NovoLet® Surveillance Study on Using Human Insulin System in Indonesia

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic human insulin; Drug: isophane human insulin; Drug: human soluble insulin

• Registration Number: NCT01492153
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02-11
• Primary Completion: 2006-09-05
• Study Completion: 2006-09-05
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-14
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-24
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1981

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NovoLet® device	isophane human insulin	-
NovoLet® device	biphasic human insulin	-
NovoLet® device	human soluble insulin	-

Primary Outcome Measures

Name	Time	Method
Change in body weight

Secondary Outcome Measures

Name	Time	Method
Fasting blood glucose (FBG)
2 hours postprandial blood glucose (2-hr PPBG)
HbA1c (glycosylated haemoglobin)
Adverse events (AEs) including hypoglycaemic episodes

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇮🇩 Jakarta, Indonesia