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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name ADJUNCT TWO™

NCTNCT02098395 (opens ClinicalTrials.gov in a new tab)Other idNN9211-4083Other id2012-005778-74Other idU1111-1138-0619Other idNL47705.060.14
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
835 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
13 countries

United States, Austria, Belgium, Bulgaria, Canada, Denmark, Finland, France, Italy, Netherlands, South Africa, Spain, Sweden

Start
May 2014
Primary completion
Apr 2015
Completion
Apr 2015
First posted
28 Mar 2014 (estimated)
Last update posted
9 Feb 2017 (estimated)
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
201420152016
  1. Ph 3

    ADJUNCT TWO™

    NCT02098395

    May 2014 to Apr 2015

Registry summary

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

This trial is conducted in Africa, Europe and North America. The purpose of the trial is to investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes.

Interventions

  • liraglutideDrug
  • liraglutideDrug
  • liraglutideDrug
  • placeboDrug
  • placeboDrug
  • placeboDrug

Arms6

  • Experimental

    Liraglutide 1.8 mg + insulin

  • Experimental

    Liraglutide 1.2 mg + insulin

  • Experimental

    Liraglutide 0.6 mg + insulin

  • Placebo comparator

    Liraglutide placebo 0.3 ml + insulin

  • Placebo comparator

    Liraglutide placebo 0.2 ml + insulin

  • Placebo comparator

    Liraglutide placebo 0.1 ml + insulin

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Glycosylated Haemoglobin (HbA1c)

    Time frame · Week 0, Week 26

    Registry description

    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 outcomes(2)

  1. Change From Baseline in Body Weight

    Time frame · Week 0, Week 26

    Registry description

    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.

  2. Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes

    Time frame · Weeks 0-26

    Registry description

    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.

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 26

Change From Baseline in Glycosylated Haemoglobin (HbA1c)

GroupValue (Percent (%) glycosylated haemoglobin)Spread
Liraglutide 0.6 mg-0.230.744
Liraglutide 1.2 mg-0.230.731
Liraglutide 1.8 mg-0.320.73
Liraglutide Placebo0.010.674
Secondary and other outcome results(2)
Secondary outcomeMean· Week 0, Week 26

Change From Baseline in Body Weight

GroupValue (kg)Spread
Liraglutide 0.6 mg-2.373.015
Liraglutide 1.2 mg-4.033.677
Liraglutide 1.8 mg-5.13.787
Liraglutide Placebo-0.262.782
Secondary outcomeNumber· Weeks 0-26

Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes

GroupValue (episodes)
Liraglutide 0.6 mg1437
Liraglutide 1.2 mg1943
Liraglutide 1.8 mg1490
Liraglutide Placebo1567

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Liraglutide 0.6 mgSubjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.–20 / 211137 / 211
Liraglutide 1.2 mgSubjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.–21 / 209164 / 209
Liraglutide 1.8 mgSubjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.–14 / 206162 / 206
Liraglutide PlaceboSubjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis. 1. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial. 2. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks. 3. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.–14 / 206125 / 206

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 linkSee results (13)

Indexing hint: Randomized controlled trial · 2016

10 results

Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial.

Ahrén et al. 2016Diabetes carecited by 212

PMID 27493132DOI 10.2337/dc16-0690PUB-27493132

Full text at the publisher10 results
Publisher pageSee results (10)

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 sourceRead the notice

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultHoogenhout M, Malcolm-Smith S. Theory of mind predicts severity level in autism. Autism. 2017 Feb;21(2):242-252. doi: 10.1177/1362361316636758. Epub 2016 Aug 19. PMID 27493232

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 before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Male or female, aged equal to or greater than 18 years at the time of signing informed consent * Type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to Visit 1 (i.e. screening) * Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin pump) treatment 6 months or longer prior to Visit 1 (i.e. screening) * Stable insulin treatment 3 months or longer prior to Visit 1 (i.e. screening), as judged and documented by the investigator * HbA1c 7.0-10.0 percent (Diabetes Control and Complications Trial (DCCT)), both inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC)) Exclusion Criteria: * Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPPIV) inhibitors * Use of any medication, which in the investigator's opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) 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 (Visit 1) (after resting for 5 minutes) while sitting greater than 160 mmHg for systolic or greater than 100 mmHg for diastolic (repeated measurement at Visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension) * History of acute or chronic pancreatitis * Screening (Visit 1) calcitonin value equal to or greater than 50 ng/L

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