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

Hvidovre University Hospital

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: Liraglutide; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02092896

2012-002526-67 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 4 patient groups, including a placebo group

Placebo + Insulin + Study 2

Placebo Comparator group

Description:

Study 2: Cognitive performance test

Treatment:

Drug: Liraglutide

Drug: Liraglutide

Liraglutide + Insulin + Study 2

Experimental group

Description:

Study 2: Cognitive performance test

Treatment:

Drug: Placebo

Drug: Placebo

Liraglutide + Insulin + Study 1

Experimental group

Description:

Study 1: Gastric emptying test

Treatment:

Drug: Liraglutide

Drug: Liraglutide

Placebo + Insulin + Study 1

Placebo Comparator group

Description:

Study 1: Gastric emptying test

Treatment:

Drug: Placebo

Drug: Placebo