NovoLet® Surveillance Study on Using Human Insulin System in Indonesia

NCT01492153 | Completed

• 1 other identifier: NOPEN3-1886
• Study Type: observational
• Target: 1,981
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in body weight

Secondary Outcomes (4)

• Fasting blood glucose (FBG)

• 2 hours postprandial blood glucose (2-hr PPBG)

• HbA1c (glycosylated haemoglobin)

• Adverse events (AEs) including hypoglycaemic episodes

Study Arms (1)

NovoLet® device

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

Interventions

biphasic human insulin DRUG

NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator

NovoLet® device

isophane human insulin DRUG

NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator

NovoLet® device

human soluble insulin DRUG

NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator

NovoLet® device

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with type 1 or type 2 diabetes mellitus or other types of diabetes mellitus (gestational, drug induced or metabolic syndrome-related) who are prescribed NovoLet® human insulin in the course of their diabetes mellitus management can be enrolled in the study

You may qualify if:

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Jakarta, 12520, Indonesia

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

biphasic human insulin 30; Insulin, Isophane

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1457)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 14, 2011
• Study Start: February 11, 2003
• Primary Completion: September 5, 2006
• Study Completion: September 5, 2006
• Last Updated: February 28, 2017

Record last verified: 2017-02

Locations

ID (1)