Liraglutide as add-on to Insulin in Type 1 Diabetes (T1DMLIRA)

March 31, 2015 updated by: Christan SS Frandsen, MD, Hvidovre University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Hvidovre, Copenhagen, Denmark, 2650
        • Dept. of Endocrinology, Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo + Insulin + Study 2
Study 2: Cognitive performance test
Drug: Liraglutide
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.
Drug: Liraglutide
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.
Experimental: Liraglutide + Insulin + Study 2
Study 2: Cognitive performance test
Drug: Placebo
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.
Drug: Placebo
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.
Experimental: Liraglutide + Insulin + Study 1
Study 1: Gastric emptying test
Drug: Liraglutide
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.
Drug: Liraglutide
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 Comparator: Placebo + Insulin + Study 1
Study 1: Gastric emptying test
Drug: Placebo
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.
Drug: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in HbA1c (glycosylated haemoglobin)
Time Frame: Week 0, week 12
Week 0, week 12
Changes from baseline in EEG and cognitive performances
Time Frame: week 0, week 12
week 0, week 12
Change from baseline in gastric emptying rate
Time Frame: week 0, week 12
week 0, week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in glycemic control (CGM)
Time Frame: week 0, week 12
week 0, week 12
Change from baseline in total daily insulin dose
Time Frame: week 0, week 12
week 0, week 12
Changes from baseline in the counterregulatory hormone responses during hypoglycemia
Time Frame: week 0, week 12
week 0, week 12
Change from baseline in body weight
Time Frame: week 0, week 12
week 0, week 12
Change from baseline in auditory evoked potentials (AEP) during hypoglycemia
Time Frame: week 0, week 12
week 0, week 12
Change from baseline in corrected QTc-interval (QTc) during hypoglycemia
Time Frame: week 0, week 12
week 0, week 12
Change from baseline in hypoglycemic symptom score
Time Frame: week 0, week 12
week 0, week 12

Other Outcome Measures

Outcome Measure
Time Frame
Frequency of Hypoglycemic episodes
Time Frame: Week 0, week 12
Week 0, week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Collaborators

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

Investigators

  • Principal Investigator: Christian SS Frandsen, MD, Hvidovre University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimate)

March 20, 2014

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-002526-67 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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