Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name ADJUNCT ONE™

NCTNCT01836523Other idNN9211-3919Other id2012-003580-21Other idU1111-1133-0590

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 1,398 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Double masking
Countries: 17 countries
United States, Argentina, Australia, Belgium, Canada, Finland, France, Germany, Ireland, Israel, Netherlands, Norway, Poland, Russia, Sweden, Ukraine, United Kingdom
Start: Nov 2013
Primary completion: Jun 2015
Completion: Jun 2015
First posted: 22 Apr 2013 (estimated)
Last update posted: 6 Mar 2017
Conditions: Diabetes · Diabetes Mellitus, Type 1

Timeline

1 trial · 1 completed · 1 with posted results

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

2013201420152016

Ph 3
ADJUNCT ONE™
NCT01836523
Nov 2013 to Jun 2015

Registry summary

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

This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total trial duration per subject is approximately 58 weeks.

Interventions

liraglutideDrug
placeboDrug
liraglutideDrug
placeboDrug
liraglutideDrug
placeboDrug

Arms6

Experimental
Liraglutide 0.6 mg + insulin
Experimental
Liraglutide 1.2 mg + insulin
Experimental
Liraglutide 1.8 mg + insulin
Placebo comparator
Liraglutide placebo 0.6 mg + insulin
Placebo comparator
Liraglutide placebo 1.2 mg + insulin
Placebo comparator
Liraglutide placebo 1.8 mg + insulin

Primary outcomes3

Outcomes the sponsor listed as primary.

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Time frame · Week 0, week 52
Registry description
Change from baseline in HbA1c at week 52. Missing values were handled by using a mixed model for repeated measurements (MMRM).
Change From Baseline in Body Weight
Time frame · Week 0, week 52
Registry description
Change from baseline in body weight at week 52. Missing values were handled by using a MMRM.
Change From Baseline in Total Daily Insulin Dose
Time frame · Week 0, week 52
Registry description
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 outcomes(1)

Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes
Time frame · Weeks 0-52
Registry description
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.

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 outcomeMean· Week 0, week 52

Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Group	Value (percentage of glycosylated haemoglobin)	Spread
Liraglutide 0.6 mg	-0.45	0.741
Liraglutide 1.2 mg	-0.50	0.767
Liraglutide 1.8 mg	-0.54	0.729
Placebo	-0.34	0.707

Primary outcomeMean· Week 0, week 52

Change From Baseline in Body Weight

Group	Value (kg)	Spread
Liraglutide 0.6 mg	-1.34	4.183
Liraglutide 1.2 mg	-2.73	4.524
Liraglutide 1.8 mg	-4.02	4.873
Placebo	0.94	3.828

Primary outcomeGeometric mean· Week 0, week 52

Change From Baseline in Total Daily Insulin Dose

Group	Value (ratio)	Spread
Liraglutide 0.6 mg	1.04	23.75
Liraglutide 1.2 mg	0.98	26.66
Liraglutide 1.8 mg	0.95	24.21
Placebo	1.04	26.69

Secondary and other outcome results(1)

Secondary outcomeNumber· Weeks 0-52

Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes

Group	Value (episodes)
Liraglutide 0.6 mg	4954
Liraglutide 1.2 mg	4602
Liraglutide 1.8 mg	4614
Placebo	3654

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Liraglutide 0.6 mgSubjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.	–	35 / 350	259 / 350
Liraglutide 1.2 mgSubjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.	–	36 / 348	263 / 348
Liraglutide 1.8 mgLiraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.	–	29 / 347	282 / 347
PlaceboSubjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.	–	38 / 348	224 / 348

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

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2025

13 results

Determinants of Liraglutide Treatment Discontinuation in Type 1 Diabetes: A Post Hoc Analysis of ADJUNCT ONE and ADJUNCT TWO Randomized Placebo-Controlled Clinical Studies.

Shah et al. 2025Journal of diabetes science and technologycited by 8

PMID 39717993PMC11669135DOI 10.1177/19322968241305647PUB-39717993

Rights unknown13 results

Source link See results (13)

Indexing hint: Randomized controlled trial · 2016

14 results

Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial.

Mathieu et al. 2016Diabetes carecited by 270

PMID 27506222DOI 10.2337/dc16-0691PUB-27506222

Full text at the publisher14 results

Publisher page See results (14)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2021

Corrected

Efficacy and safety of liraglutide in type 1 diabetes by baseline characteristics in the ADJUNCT ONE and ADJUNCT TWO randomized controlled trials.

Dejgaard et al. 2021Diabetes, obesity & metabolismcited by 43

PMID 34463425PMC9292057DOI 10.1111/dom.14532PUB-34463425

Free to read · publisher termsCC BY-NC

Read at source Read the notice

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * \- Informed consent obtained * \- Type 1 diabetes mellitus for 12 months or longer * \- Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment for 6 months or longer * \- Stable insulin treatment for the last 3 months prior to Screening, as judged and documented by the investigator * \- HbA1c 7.0-10% (Diabetes Control and Complications Trial (DCCT)), both inclusive, (corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC)) * \- Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, complete trial related questionnaires, diaries, self-monitoring of plasma glucose, self titration of insulin and attend all scheduled visits Exclusion Criteria: * \- Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPP-4) inhibitors * \- Use of any medication, which in the investigator's opinion could interfere with the glycaemic control or affect the subject's safety.Premix insulin is not allowed * \- Known proliferative retinopathy or maculopathy requiring acute treatment * \- Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator * \- Uncontrolled/ untreated blood pressure at screening above 160 mmHg for systolic or above 100 mmHg for diastolic * \- History of acute or chronic pancreatitis * \- Screening calcitonin value equal to or above 50 ng/L * \- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2) * \- Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)

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