Liraglutide as add-on to Insulin in Type 1 Diabetes

Last updated: March 31, 2015
Sponsor: Hvidovre University Hospital
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 1

Diabetes Prevention

Diabetic Gastroparesis

Treatment

N/A

Clinical Study ID

NCT02092896
2012-002526-67
2012-002526-67
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: 18-70 years

  • BMI: 18-28

  • HbA1c ≥ 8 %

  • No residual β-cell function (glucagon test with c-peptide < 60 pM)

  • Caucasian

  • Diagnosed with type 1 diabetes at 5 to 40 years of age (both inclusive).

  • Remission phase must be completed

  • Female participants must use adequate contraception

  • Informed consent

Exclusion

Exclusion Criteria:

  • Overt diabetes complications; creatinin > 130 µM, proliferative retinopathy,macroalbuminuria.

  • Autonomic neuropathy (RR-variation </=10 beats/min) and/or Orthostatic hypotension (OH).

  • Anemia, Hb concentration; female <7.0 mmol/l, male<8.0 mmol/l

  • Pregnancy or lactation

  • Epilepsy

  • Use of antiepileptic medication

  • Use of beta blockers

  • Previously apoplexy cerebri.

  • Any use of benzodiazepine within the last month

  • Any use of neuroleptic drugs within the last six months

  • Self-perceived hearing loss

  • Alcohol or drug abuse

  • Allergy to the medication or placebo.

  • Treatment with any medication affecting glucose metabolism.

  • Any disorder which in the investigators opinion could interfere with the safety andresults of the trial

Study Design

Total Participants: 40
Study Start date:
March 01, 2013
Estimated Completion Date:
October 31, 2014

Connect with a study center

  • Dept. of Endocrinology, Hvidovre University Hospital

    Hvidovre, Copenhagen 2650
    Denmark

    Site Not Available

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