Brief Summary

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.

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

1,398

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Nov 2013

Typical duration for phase_3 diabetes

Geographic Reach

17 countries

182 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

1.6 years study duration

First Submitted

Initial submission to the registry

April 17, 2013

Completed

5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2013

Completed

6 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

March 6, 2017

Completed

Last Updated

March 6, 2017

Status Verified

January 1, 2017

Enrollment Period

1.6 years

First QC Date

April 17, 2013

Results QC Date

May 23, 2016

Last Update Submit

January 16, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (3)

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

Secondary Outcomes (1)

Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes
Weeks 0-52

Study Arms (6)

Liraglutide 0.6 mg + insulin

EXPERIMENTAL

Drug: liraglutide

Liraglutide 1.2 mg + insulin

EXPERIMENTAL

Drug: liraglutide

Liraglutide 1.8 mg + insulin

EXPERIMENTAL

Drug: liraglutide

Liraglutide placebo 0.6 mg + insulin

PLACEBO COMPARATOR

Drug: placebo

Liraglutide placebo 1.2 mg + insulin

PLACEBO COMPARATOR

Drug: placebo

Liraglutide placebo 1.8 mg + insulin

PLACEBO COMPARATOR

Drug: placebo

Interventions

liraglutideDRUG

Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Liraglutide 0.6 mg + insulin

placeboDRUG

Liraglutide placebo 0.6 mg + insulin

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

\- 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

You may not qualify if:

\- 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)

Contact the study team to confirm eligibility.