GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

— GIP-HYPO-T2DM  

Official title:

Effects of Glucose-dependent Insulinotropic Polypeptide at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414556
• Other study ID #: H-2-2009-078
• Status: Completed
• Phase: Phase 0
• First received: August 5, 2011
• Last updated: March 31, 2013
• Start date: May 2011
• Est. completion date: November 2012

Study information

• Verified date: March 2013
• 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 GIP effects at fasting and hypoglycemia

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Caucasians 18 years or older with Type 2 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 og IV)

• Anemia

• treatment with medication not applicable to pause for 12 hours

• Fasting plasma glucose >15 mM on screening day.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypoglycemia
• Type 2 Diabetes Mellitus

Intervention

Other:
• Glucose-dependent Insulinotropic polypeptide
infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min
• saline

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Mikkel Christensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucagon/insulin(c-peptide) absolute, incremental and area under curve values		approx. 15 minutes intervals, time 0 to 120 min	No
Secondary	plasma gut hormones and nutrients		approx. 15 minutes intervals, time 0 to 120 min	No