Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes

Phase 3CompletedNCT01520818

Novo Nordisk A/S666 enrolled

Overview

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

666

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 50DRUG

Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being obese with a body mass index (BMI) exceeding 30 kg/m\^2 will receive BIAsp 50

biphasic insulin aspart 70DRUG

Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being lean and overweight with a body mass index (BMI) of maximum 30 kg/m\^2 will receive BIAsp 70

biphasic human insulin 30DRUG

Administered subcutaneously (s.c., under the skin), twice a day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 or Type 2 diabetes * Current treatment with BHI 30 twice daily as the only insulin therapy for at least 3 months, with or without combination with oral hypoglycaemic agents * Body mass index (BMI) maximum 40.0 kg/m\^2 Exclusion Criteria: * History of drug or alcohol dependence * Impaired hepatic function * Impaired renal function * Cardiac disease * Proliferative retinopathy * Total daily insulin dose at least 1.80 IU/kg

Locations (77)

Outcomes

Primary Outcomes

HbA1c (glycosylated haemoglobin A1c)

Secondary Outcomes

Blood glucose profiles

Adverse events

Hypoglycaemic episodes

Quality of Life (QoL) assessed via World Health Organization Diabetes Treatment Satisfaction Questionnaire (WHO DTSQ)

Quality of Life (QoL) assessed via Diabetes Health Profile (DHP-2)

Data from ClinicalTrials.gov

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