A Randomised, Single Centre, Double-Blind, Two-Period Crossover, Glucose Clamp Trial

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Clinical pharmacology trials investigating insulin detemir in subjects with type 1 diabetes have shown a prolonged and reproducible action profile of insulin detemir compared with NPH insulin and insulin glargine. Duration of action of insulin detemir has been reported to be up to 24 hours.9,10,11 It has, however, been proposed that the mean duration of action is underestimated in glucose clamps lasting only 24 hours. This is so because a duration of action longer than 24 hours in individual clamps will be set to 24 hours in the mean calculation, whereas a shorter duration of action in individual clamps will be set to the true value.

It has been shown in clinical pharmacology trials that NPL insulin has an action profile comparable to NPH insulin in subjects with type 1 diabetes. , However, a direct comparison of pharmacodynamic properties of insulin detemir and NPL insulin has not been performed to date.

To get further insight into the pharmacodynamic properties of insulin detemir compared with NPL insulin, this trial has been designed to compare pharmacodynamics in general and duration of action in particular between insulin detemir and NPL insulin in subjects with type 1 diabetes.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Treatments: Insulin; Insulin Detemir; Insulin Lispro; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. Informed consent obtained before any trial-related activities.

2. Diagnosed with type 1 diabetes and treated with insulin

3. Male or female subject between 18 and 65 years of age

4. Body mass index between 18.0 and 32.0 kg/m2

5. HbA1c (glycosylated haemoglobin A1c) ≤ 11%

6. Fasting C-peptide ≤ 0.05 nmol/L

7. Treatment with intensified insulin therapy or continuous subcutaneous human insulin or insulin analogue infusion (CSII)] for at least 3 months.

Exclusion criteria

1. Known or suspected allergy to the trial products or related products,

2. Previous participation (randomised) in this trial.

3. The receipt of any investigational product within 3 months prior

4. Clinically significant abnormal haematology or biochemistry screening tests

5. Subject who is known to have hepatitis or who is a carrier of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or has a positive result to the test for HIV antibodies.

6. Supine blood pressure at screening (after 5 min in the supine position) ≥ 180 mmHg for systolic and/or ≥ 100 mmHg for diastolic. This exclusion criterion also pertains to subjects being on antihypertensives.

7. Clinically significant abnormal ECG at screening

8. Subject who has donated blood in excess of 500 mL within the 9 weeks preceding screening.

9. Significant history of alcoholism or drug/chemical abuse

10. Smoker

11. Subject with mental incapacity or language barriers

12. Surgery or trauma with significant blood loss within the 9 weeks preceding screening.

13. Subject with a history of or presence of cancer

14. History of any illness or disease that, in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the trial product to the subject.

15. Current systemic treatment with drugs that could interfere with glucose metabolism [such as systemic corticoids and monoamine oxidase (MAO) inhibitors] and/or pharmacokinetics.

16. Subject who has proliferative retinopathy or maculopathy and/or severe neuropathy (in particular autonomic neuropathy)

17. Any condition that would interfere with trial participation or evaluation of results, as judged by the Investigator and/or the sponsor.

18. Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods