Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes

Phase 3CompletedNCT01520753

Novo Nordisk A/S16 enrolled

Overview

This trial is conducted in Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 70DRUG

Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner

biphasic insulin aspart 70DRUG

Administered subcutaneously (s.c., under the skin) at breakfast and lunch

biphasic insulin aspart 50DRUG

Administered subcutaneously (s.c., under the skin) at dinner

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes * Duration of diabetes for longer than 12 months * Body mass index (BMI) below 35.0 kg/m\^2 * HbA1c below 11.0 % * Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement) Exclusion Criteria: * Current treatment with agents affecting glucose metabolism * History of drug or alcohol dependence * Impaired hepatic function * Impaired renal function * Cardiac disease * Proliferative retinopathy * Recurrent severe hypoglycaemia or advanced neuropathy

Locations (1)

Novo Nordisk Investigational Site

Århus C, Denmark

Outcomes

Primary Outcomes

Fasting serum glucose

Secondary Outcomes

24-hour serum glucose profiles

24-hour insulin profiles

Incidence of hypoglycaemic episodes

Incidence of adverse events

Data from ClinicalTrials.gov

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