Trial · NCT02098395

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

NCT02098395, Phase 3, Completed, Novo Nordisk A/S; results first posted 2016-06-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes. Trials, record NCT02098395. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02098395

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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 Adjunct to Insulin Treatment in Type 1 Diabetes
NCT number: NCT02098395
Status: Completed
Phases: Phase 3
Enrollment: 835 participants, actual
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes, Diabetes Mellitus, Type 1
Interventions: liraglutide, liraglutide, liraglutide, placebo, placebo, placebo
First posted: 2014-03-28
Last updated: 2017-02-09
Other registries' IDs: eudract:2012-005778-74
Results first posted: 2016-06-03

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Glycosylated Haemoglobin (HbA1c)	Week 0, Week 26	Change from baseline in glycosylated haemoglobin (HbA1c), after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.
Secondary	Change From Baseline in Body Weight	Week 0, Week 26	Change from baseline body weight, after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.
Secondary	Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes	Weeks 0-26	Number of treatment-emergent symptomatic hypoglycaemic episodes during 26 weeks of treatment. Symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or a self-measured plasma glucose (SMPG) value of \<3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification is defined as an episode that required assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.

Source ClinicalTrials.gov

Outcomes3

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 Glycosylated Haemoglobin (HbA1c)	Week 0, Week 26	Out of the 831 subjects in FAS, 22 subjects in lira 0.6 mg arm, 33 subjects in lira 1.2 mg arm, 35 subjects in lira 1.8 mg arm and 16 in placebo arm did not contribute to this analysis. Missing data imputed from a mixed model for repeated measurements (MMRM) method.	Percent (%) glycosylated haemoglobin	MEAN
SECONDARY	Change From Baseline in Body Weight	Week 0, Week 26	Of the 831 subjects in FAS, 27 subjects in lira 0.6 mg arm, 38 subjects in lira 1.2 mg arm, 35 subjects in lira 1.8 mg arm and 26 in placebo arm did not contribute to the analysis. Missing data imputed from a mixed model for repeated measurements (MMRM) method.	kg	MEAN
SECONDARY	Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes	Weeks 0-26	Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo (SAS = 832 subjects). Symptomatic hypoglycaemic episodes were reported by 166 subjects in liraglutide 0.6 mg arm, 175 subjects in liraglutide 1.2 mg, 160 subjects in liraglutide 1.8 mg arm and 162 subjects in liraglutide placebo arm.	episodes	NUMBER

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Glycosylated Haemoglobin (HbA1c)	Liraglutide 0.6 mg	-0.23	Standard Deviation 0.744	Percent (%) glycosylated haemoglobin
Change From Baseline in Glycosylated Haemoglobin (HbA1c)	Liraglutide 1.2 mg	-0.23	Standard Deviation 0.731	Percent (%) glycosylated haemoglobin
Change From Baseline in Glycosylated Haemoglobin (HbA1c)	Liraglutide 1.8 mg	-0.32	Standard Deviation 0.73	Percent (%) glycosylated haemoglobin
Change From Baseline in Glycosylated Haemoglobin (HbA1c)	Liraglutide Placebo	0.01	Standard Deviation 0.674	Percent (%) glycosylated haemoglobin
Change From Baseline in Body Weight	Liraglutide 0.6 mg	-2.37	Standard Deviation 3.015	kg
Change From Baseline in Body Weight	Liraglutide 1.2 mg	-4.03	Standard Deviation 3.677	kg
Change From Baseline in Body Weight	Liraglutide 1.8 mg	-5.1	Standard Deviation 3.787	kg
Change From Baseline in Body Weight	Liraglutide Placebo	-0.26	Standard Deviation 2.782	kg
Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes	Liraglutide 0.6 mg	1437		episodes
Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes	Liraglutide 1.2 mg	1943		episodes

1 to 10 of 12Source ClinicalTrials.gov

See all 12 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	212
Overall Study	STARTED	Liraglutide 1.2 mg	209
Overall Study	STARTED	Liraglutide 1.8 mg	207
Overall Study	STARTED	Liraglutide Placebo	207
Overall Study	Exposed	Liraglutide 0.6 mg	211
Overall Study	Exposed	Liraglutide 1.2 mg	209
Overall Study	Exposed	Liraglutide 1.8 mg	206
Overall Study	Exposed	Liraglutide Placebo	206
Overall Study	COMPLETED	Liraglutide 0.6 mg	186
Overall Study	COMPLETED	Liraglutide 1.2 mg	177

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events288

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 discomfort	Gastrointestinal disorders	Liraglutide 0.6 mg	3	211	4
other	Abdominal discomfort	Gastrointestinal disorders	Liraglutide 1.2 mg	14	209	18
other	Abdominal discomfort	Gastrointestinal disorders	Liraglutide 1.8 mg	7	206	7
other	Abdominal discomfort	Gastrointestinal disorders	Liraglutide Placebo	6	206	7
other	Abdominal pain upper	Gastrointestinal disorders	Liraglutide 0.6 mg	8	211	8
other	Abdominal pain upper	Gastrointestinal disorders	Liraglutide 1.2 mg	8	209	13
other	Abdominal pain upper	Gastrointestinal disorders	Liraglutide 1.8 mg	14	206	17
other	Abdominal pain upper	Gastrointestinal disorders	Liraglutide Placebo	5	206	5
other	Constipation	Gastrointestinal disorders	Liraglutide 0.6 mg	6	211	6
other	Constipation	Gastrointestinal disorders	Liraglutide 1.2 mg	23	209	29

1 to 10 of 288Source ClinicalTrials.gov

See all 288 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	Liraglutide Placebo
Total, other adverse events	Liraglutide 0.6 mg	137	211
Total, other adverse events	Liraglutide 1.2 mg	164	209
Total, other adverse events	Liraglutide 1.8 mg	162	206
Total, other adverse events	Liraglutide Placebo	125	206
Total, serious adverse events	Liraglutide 0.6 mg	20	211
Total, serious adverse events	Liraglutide 1.2 mg	21	209

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27493132	RESULT	PubMed
27493232	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/NCT02098395

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