Observational Study With InnoLet® in Daily Clinical Practice

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01492959
First received: December 9, 2011
Last updated: April 11, 2012
Last verified: April 2012
  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) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events: Serious and non-serious [ Designated as safety issue: No ]

Enrollment: 1030
Study Start Date: March 2004
Study Completion Date: March 2005
Primary Completion Date: March 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

Genders Eligible for Study:   Both
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
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: NCT01492959

Locations
Korea, Republic of
Seoul, Korea, Republic of, 137-920
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Corporate Vice President for diabetes and devices Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01492959     History of Changes
Other Study ID Numbers: INNOLET-1888
Study First Received: December 9, 2011
Last Updated: April 11, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014