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NovoLet® Surveillance Study on Using Human Insulin System in Indonesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01492153
First received: December 12, 2011
Last updated: February 24, 2017
Last verified: February 2017
  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:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in body weight

Secondary Outcome Measures:
  • Fasting blood glucose (FBG)
  • 2 hours postprandial blood glucose (2-hr PPBG)
  • HbA1c (glycosylated haemoglobin)
  • Adverse events (AEs) including hypoglycaemic episodes

Enrollment: 1981
Actual Study Start Date: February 11, 2003
Study Completion Date: September 5, 2006
Primary Completion Date: September 5, 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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492153

Locations
Indonesia
Novo Nordisk Investigational Site
Jakarta, Indonesia, 12520
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1457) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: 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: February 24, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2017