Effect of GLP-1 on insulin dose, risk of hypoglycemia and gastric emptying in type 1 diabetes mellitus - GLP-1 in type 1 diabetes

Phase 1

• Conditions: Type 1 diabetes; MedDRA version: 12.0Level: LLTClassification code 10012608Term: Diabetes mellitus insulin-dependent

• Registration Number: EUCTR2009-011930-80-DK
• Lead Sponsor: Department of Endocrinology, Hvidovre Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-02
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Type 1 diabetes, age 18-55, BMI 18-27, no known disease complications
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Impaired kidney function, any other systemic disease anticipated to prevent the patient from completing the trial, haemoglobin below lower limit, Hba1c >= 8.5%, autonomous nerve dysfunction

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether treatment with GLP-1 affects insulin dose and 24-hours glucose profiles in patients with type 1 diabetes;Secondary Objective: To investigate whether treatment with GLP-1:<br>1) affects the risk of hypoglycemia,<br>2)affects the gastric emptying rate of hypoglycemia<br>3)results in weight changes<br>4)affects the glycemic control (HbA1c and fructosamin);Primary end point(s): Insulin dose (IE/day)