Human Insulin NPH and Insulin Aspart in Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 1; Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00597233

ANA-1529

Details and patient eligibility

About

This trial is conducted in South America. This aim of this trial is to evaluate the comparative prandial blood glucose lowering profile in subjects with type 1 diabetes.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes for at least 12 months
• Treatment with insulin NPH
• Body Mass Index (BMI) below 30 kg/m2

Exclusion criteria

• Total daily insulin dose greater than 1.40 IU/kg
• Treatment with oral antidiabetic drugs (OADs)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)