Clinical trial NCT01510093: Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)
Official title: Interactions Between Exogenous Insulin Aspart, Endogenous Insulin and Plasma Glucose in Type 2 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: type 2 diabetes mellitus, endogenous insulin
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2012-01-13
Enrollment: 10
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Pharmacokinetic profiles of endogenous insulin and Insulin Aspart
timeFrame: 10 hours
Secondary outcomes:
measure: Pharmacodynamic glucose profiles
timeFrame: 10 hours
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Endocrinology and Internal Diseases
state: Central Denmark Region
Study officials:
affiliation: University of Aarhus
name: Jurgita Janukonyte, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janukonyte J, Parkner T, Bruun NH, Lauritzen T, Christiansen JS, Laursen T. Interaction between exogenous insulin, endogenous insulin, and glucose in type 2 diabetes patients. Diabetes Technol Ther. 2015 May;17(5):335-42. doi: 10.1089/dia.2014.0326. Epub 2015 Mar 18.