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

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin aspart; Drug: soluble human insulin; Drug: insulin NPH

Study type: Interventional

Funder types: Industry

Identifiers

NCT00593255

ANA-1634

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)