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

Conditions

• Diabetes
• Diabetes Mellitus, Type 1

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• liraglutide — DRUG
  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 — DRUG
  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 — DRUG
  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.
• placebo — DRUG
  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.
• placebo — DRUG
  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.
• placebo — DRUG
  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.

Study Details

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.

Key Dates

Start date

May 31, 2014

Status verified

Dec 2016

Primary completion

Apr 30, 2015

Completion

Apr 30, 2015

Study Design

Enrollment

835 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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 Outcome Measure

Change From Baseline in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ]

Locations (47)

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