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Observational Study With InnoLet® in Daily Clinical Practice

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01492959
First Posted: December 15, 2011
Last Update Posted: February 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This study is conducted in Asia. The aim of this study is to review the efficacy and safety of insulin treatment with InnoLet® in daily clinical practice.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Open, Uncontrolled, Observational Study With Innolet in Daily Clinical Situations According to the Product Labelling, Without Any Study Specific Investigations

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures:
  • Adverse events: Serious and non-serious

Enrollment: 1030
Actual Study Start Date: March 23, 2004
Study Completion Date: March 23, 2005
Primary Completion Date: March 23, 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Insulin human Drug: insulin human
Insulin human delivered with the InnoLet® device was prescribed according to product labelling to subjects in need of insulin treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Korean patients with diabetes mellitus in need of insulin treatment
Criteria

Inclusion Criteria:

  • Diabetes mellitus (Type 1 or type 2)
  • Need insulin treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492959


Locations
Korea, Republic of
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 137-920
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01492959     History of Changes
Other Study ID Numbers: INNOLET-1888
First Submitted: December 9, 2011
First Posted: December 15, 2011
Last Update Posted: February 28, 2017
Last Verified: February 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
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs