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
  Purpose

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

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Insulin Aspart 100 IE/ml
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interactions Between Exogenous Insulin Aspart, Endogenous Insulin and Plasma Glucose in Type 2 Diabetes Mellitus Patients

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 .


Enrollment: 10
Study Start Date: May 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Insulin Aspart without glucose supply
Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight without intravenous glucose supply
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 with glucose supply
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
1.5 IE/hour/subject/visit. Each vist takes 10 hours
Other Name: NovoRapid 100 IE/ml

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

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510093

Locations
Denmark
Department of Endocrinology and Internal Diseases
Aarhus C, Central Denmark Region, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
Investigators
Principal Investigator: Jurgita Janukonyte, MD University of Aarhus
  More Information

No publications provided

Responsible Party: Jurgita Janukonyte, Medical doctor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01510093     History of Changes
Other Study ID Numbers: 2011/1811
Study First Received: January 11, 2012
Last Updated: January 28, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Aarhus University Hospital:
type 2 diabetes mellitus, endogenous insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014