NCT01510093

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:

  1. 1.Secretion of endogenous insulin depends on exogenous insulin supply
  2. 2.Secretion of endogenous insulin is depends on plasma glucose levels

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started May 2012

Shorter than P25 for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

7 months

First QC Date

January 11, 2012

Last Update Submit

January 28, 2013

Conditions

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes mellitus, endogenous insulin

Outcome Measures

Primary Outcomes (1)

  • 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

    10 hours

Secondary Outcomes (1)

  • Pharmacodynamic glucose profiles

    10 hours

Study Arms (2)

Insulin Aspart without glucose supply

OTHER

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

Drug: Insulin Aspart 100 IE/ml

Insulin Aspart with glucose supply

OTHER

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

Interventions

Insulin Aspart 100 IE/mlDRUG

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

Also known as: NovoRapid 100 IE/ml
Insulin Aspart with glucose supplyInsulin Aspart without glucose supply

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology and Internal Diseases

Aarhus C, Central Jutland, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 25785658DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jurgita Janukonyte, MD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

January 11, 2012

First Posted

January 13, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

DK(1)