Interactions between synthetic insulin, body insulin and blood sugar in diabetes patients

Interactions between exogenous Insulin Aspart, endogenous insulin and plasma glucose in type 2 diabetes mellitus patients - Endogenous insulin Jurgita II-2011/1811

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005702-30-DK

Enrollment

Unknown

Registered

2011-12-12

Start date

2011-12-22

Completion date

Unknown

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus MedDRA version: 14.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: NovoRapid 100 IE/ml Pharmaceutical Form: Infusion INN or Proposed INN: INSULIN ASPART CAS Number: 116094-23-6 Other descriptive name: NovoRapid Concentration unit: IU international unit(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Signed and dated informed consent • Type 2 diabetes according to the WHO classification for at least 6 months • Insulin-naive patients who have never been treated with insulin • HbA1c =65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: • Suspected or known allergy to the trial drug or similar medications • Treatment with the drugs that after investigator judgment could potentially interfere with plasma glucose levels • Heart: Unstable angina pectoris, AMI 180/110 mmHg (in lying position) • Liver: Impaired liver function with plasma ALAT or alkaline phosphatase levels > 2 times the upper normal limit according to the local laboratory • Kidneys: eGFR< 50 ml/min/l 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the pharmacokinetic profiles of endogenous insulin and exogenous Insulin Aspart (IAsp) in type 2 diabetes patients treated with continuous subcutaneous (sc) IAsp infusion via insulin pump with or without intravenous (iv) glucose infusion;Secondary Objective: To evaluate the pharmacodynamic (PD) glucose profiles after treatment with continuous sc IAsp infusion via insulin pump with or without iv glucose infusion.;Primary end point(s): • PK profiles of patient serum endogenous insulin concentration curves under treatment regiment A (without iv glucose infusion) and B (with iv glucose infusion);Timepoint(s) of evaluation of this end point: AUC 22-08h	—

Measure

Time frame

Main Objective: To evaluate the pharmacokinetic profiles of endogenous insulin and exogenous Insulin Aspart (IAsp) in type 2 diabetes patients treated with continuous subcutaneous (sc) IAsp infusion via insulin pump with or without intravenous (iv) glucose infusion;Secondary Objective: To evaluate the pharmacodynamic (PD) glucose profiles after treatment with continuous sc IAsp infusion via insulin pump with or without iv glucose infusion.;Primary end point(s): • PK profiles of patient serum endogenous insulin concentration curves under treatment regiment A (without iv glucose infusion) and B (with iv glucose infusion);Timepoint(s) of evaluation of this end point: AUC 22-08h

—

Secondary

Measure	Time frame
Secondary end point(s): • PK profiles of patient serum IAsp concentration curves under treatment regiment A and B • PD profiles of inividual plasma glucose concentration curves under treatment regiment A and B;Timepoint(s) of evaluation of this end point: AUC 22-08h	—

Countries

Denmark

Contacts

Public ContactAarhus University

Aarhus University

au@au.dk+458942 1111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026