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NCT01492153 Clinical Trial

NovoLet® Surveillance Study on Using Human Insulin System in Indonesia

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Post Marketing Surveillance on the Use of NovoLet® Human Insulin System in Indonesia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01492153
Other study ID # NOPEN3-1886
Secondary ID
Status Completed
Phase N/A
First received December 12, 2011
Last updated February 24, 2017
Start date February 11, 2003
Est. completion date September 5, 2006

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 1981
Est. completion date September 5, 2006
Est. primary completion date September 5, 2006
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Type 1 diabetes mellitus

- Type 2 diabetes mellitus

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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic human insulin
NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator
• isophane human insulin
NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator
• human soluble insulin
NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator

Locations
Country Name City State
Indonesia Novo Nordisk Investigational Site Jakarta

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in body weight
Secondary Fasting blood glucose (FBG)
Secondary 2 hours postprandial blood glucose (2-hr PPBG)
Secondary HbA1c (glycosylated haemoglobin)
Secondary Adverse events (AEs) including hypoglycaemic episodes
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