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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 11, 2012

Last Updated Date

January 28, 2013

Start Date ^ICMJE

May 2012

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01510093 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 .

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)

Official Title ^ICMJE

Interactions Between Exogenous Insulin Aspart, Endogenous Insulin and Plasma Glucose in Type 2 Diabetes Mellitus Patients

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Drug: Insulin Aspart 100 IE/ml

1.5 IE/hour/subject/visit. Each vist takes 10 hours

Other Name: NovoRapid 100 IE/ml

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2013

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

35 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01510093

Other Study ID Numbers ^ICMJE

2011/1811

Has Data Monitoring Committee

Yes

Responsible Party

Jurgita Janukonyte, Aarhus University Hospital

Study Sponsor ^ICMJE

Aarhus University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jurgita Janukonyte, MD

University of Aarhus

Information Provided By

Aarhus University Hospital

Verification Date

January 2013

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

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