Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)

Overview

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

Full Title of Study: “Interactions Between Exogenous Insulin Aspart, Endogenous Insulin and Plasma Glucose in Type 2 Diabetes Mellitus Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2012

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.

Interventions

  • Drug: Insulin Aspart 100 IE/ml
    • 1.5 IE/hour/subject/visit. Each vist takes 10 hours

Arms, Groups and Cohorts

  • Other: Insulin Aspart without glucose supply
    • Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight without intravenous glucose supply
  • Other: Insulin Aspart with glucose supply
    • Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight combined with intravenous glucose supply

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetic profiles of endogenous insulin and Insulin Aspart
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aarhus University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jurgita Janukonyte, Medical doctor – Aarhus University Hospital
  • Overall Official(s)
    • Jurgita Janukonyte, MD, Principal Investigator, University of Aarhus

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