Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes

Novo Nordisk A/S303 enrolled

Overview

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

303

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspartDRUG

Injected subcutaneously (under the skin) twice daily

biphasic human insulinDRUG

Injected subcutaneously (under the skin) twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months * Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months * Body mass index (BMI) below or equal to 35.0 kg/m\^2 * HbA1c below or equal to 11.0% Exclusion Criteria: * Total daily insulin dose at least 1.4 IU/kg * Treatment with oral hypoglycaemic agents within the month prior to inclusion * Recurrent severe hypoglycaemia (as judged by the investigator) * Active proliferative retinopathy * Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl) * History of pancreatitis

Locations (37)

Outcomes

Primary Outcomes

HbA1c (glycosylated haemoglobin A1c)

Secondary Outcomes

8-point blood glucose profiles

Incidence of hypoglycaemic episodes

Occurrence of adverse events

Data from ClinicalTrials.gov

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