The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of 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 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.
• placebo — DRUG
  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 — DRUG
  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.
• placebo — DRUG
  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 — DRUG
  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.
• placebo — DRUG
  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.

Study Details

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.

Key Dates

Start date

Nov 30, 2013

Status verified

Jan 2017

Primary completion

Jun 30, 2015

Completion

Jun 30, 2015

Study Design

Enrollment

1,398 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Liraglutide 0.6 mg + insulin
• Experimental: Liraglutide 1.2 mg + insulin
• Experimental: Liraglutide 1.8 mg + insulin
• Placebo Comparator: Liraglutide placebo 0.6 mg + insulin
• Placebo Comparator: Liraglutide placebo 1.2 mg + insulin
• Placebo Comparator: Liraglutide placebo 1.8 mg + insulin

Primary Outcome Measure

Change From Baseline in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 52 ]

Locations (70)

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