Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Insulin Aspart 100 IE/ml

• Registration Number: NCT01510093
• Lead Sponsor: Aarhus University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-13
• Study Start: 2012-05
• Primary Completion: 2012-12
• Status Verified: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Subjects with type 2 diabetes mellitus
• Insulin-naive patients
• HbA1C < 9%
• Women and men >= 35 and <= 75 years old
• BMI 25-42 kg/m2, both values are included

Exclusion Criteria

• Suspected or known allergy to the trial drug or similar medications
• Treatment with hte drugs that after Investigator judgment could potentially interfere with plasma glucose levels
• Heart: Unstable angina pectoris, acute myocardial infarction within the last 12 months
• Severe uncontrolled hypertension with blood pressure in lying position > 180/110 mmHg
• Impaired liver function with liver parameters more than 2 times above the upper normal limit according to the local laboratory
• Impaired kidney function with eGFR < 50 ml/min according to the local laboratory
• Pregnancy, lactation or desire for pregnancy in the study period and for women in childbearing age without adequate contraception-adequate contraception is: sterilisation, hysterectomy or current use of contraceptive pills, coil, gestagen depot injection, subdermal implantation, hormonal vaginal ring and transdermal depot patch.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin Aspart without glucose supply	Insulin Aspart 100 IE/ml	Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight without intravenous glucose supply
Insulin Aspart with glucose supply	Insulin Aspart 100 IE/ml	Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight combined with intravenous glucose supply

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic profiles of endogenous insulin and Insulin Aspart	10 hours	Pharmacokinetic profiles of endogenous insulin and Insulin Aspart in type 2 diabetes melitus patients treated with continuous subcutaneous Insulin Aspart infusion by insulin pump and combined with or without intravenous supply of glucose

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic glucose profiles	10 hours	Pharmacodynamic glucose profiles after treatment with Insulin Aspart administred by insulin pump as a continuous subcutaneous infusion .

Trial Locations

Locations (1)

Department of Endocrinology and Internal Diseases; 🇩🇰 Aarhus C, Central Denmark Region, Denmark