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

NCT00810589 | Completed Phase 1 DMC

• 1 other identifier: ENM-HS-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes, Type I

Outcome Measures

Primary Outcomes (1)

• Duration of action, time from onset of action until end of action

  32 h

Secondary Outcomes (1)

• GIRmax, maximum glucose infusion AUCGIR,0-32h, AUCGIR,0-12h, AUCGIR,12-32h, tinf=0, Cmax,ins, tmax,ins, AUCins,0-24h AUCins,0-∞ AUCins,0-12h AUCins,12-24h

  0-32 h, 0-12 h, 0-24 h

Study Arms (2)

1

EXPERIMENTAL

Drug: Levemir

2

ACTIVE COMPARATOR

Drug: Humalog NPL Insulin

Interventions

Levemir DRUG

0,4 IE per kg bodyweight

Also known as: Insulin Detemir

1

Humalog NPL Insulin DRUG

0,4 IE per kg bodyweight

Also known as: Humalog NPL

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained before any trial-related activities.
• Diagnosed with type 1 diabetes and treated with insulin
• Male or female subject between 18 and 65 years of age
• Body mass index between 18.0 and 32.0 kg/m2
• HbA1c (glycosylated haemoglobin A1c) ≤ 11%
• Fasting C-peptide ≤ 0.05 nmol/L
• Treatment with intensified insulin therapy or continuous subcutaneous human insulin or insulin analogue infusion (CSII)\] for at least 3 months.

You may not qualify if:

• Known or suspected allergy to the trial products or related products,
• Previous participation (randomised) in this trial.
• The receipt of any investigational product within 3 months prior
• Clinically significant abnormal haematology or biochemistry screening tests
• 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.
• Clinically significant abnormal ECG at screening
• Subject who has donated blood in excess of 500 mL within the 9 weeks preceding screening.
• Significant history of alcoholism or drug/chemical abuse
• Smoker
• Subject with mental incapacity or language barriers
• Surgery or trauma with significant blood loss within the 9 weeks preceding screening.
• Subject with a history of or presence of cancer
• 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.
• Current systemic treatment with drugs that could interfere with glucose metabolism \[such as systemic corticoids and monoamine oxidase (MAO) inhibitors\] and/or pharmacokinetics.
• Subject who has proliferative retinopathy or maculopathy and/or severe neuropathy (in particular autonomic neuropathy)

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz

Graz, Graz, 8036, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Thomas R. Pieber, MD

  Medical University Graz, Internal Medicine, Endocrinology and Nuclear Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 18, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 18, 2008

Record last verified: 2008-12

Locations

AU (1)