Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)
NCT ID: NCT01510093
Last Updated: 2013-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2012-05-31
2013-01-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Insulin Aspart without glucose supply
Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight without intravenous glucose supply
Insulin Aspart 100 IE/ml
1.5 IE/hour/subject/visit. Each vist takes 10 hours
Insulin Aspart with glucose supply
Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight combined with intravenous glucose supply
Insulin Aspart 100 IE/ml
1.5 IE/hour/subject/visit. Each vist takes 10 hours
Interventions
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Insulin Aspart 100 IE/ml
1.5 IE/hour/subject/visit. Each vist takes 10 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Insulin-naive patients
* HbA1C \< 9%
* Women and men \>= 35 and \<= 75 years old
* BMI 25-42 kg/m2, both values are included
Exclusion Criteria
* 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.
35 Years
75 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Responsible Party
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Jurgita Janukonyte
Medical doctor
Principal Investigators
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Jurgita Janukonyte, MD
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Locations
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Department of Endocrinology and Internal Diseases
Aarhus C, Central Jutland, Denmark
Countries
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References
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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.
Other Identifiers
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2011/1811
Identifier Type: -
Identifier Source: org_study_id
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