A comparison of pharmacodynamics and pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 70 and 50 & Fast-acting Human Insulin in patients with Type 1 diabetes, A randomised, quadruple cross-over trial

Phase 1

• Conditions: Patients with type 1 diabetes; MedDRA version: 9.1Level: LLTClassification code 10012608Term: Diabetes mellitus insulin-dependent

• Registration Number: EUCTR2008-007176-22-DK
• Lead Sponsor: Department of Medicine M, Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-02-06
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Informed consent obtained before any trial-related activities.
2. Diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis.
3. Insulin treatment of any regime for more than one year at time of inclusion.
4. Total insulin demand = 0,4 U/IU/kg/24 hrs
5. HbA1c between 7% and 12% (both values included).
6. Age = 18 years.
7. BMI between 18 and 35 kg /m2 (including both values).

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known or suspected allergy to trial product(s) or related products.
2. Recurrent major hypoglycaemic episodes.
3. Heart: Unstable Angina Pectoris, AMI < 12 months or heart insufficiency classified according to NYHA III-IV
4. Blood Pressure: Severe uncontrolled hypertension with BP > 180/110 mmHg, sitting
5. Liver: Impaired hepatic function corresponding to serum-ALAT or basic phosphatase > 2 x upper reference limit of the local laboratory.
6. Kidneys: Impaired renal function corresponding to serum-creatinin > 150 µmol/l according to the local laboratory.
7. Any disease judged by the investigator to affect the trial.
8. Pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures – adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.

Study & Design

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