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

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2011-005702-30-DK
• Lead Sponsor: Aarhus University Hospital, Department of Endocrinology and Internal Diseases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-12
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 < 9% according to the local laboratory
• Women and men = 35 og = 75 years old
• BMI between25 kg /m2 og 42 kg /m2, both values are included
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

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 < 12 months old or severe heart failure according to NYHA III-IV
• BP: Severe uncontrolled hypertension with BP > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): • PK profiles of patient serum IAsp concentration curves under treatment regiment A and B<br>• 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