Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes

Novo Nordisk A/S292 enrolled

Overview

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

292

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspartDRUG

Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily

biphasic human insulinDRUG

Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes for at least 24 months * Insulin treatment for the pase 3 months * HbA1c (glycosylated haemoglobin) below 13% * BMI (Body Mass Index) below 40 kg/m\^2 * Ability and willingness to perform self-blood glucose monitoring Exclusion Criteria: * Receipt of any investigational drug within 4 weeks prior to this trial * Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial * Total daily insulin dosage less than or equal to 1.8 IU/kg

Locations (57)

Outcomes

Primary Outcomes

HbA1c (glycolated haemoglobin)

Secondary Outcomes

Prandial increment in blood glucose

7-point blood glucose profile

Number and severity of adverse events

Number and severity of local tolerability issues at the injection site

Number and severity of hypoglycaemic episodes

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.