Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 in Type 2 Diabetes

Novo Nordisk A/S170 enrolled

Overview

This trial is conducted in Europe. The aim of this trial is to investigate the difference in frequency of episodes of hypoglycaemia during treatment with biphasic insulin aspart 30 compared to biphasic human insulin 30 in subjects with well controlled type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

170

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic human insulin 30DRUG

Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2

biphasic insulin aspart 30DRUG

Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes * Treated with insulin 1-3 injections daily for at least 6 months * Body Mass Index (BMI) below 40 kg/m\^2 * HbA1c (glycosylated haemoglobin A1c) below 9.5% at screening Exclusion Criteria: * Total insulin dosage more than 1.8 IU/kg * Impaired hepatic or renal function or significant cardiac problems

Locations (17)

Novo Nordisk Investigational Site

Bolton, United Kingdom

Novo Nordisk Investigational Site

Cardiff, United Kingdom

Outcomes

Primary Outcomes

Frequency of hypoglycaemic episodes

Secondary Outcomes

Frequency of reported severe hypoglycaemic episodes

Overall frequency of nocturnal hypoglycaemia

HbA1c (glycosylated haemoglobin A1c)

Diabetes Treatment Satisfaction Questionaire

Data from ClinicalTrials.gov

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