NCT01510093

Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)

Interactions Between Exogenous Insulin Aspart, Endogenous Insulin and Plasma Glucose in Type 2 Diabetes Mellitus Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory trial with two cross-over arms investigating pharmacokinetic profiles of endogenous and exogenous insulin in type 2 diabetes mellitus patients treated with continuous subcutaneous Insulin Aspart infusion and combined with or without intravenous glucose infusion. The order of treatment session will be randomised. Hypotheses: 1. Secretion of endogenous insulin depends on exogenous insulin supply 2. Secretion of endogenous insulin is depends on plasma glucose levels

Detailed description

There are a screening visit and two treatment sessions: Session A: Treatment with Insulin Aspart 1.5 IE/time overnight without intravenous glucose infusion Session B: Treatment with Insulin Aspart 1.5 IE/time overnight with intravenous glucose infusion.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Insulin Aspart 100 IE/ml	1.5 IE/hour/subject/visit. Each vist takes 10 hours

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2012-01-13
• Last updated: 2013-01-29

Locations

1 site across 1 country: Denmark