NovoLet® Surveillance Study on Using Human Insulin System in Indonesia

Novo Nordisk

Status: Completed

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

Treatments: Drug: biphasic human insulin; Drug: isophane human insulin; Drug: human soluble insulin

Study type: Observational

Funder types: Industry

Identifiers

NCT01492153

NOPEN3-1886

Details and patient eligibility

About

This study is conducted in Asia. The aim of this study is to investigate the safety and efficacy of NovoLet® human insulin delivery system in an outpatient setting.

Enrollment: 1,981 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Type 1 diabetes mellitus
• Type 2 diabetes mellitus
• Other types of diabetes mellitus (gestational, drug induced [thiazide] or metabolic syndrome-related)

Trial design

1,981 participants in 1 patient group

NovoLet® device

Treatment:

Drug: human soluble insulin

Drug: isophane human insulin

Drug: biphasic human insulin