Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes

Hvidovre University Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetes Mellitus

Treatments: Drug: Liraglutide; Other: continuous insulin therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00993720

2009-001930-80

Details and patient eligibility

About

The aim of the study is to investigate the effect of Victoza (a GLP-1 receptor agonist)on insulin-dose, risk of hypoglycemia and gastric emptying rate during hypoglycemia in patients with type 1 diabetes.

Enrollment: 30 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18-50y,
• BMI 18-27,
• caucasian origin,
• type 1 diabetes diagnosed between age 5 and age 40,
• no known diabetes complications or cardiovascular diseases,
• no medication known to influence glucose homeostasis,
• no pregnancy

Exclusion criteria

• diabetes complications,
• autonomous nerve dysfunction,
• anaemia,
• HbA1c < 8.5% at screening,
• estimated by the investigator to be incapable of completing the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

type 1 DM with betacell function: Liraglutide

Experimental group

Treatment:

Drug: Liraglutide

Drug: Liraglutide

type 1 DM without betacell function: Liraglutide

Experimental group

Treatment:

Drug: Liraglutide

Drug: Liraglutide

type 1 DM without betacell function: Insulin

No Intervention group

Treatment:

Other: continuous insulin therapy