Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)

January 28, 2013 updated by: Jurgita Janukonyte, Aarhus University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Central Denmark Region
      • Aarhus C, Central Denmark Region, Denmark, 8000
        • Department of Endocrinology and Internal Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • NovoRapid 100 IE/ml
Other: 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 Names:
  • NovoRapid 100 IE/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic profiles of endogenous insulin and Insulin Aspart
Time Frame: 10 hours
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
10 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacodynamic glucose profiles
Time Frame: 10 hours
Pharmacodynamic glucose profiles after treatment with Insulin Aspart administred by insulin pump as a continuous subcutaneous infusion .
10 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Investigators

  • Principal Investigator: Jurgita Janukonyte, MD, University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

January 11, 2012

First Posted (Estimate)

January 13, 2012

Study Record Updates

Last Update Posted (Estimate)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/1811

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on Insulin Aspart 100 IE/ml

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe