GIP and GLP-1 in Type 1 Diabetes

Hypoglycemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739283
• Other study ID #: H-2-2009-078 33269
• Status: Completed
• Phase: N/A
• First received: November 17, 2012
• Last updated: July 10, 2015
• Start date: July 2012
• Est. completion date: November 2013

Study information

• Verified date: July 2015
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and hypoglycemia in type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Diagnosed with type 1 diabetes (WHO criteria)

Exclusion Criteria:

• HbA1c > 9 %

• Liver disease (ALAT/ASAT > 2 x upper normal limit)

• Diabetic nephropathy (s-creatinine > 130 µM or albuminuria)

• Proliferative diabetic retinopathy (anamnestic)

• Severe arteriosclerosis or heart failure (NYHA group III or IV)

• Anemia

• treatment with medication not applicable to pause for 12 hours

• C-peptide increase after 50 g iv arginine

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypoglycemia

Intervention

Other:
• GIP

• GLP-1

• Saline

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
Mikkel Christensen	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glucose and glycerol tracer kinetics		approx. 15 minutes intervals, time 0 to 120 min	No
Other	glucose (g/kg body weight) needed to be infuse to keep clamp		approx. 15 minutes intervals, time 0 to 120 min	No
Primary	plasma glucagon area under curve values		approx. 15 minutes intervals, time 0 to 120 min	No
Secondary	plasma gut hormones and nutrients (absolute, incremental and area under curve values)		approx. 15 minutes intervals, time 0 to 120 min	No