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Completed

NCT Number: NCT02092896

Liraglutide as add-on to Insulin in Type 1 Diabetes

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Hypoglycemia Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dept. of Endocrinology, Hvidovre University Hospital

Hvidovre, Copenhagen, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 and results of the trial

Treatment and study plan

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.

Primary outcomes

  1. Change from baseline in HbA1c (glycosylated haemoglobin)

    Time frame: Week 0, week 12

  2. Changes from baseline in EEG and cognitive performances

    Time frame: week 0, week 12

  3. Change from baseline in gastric emptying rate

    Time frame: week 0, week 12

Secondary outcomes

  1. Change from baseline in glycemic control (CGM)

    Time frame: week 0, week 12

  2. Change from baseline in total daily insulin dose

    Time frame: week 0, week 12

  3. Changes from baseline in the counterregulatory hormone responses during hypoglycemia

    Time frame: week 0, week 12

  4. Change from baseline in body weight

    Time frame: week 0, week 12

  5. Change from baseline in auditory evoked potentials (AEP) during hypoglycemia

    Time frame: week 0, week 12

  6. Change from baseline in corrected QTc-interval (QTc) during hypoglycemia

    Time frame: week 0, week 12

  7. Change from baseline in hypoglycemic symptom score

    Time frame: week 0, week 12

Other outcomes

  1. Frequency of Hypoglycemic episodes

    Time frame: Week 0, week 12

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Danish PhD schools of Molecular Metabolism and Endocrinology
  • Hillerod Hospital, Denmark
  • NNF Center for Basal Metabolic Research, Denmark
  • Novo Nordisk A/S

Registry information

Official study title

Treatment With Liraglutide as add-on to Insulin in Type 1 Diabetic Patients. Effects on Glycemic Control and Counterregulation and Cognitive Performance During Hypoglycaemia

Acronym: T1DMLIRA

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 20, 2014
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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