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NovoLet® Surveillance Study on Using Human Insulin System in Indonesia

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01492153
First received: December 12, 2011
Last updated: April 11, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
 Drug: biphasic human insulin
Drug: isophane human insulin
Drug: human soluble insulin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post Marketing Surveillance on the Use of NovoLet® Human Insulin System in Indonesia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Change in body weight [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting blood glucose (FBG) [ Designated as safety issue: No ]
  • 2 hours postprandial blood glucose (2-hr PPBG) [ Designated as safety issue: No ]
  • HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
  • Adverse events (AEs) including hypoglycaemic episodes [ Designated as safety issue: No ]

Enrollment: 1981
Study Start Date: February 2003
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NovoLet® device 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
Drug: 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
Drug: 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus
  • Type 2 diabetes mellitus
  • Other types of diabetes mellitus (gestational, drug induced [thiazide] or metabolic syndrome-related)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492153

Locations
Indonesia
Jakarta, Indonesia, 12520
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Corporate Vice President for diabetes and devices Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01492153     History of Changes
Other Study ID Numbers: NOPEN3-1886
Study First Received: December 12, 2011
Last Updated: April 11, 2012
Health Authority: Indonesia: National Agency of Drug and Food Control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013