A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70. - A Randomised, Quadruple Cross-Over Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Primary endpoint:
Study Overview
Brief Summary
The hypothesis is that an optimal formulation of fast acting and intermediary acting insulin analogues will improve post prandial glycaemic control in patients with type 1 diabetes.
OBJECTIVE:
The objective is to describe pharmacodynamic (PD) and pharmacokinetic (PK) profiles of Insulin Aspart (IAsp), Biphasic Insulin Aspart (BIAsp) 30, 50 and 70 for a period of 12 hours following a standard test meal on four days respectively in subjects with type 1 diabetes.
Detailed Description
This trial is a single centre, open-label, randomised 4 period cross-over trial, comparing the pk and pd profiles of IAsp, BIAsp 30, BIAsp 50 and BIAsp 70 after a standard test meal in subjects with type 1 diabetes. The profiles will be derived over a 12-hour period after subcutaneous injection in the abdominal region with a single dose of IAsp, BIAsp 30, BIAsp 50 or BIAsp 70 at a test meal. The trial consists of a screening period of 4-21 days and 4 treatment visits
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Informed consent obtained before any trial-related activities.
- •Diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis.
- •Insulin treatment of any regime for more than one year at time of inclusion.
- •Total insulin demand ≥ 0,5 IU/kg/24 hrs
- •HbA1c between 7% and 12 % (both values included).
- •Age ≥ 18 years.
- •BMI between 18 and 35 kg /m2 (including both values).
Exclusion Criteria
- •Known or suspected allergy to trial product(s) or related products.
- •Recurrent major hypoglycaemic episodes.
- •Heart: Unstable Angina Pectoris, AMI < 12 months or heart insufficiency classified according to NYHA III-IV
- •Blood Pressure: Severe uncontrolled hypertension with BP > 180/110 mmHg, sitting
- •Liver: Impaired hepatic function corresponding to serum-ALAT or -basic phosphatase > 2x upper reference limit of the local laboratory.
- •Kidneys: Impaired renal function corresponding to serum-creatinin > 150 μmol/l according to the local laboratory.
- •Any disease judged by the investigator to affect the trial.
- •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.
- •The receipt of any investigational drug within a three month period prior to this trial.
Outcomes
Primary Outcomes
Primary endpoint:
• Cmaxglu: Peak plasma glucose following test meal (breakfast). A comparison will be made between BIAsp 50 vs BIAsp 70, BIAsp 30 vs BIAsp 70, BIAsp 30 vs BIAsp 50 and IAsp vs BIAsp 30, 50 and 70.
Secondary Outcomes
- Secondary endpoints:
- AUCglu: The area under the plasma glucose concentration (0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after test meal) after a single injection of one of the four insulin aspart preparation: IAsp (NovoRapid®), Biphasic insulin aspart 30, 50 and 70.
- AUCins: The area under insulin aspart concentration (0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after test meal) after a single injection of one of the four insulin aspart preparation: IAsp (NovoRapid®), Biphasic insulin aspart 30, 50 and 70.