Liraglutide as add-on to Insulin in Type 1 Diabetes

Sponsor
Hvidovre University Hospital
Study ID
NCT02092896
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.
  • Placebo — DRUG
    Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.
  • Liraglutide — DRUG
    Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.
  • Placebo — DRUG
    Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.

Study Details

The purpose of this study is to: Part 1: To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia. Part 2: To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects counterregulatory hormones and cognitive performance during hypoglycemia.

Key Dates

Start date
Mar 31, 2013
Status verified
Mar 2015
Primary completion
Oct 31, 2014
Completion
Oct 31, 2014

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo + Insulin + Study 2
    Study 2: Cognitive performance test
  • Experimental: Liraglutide + Insulin + Study 2
    Study 2: Cognitive performance test
  • Experimental: Liraglutide + Insulin + Study 1
    Study 1: Gastric emptying test
  • Placebo Comparator: Placebo + Insulin + Study 1
    Study 1: Gastric emptying test

Primary Outcome Measure

Change from baseline in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 12 ]

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