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NCT01414556 Clinical Trial

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
Secondary ID
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

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
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