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Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Insulin Aspart 100 IE/ml
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring type 2 diabetes mellitus, endogenous insulin

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Endocrinology and Internal Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Insulin Aspart without glucose supply

Insulin Aspart with glucose supply

Arm Description

Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight without intravenous glucose supply

Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight combined with intravenous glucose supply

Outcomes

Primary Outcome Measures

Pharmacokinetic profiles of endogenous insulin and Insulin Aspart
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
Pharmacodynamic glucose profiles after treatment with Insulin Aspart administred by insulin pump as a continuous subcutaneous infusion .

Full Information

First Posted
January 11, 2012
Last Updated
January 28, 2013
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01510093
Brief Title
Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)
Official Title
Interactions Between Exogenous Insulin Aspart, Endogenous Insulin and Plasma Glucose in Type 2 Diabetes Mellitus Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 subcutaneous Insulin Aspart infusion and combined with or without intravenous glucose infusion. The order of treatment session will be randomised. Hypotheses: Secretion of endogenous insulin depends on exogenous insulin supply Secretion of endogenous insulin is depends on plasma glucose levels
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
type 2 diabetes mellitus, endogenous insulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin Aspart without glucose supply
Arm Type
Other
Arm Description
Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight without intravenous glucose supply
Arm Title
Insulin Aspart with glucose supply
Arm Type
Other
Arm Description
Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight combined with intravenous glucose supply
Intervention Type
Drug
Intervention Name(s)
Insulin Aspart 100 IE/ml
Other Intervention Name(s)
NovoRapid 100 IE/ml
Intervention Description
1.5 IE/hour/subject/visit. Each vist takes 10 hours
Primary Outcome Measure Information:
Title
Pharmacokinetic profiles of endogenous insulin and Insulin Aspart
Description
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
Time Frame
10 hours
Secondary Outcome Measure Information:
Title
Pharmacodynamic glucose profiles
Description
Pharmacodynamic glucose profiles after treatment with Insulin Aspart administred by insulin pump as a continuous subcutaneous infusion .
Time Frame
10 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jurgita Janukonyte, MD
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology and Internal Diseases
City
Aarhus C
State/Province
Central Denmark Region
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25785658
Citation
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.
Results Reference
derived

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Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)

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