Safety and Efficacy of Insulin Aspart in Type 2 Diabetes

Novo Nordisk A/S123 enrolled

Overview

This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of NovoRapid® (insulin aspart) as meal time insulin in subjects with type 2 diabetes treated on a basal-bolus regimen with Neutral Protamine Hagedorn (NPH) human insulin.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

123

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin aspartDRUG

Administrated subcutaneously (s.c., under the skin) three times a day before each meal for 24 weeks

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes * Treated with insulin for at least 12 months and currently on a basal-bolus regimen for at least 12 weeks * HbA1c below or equal to 11.0% * BMI (body mass index) below 30 kg/m\^2

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

Incidence of hypoglycaemia

Secondary Outcomes

Incidence of adverse events (AEs)

Clinical laboratory tests: Haematology and biochemistry

Insulin antibodies

Glycaemic control parameters: Glycosylated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and post-prandial plasma glucose (PPPG)

Data from ClinicalTrials.gov

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