Comparison of Two Insulin Aspart Formulations in Healthy Volunteers

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT01698697

NN248-1494

Details and patient eligibility

About

This trial is conducted in Africa. The aim of this trial is to determine if a new formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin aspart formulation (U100).

Enrollment: 24 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
• Normal laboratory values, electrocardiogram (ECG), and vital signs unless the investigator considers any abnormality to be clinically irrelevant
• Body mass index (BMI) 18-26 kg/m^2 (both inclusive)
• Weight 60-90 kg
• Non-smoker

Exclusion criteria

• Any condition requiring the regular use of any medication
• Known or suspected allergy to the trial product or related products
• Family history of type 1 diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups

U100

Active Comparator group

Treatment:

Drug: insulin aspart

U200

Experimental group

Treatment:

Drug: insulin aspart