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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993720
• Other study ID #: 2009-001930-80
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 9, 2009
• Last updated: January 20, 2011
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: October 2009
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia

Intervention

Drug:
• Liraglutide
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.
• Liraglutide
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.

Other:
• continuous insulin therapy
after optimal treatment with insulin, patients continue on insulin for four weeks

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin-dose		4 weeks	Yes
Secondary	24-hours glucose profiles with and without treatment of Victoza		three days	Yes
Secondary	risk of hypoglycemia during physical activity with and without Victoza		one day	Yes
Secondary	gastric emptying rate during hypoglycemia with and without Victoza		one day	Yes
Secondary	weight change from baseline, change in fructosamine from baseline		four weeks	No