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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Liraglutide
* Drug: Liraglutide
* Other: continuous insulin therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: type 1 DM with betacell function: Liraglutide<br> | Drug: Liraglutide<br>* after optimal treatment on insulin alone 10 patients with type 1 diabetes are treated for four weeks with Liraglutide : in the first week at 0.6 mg sc and after one week optitration to the recommended 1.2 mg sc pr day.<br>|
| Experimental: type 1 DM without betacell function: Liraglutide<br> | Drug: Liraglutide<br>* after optimal treatment with insulin alone, 10 type 1 diabetic patients are treated with Liraglutide at a dose of 0.6 mg sc. After one week the dose is optitreted to the recommended 1.2 mg sc pr. day.<br>|
| No Intervention: type 1 DM without betacell function: Insulin<br> | Other: continuous insulin therapy<br>* after optimal treatment with insulin, patients continue on insulin for four weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin-dose |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hours glucose profiles with and without treatment of Victoza |  | three days | 
| risk of hypoglycemia during physical activity with and without Victoza |  | one day | 
| gastric emptying rate during hypoglycemia with and without Victoza |  | one day | 
| weight change from baseline, change in fructosamine from baseline |  | four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patients with type 1 diabetes mellitus