Liraglutide as add-on to Insulin in Type 1 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes
• Interventions: Drug: Placebo; Drug: Liraglutide

• Registration Number: NCT02092896
• Lead Sponsor: Hvidovre University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-20
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liraglutide + Insulin + Study 2	Placebo	Study 2: Cognitive performance test
Placebo + Insulin + Study 1	Placebo	Study 1: Gastric emptying test
Placebo + Insulin + Study 2	Liraglutide	Study 2: Cognitive performance test
Liraglutide + Insulin + Study 1	Liraglutide	Study 1: Gastric emptying test

Primary Outcome Measures

Name	Time	Method
Change from baseline in gastric emptying rate	week 0, week 12
Change from baseline in HbA1c (glycosylated haemoglobin)	Week 0, week 12
Changes from baseline in EEG and cognitive performances	week 0, week 12

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dept. of Endocrinology, Hvidovre University Hospital; 🇩🇰 Hvidovre, Copenhagen, Denmark