Status:
COMPLETED
Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)
Lead Sponsor:
Aarhus University Hospital
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
35-75 years
Phase:
PHASE2
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 subcutaneo...
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01510093
Start Date
May 1 2012
End Date
January 1 2013
Last Update
January 29 2013
Active Locations (1)
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1
Department of Endocrinology and Internal Diseases
Aarhus C, Central Jutland, Denmark, 8000