Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)

Study Overview
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Brief Summary
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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: Secretion of endogenous insulin depends on exogenous insulin supply Secretion of endogenous insulin is depends on plasma glucose levels

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin Aspart 100 IE/ml


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Insulin Aspart without glucose supply<br>Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight without intravenous glucose supply | Drug: Insulin Aspart 100 IE/ml<br>* 1.5 IE/hour/subject/visit. Each vist takes 10 hours<br>* Other names: NovoRapid 100 IE/ml;|
| Other: Insulin Aspart with glucose supply<br>Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight combined with intravenous glucose supply | Drug: Insulin Aspart 100 IE/ml<br>* 1.5 IE/hour/subject/visit. Each vist takes 10 hours<br>* Other names: NovoRapid 100 IE/ml;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profiles of endogenous insulin and Insulin Aspart | 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 | 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic glucose profiles | Pharmacodynamic glucose profiles after treatment with Insulin Aspart administred by insulin pump as a continuous subcutaneous infusion . | 10 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes mellitus, endogenous insulin