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

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: placebo; Drug: liraglutide

• Registration Number: NCT01836523
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-22
• Study Start: 2013-11
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2016-05-23
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-16
• Last Update Submitted: 2017-01-16
• Results First Posted: 2017-03-06
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1398

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liraglutide placebo 1.8 mg + insulin	placebo	-
Liraglutide placebo 0.6 mg + insulin	placebo	-
Liraglutide placebo 1.2 mg + insulin	placebo	-
Liraglutide 0.6 mg + insulin	liraglutide	-
Liraglutide 1.2 mg + insulin	liraglutide	-
Liraglutide 1.8 mg + insulin	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (Glycosylated Haemoglobin)	Week 0, week 52	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	Week 0, week 52	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	Week 0, week 52	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 Outcome Measures

Name	Time	Method
Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes	Weeks 0-52	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.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Stevenage, United Kingdom