Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes

Novo Nordisk A/S220 enrolled

Overview

This trial is conducted in Asia. The aim of this trial is to compare the efficacy of postprandial plasma glucose of two treatment regimens in Chinese subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

220

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

soluble human insulinDRUG

insulin aspartDRUG

insulin NPHDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 or 2 diabetes for at least 4 weeks * Treatment with oral antidiabetic drugs (OADs) and/or insulin for at least 4 weeks * HbA1c: 7.5-13.5% * Body Mass Index (BMI): 18-35 kg/m2 Exclusion Criteria: * Treatment with either soluble human insulin or insulin NPH three times daily within 3 months before trial participation * History of drug abuse or alcohol dependence

Locations (5)

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Novo Nordisk Investigational Site

Harbin, Heilongjiang, China

Outcomes

Primary Outcomes

2-hours postprandial plasma glucose (PPPG)

Time frame: after 12 weeks of treatment

Secondary Outcomes

Percentage of subjects achieving 2-hours PPPG treatment target

Percentage of subjects achieving HbA1c treatment target

HbA1c

Fasting plasma glucose

Hypoglycaemic episodes

Data from ClinicalTrials.gov

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