Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jurgita Janukonyte, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01510093
First received: January 11, 2012
Last updated: January 28, 2013
Last verified: January 2013

January 11, 2012
January 28, 2013
May 2012
December 2012   (final data collection date for primary outcome measure)
Pharmacokinetic profiles of endogenous insulin and Insulin Aspart [ Time Frame: 10 hours ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01510093 on ClinicalTrials.gov Archive Site
Pharmacodynamic glucose profiles [ Time Frame: 10 hours ] [ Designated as safety issue: Yes ]
Pharmacodynamic glucose profiles after treatment with Insulin Aspart administred by insulin pump as a continuous subcutaneous infusion .
Same as current
Not Provided
Not Provided
 
Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)
Interactions Between Exogenous Insulin Aspart, Endogenous Insulin and Plasma Glucose in Type 2 Diabetes Mellitus Patients

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: Insulin Aspart 100 IE/ml
1.5 IE/hour/subject/visit. Each vist takes 10 hours
Other Name: NovoRapid 100 IE/ml
  • Insulin Aspart without glucose supply
    Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight without intravenous glucose supply
    Intervention: Drug: Insulin Aspart 100 IE/ml
  • Insulin Aspart with glucose supply
    Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight combined with intravenous glucose supply
    Intervention: Drug: Insulin Aspart 100 IE/ml
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
January 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01510093
2011/1811
Yes
Jurgita Janukonyte, Aarhus University Hospital
Aarhus University Hospital
Not Provided
Principal Investigator: Jurgita Janukonyte, MD University of Aarhus
Aarhus University Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP