NCT02098395|CompletedPhase 3Results

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

ADJUNCT TWO™

A 26-weeks Randomised, Insulin Capped, Placebo-controlled, Double-blind, Parallel Group, Multinational, Multi-centre Trial

Novo Nordisk A/S ClinicalTrials.gov

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5 other identifiers

NN9211-40832012-005778-74U1111-1138-0619NL47705.060.14REec-2014-0884

Study Type

interventional

Target

835

Locations

13 countries

Sites

120

Timeline

RegisteredMar 2014

StartedMay 2014

CompletionApr 2015

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

835

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started May 2014

Shorter than P25 for phase_3 diabetes

Geographic Reach

13 countries

120 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

First Submitted

Initial submission to the registry

March 25, 2014

Completed

3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed

1 month until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

June 3, 2016

Completed

Last Updated

February 9, 2017

Status Verified

December 1, 2016

Enrollment Period

11 months

First QC Date

March 25, 2014

Results QC Date

April 26, 2016

Last Update Submit

December 15, 2016

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Glycosylated Haemoglobin (HbA1c)
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.
Week 0, Week 26

Secondary Outcomes (2)

Change From Baseline in Body Weight
Week 0, Week 26
Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes
Weeks 0-26

Study Arms (6)

Liraglutide 1.8 mg + insulin

EXPERIMENTAL

Drug: liraglutide

Liraglutide 1.2 mg + insulin

EXPERIMENTAL

Drug: liraglutide

Liraglutide 0.6 mg + insulin

EXPERIMENTAL

Drug: liraglutide

Liraglutide placebo 0.3 ml + insulin

PLACEBO COMPARATOR

Drug: placebo

Liraglutide placebo 0.2 ml + insulin

PLACEBO COMPARATOR

Drug: placebo

Liraglutide placebo 0.1 ml + insulin

PLACEBO COMPARATOR

Drug: placebo

Interventions

liraglutideDRUG

Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.

Liraglutide 1.8 mg + insulin

placeboDRUG

Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.

Liraglutide placebo 0.3 ml + insulin

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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))

You may not qualify if:

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

Contact the study team to confirm eligibility.