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Completed

NCT Number: NCT01510093

Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)

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

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Endocrinology and Internal Diseases

Aarhus C, Central Jutland, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin Aspart 100 IE/ml

Drug

1.5 IE/hour/subject/visit. Each vist takes 10 hours

Other names: NovoRapid 100 IE/ml

Primary outcomes

  1. 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 outcomes

  1. Pharmacodynamic glucose profiles

    Time frame: 10 hours

    Pharmacodynamic glucose profiles after treatment with Insulin Aspart administred by insulin pump as a continuous subcutaneous infusion .

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jan 13, 2012
Registry last updated
Jan 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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