Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aarhus University Hospital
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

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.