Bioequivalence of Two Mixtard® 30 Formulations in Healthy Subjects

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: biphasic human insulin 30

Study type: Interventional

Funder types: Industry

Identifiers

NCT01486888

2005-006050-24 (EudraCT Number)

EX1000-1735

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to to test for bioequivalence between two formulations of Mixtard® 30 in healthy subjects.

Enrollment: 45 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
• Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2, inclusive
• Non-smoker, defined as no nicotine consumption for at least one year
• Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)

Exclusion criteria

• Previous participation in this trial or other clinical trials within the last 3 months
• Body weight above 87.5 kg
• Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3
• History of alcohol or drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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45 participants in 2 patient groups

Formulation A

Experimental group

Treatment:

Drug: biphasic human insulin 30

Formulation B

Active Comparator group

Treatment:

Drug: biphasic human insulin 30