation 0.767	percentage of glycosylated haemoglobin
Change From Baseline in HbA1c (Glycosylated Haemoglobin)	Liraglutide 1.8 mg	-0.54	Standard Deviation 0.729	percentage of glycosylated haemoglobin
Change From Baseline in HbA1c (Glycosylated Haemoglobin)	Placebo	-0.34	Standard Deviation 0.707	percentage of glycosylated haemoglobin
Change From Baseline in Body Weight	Liraglutide 0.6 mg	-1.34	Standard Deviation 4.183	kg
Change From Baseline in Body Weight	Liraglutide 1.2 mg	-2.73	Standard Deviation 4.524	kg
Change From Baseline in Body Weight	Liraglutide 1.8 mg	-4.02	Standard Deviation 4.873	kg
Change From Baseline in Body Weight	Placebo	0.94	Standard Deviation 3.828	kg
Change From Baseline in Total Daily Insulin Dose	Liraglutide 0.6 mg	1.04	Geometric Coefficient of Variation 23.75	ratio
Change From Baseline in Total Daily Insulin Dose	Liraglutide 1.2 mg	0.98	Geometric Coefficient of Variation 26.66	ratio

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Liraglutide 0.6 mg	351
Overall Study	STARTED	Liraglutide 1.2 mg	350
Overall Study	STARTED	Liraglutide 1.8 mg	349
Overall Study	STARTED	Placebo	348
Overall Study	Exposed	Liraglutide 0.6 mg	350
Overall Study	Exposed	Liraglutide 1.2 mg	348
Overall Study	Exposed	Liraglutide 1.8 mg	347
Overall Study	Exposed	Placebo	348
Overall Study	COMPLETED	Liraglutide 0.6 mg	300
Overall Study	COMPLETED	Liraglutide 1.2 mg	265

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events492

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal pain	Gastrointestinal disorders	Liraglutide 0.6 mg	20	350	32
other	Abdominal pain	Gastrointestinal disorders	Liraglutide 1.2 mg	16	348	20
other	Abdominal pain	Gastrointestinal disorders	Liraglutide 1.8 mg	29	347	41
other	Abdominal pain	Gastrointestinal disorders	Placebo	8	348	9
other	Constipation	Gastrointestinal disorders	Liraglutide 0.6 mg	17	350	20
other	Constipation	Gastrointestinal disorders	Liraglutide 1.2 mg	28	348	30
other	Constipation	Gastrointestinal disorders	Liraglutide 1.8 mg	26	347	28
other	Constipation	Gastrointestinal disorders	Placebo	9	348	11
other	Diarrhoea	Gastrointestinal disorders	Liraglutide 0.6 mg	41	350	52
other	Diarrhoea	Gastrointestinal disorders	Liraglutide 1.2 mg	50	348	69

1 to 10 of 492Source ClinicalTrials.gov

See all 492 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Liraglutide 0.6 mg
Total, all-cause mortality	Liraglutide 1.2 mg
Total, all-cause mortality	Liraglutide 1.8 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Liraglutide 0.6 mg	259	350
Total, other adverse events	Liraglutide 1.2 mg	263	348
Total, other adverse events	Liraglutide 1.8 mg	282	347
Total, other adverse events	Placebo	224	348
Total, serious adverse events	Liraglutide 0.6 mg	35	350
Total, serious adverse events	Liraglutide 1.2 mg	36	348

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27506222	RESULT	PubMed
34463425	DERIVED	PubMed
39717993	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01836523

GET https://conductscience.org/api/trials/v1/NCT01836523/events?page=2

API reference For AI assistants