Liraglutide as add-on to Insulin in Type 1 Diabetes

Diabetes Clinical Trial

— T1DMLIRA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092896
• Other study ID #: 2012-002526-67
• Secondary ID: 2012-002526-67
• Status: Completed
• Phase: Phase 3
• First received: March 18, 2014
• Last updated: March 31, 2015
• Start date: March 2013
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age: 18-70 years

• BMI: 18-28

• HbA1c = 8 %

• No residual ß-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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.
• 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.
• 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
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.

Locations

Country	Name	City	State
Denmark	Dept. of Endocrinology, Hvidovre University Hospital	Hvidovre	Copenhagen

Sponsors (5)

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

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of Hypoglycemic episodes		Week 0, week 12	Yes
Primary	Change from baseline in HbA1c (glycosylated haemoglobin)		Week 0, week 12	No
Primary	Changes from baseline in EEG and cognitive performances		week 0, week 12	No
Primary	Change from baseline in gastric emptying rate		week 0, week 12	No
Secondary	Change from baseline in glycemic control (CGM)		week 0, week 12	No
Secondary	Change from baseline in total daily insulin dose		week 0, week 12	No
Secondary	Changes from baseline in the counterregulatory hormone responses during hypoglycemia		week 0, week 12	No
Secondary	Change from baseline in body weight		week 0, week 12	No
Secondary	Change from baseline in auditory evoked potentials (AEP) during hypoglycemia		week 0, week 12	No
Secondary	Change from baseline in corrected QTc-interval (QTc) during hypoglycemia		week 0, week 12	No
Secondary	Change from baseline in hypoglycemic symptom score		week 0, week 12	No