Effect of GLP-1 and GIP on Insulin Secretion in Type-1 Diabetes Mellitus

Type-1 Diabetes Mellitus Clinical Trial

Official title:

Effect of GLP-1 and GIP on the Maximal Insulin Secretory Capacity in Type-1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603031
• Other study ID #: H-D-2007-0076
• Secondary ID: 2008-000305-11
• Status: Completed
• Phase: N/A
• First received: January 15, 2008
• Last updated: January 20, 2011
• Start date: January 2008
• Est. completion date: June 2008

Study information

• Verified date: August 2009
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

study hypothesis: treatment with GLP-1 and/or GIP is able to potentiate the maximal stimulated insulin secretion even in c-peptide negative type-1 diabetic patients classified as having no residual beta cell function left.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 18-60 years

• Type-1 diabetes diagnosed between 5-40 years of age

• Normal weight(BMI 18-27),

• Insulin treatment from time of diagnosis.

Exclusion Criteria:

• Severe complications to diabetes

• Abnormal liver or kidney function

• Haemoglobin below the lower limit

• Macroalbuminuria

• Systemic disease

• Pregnancy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type-1 Diabetes Mellitus

Intervention

Other:
• glucagon like peptide -1
continuous infusion 1,2 pmol pr. kg pr minute at 120 minutes
• NaCl
infusion with NaCl for 120 minutes as placebo-arm
• glucose dependent insulinotropic polypeptide
continuous infusion with GIP-1 (3,6pmol/kg/min) at 120 minutes.

Locations

Country	Name	City	State
Denmark	Dept. of Endocrinology, Hvidovre Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	phase insulin response and phase insulin response measured as incremental area under the curve from 0-10 minutes and incremental area under the curve from 10-45 minutes respectively after iv glucose		2 hours	No
Secondary	maximal insulin response defined as mean insulin at time 47 and 49 minutes (2 and 4 minutes after infusion of L-Arginine)		2 hours	No