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Observational Study of Type 1 Diabetics Switching From Human Insulins to Modern Insulin Analogues

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00873639
First Posted: April 1, 2009
Last Update Posted: October 14, 2016
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 trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoRapid® (insulin aspart) and Levemir® (insulin detemir) after switch from human insulins for treatment of type 1 diabetes under normal clinical practice conditions in Romania.

Condition Intervention
Diabetes Diabetes Mellitus, Type 1 Drug: insulin aspart Drug: insulin detemir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoRapid® (Insulin Aspart) and Levemir® (Insulin Detemir) in a Basal-bolus Regimen for Treatment of Type 1 Diabetes Mellitus in Romania

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: at 24 weeks from baseline ]

Secondary Outcome Measures:
  • Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5% [ Time Frame: at 12 weeks and 24 weeks of treatment ]
  • Change in FPG (glucose variability) [ Time Frame: at 12 weeks and 24 weeks of treatment ]
  • Change in PPG (postprandial control) [ Time Frame: at 12 weeks and 24 weeks of treatment ]
  • Change in insulin dose and number of injections [ Time Frame: at 12 weeks and 24 weeks of treatment ]
  • Change in body weight [ Time Frame: at 12 weeks and 24 weeks of treatment ]
  • Change in number of hypoglycaemic events [ Time Frame: at 12 weeks and 24 weeks of treatment ]
  • Number of adverse drug reactions (ADR) [ Time Frame: at 12 weeks and 24 weeks of treatment ]

Enrollment: 417
Study Start Date: April 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin aspart
Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice
Other Names:
  • NovoRapid®
  • ANA
Drug: insulin detemir
Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice

  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
Type 1 diabetes patients from diabetes centres who have been deemed appropriate to receive NovoRapid® and Levemir® as new treatment in basal-balus regimen and as part of routine care by the prescribing physician.
Criteria

Inclusion Criteria:

  • Any subject with type 1 diabetes who is treated with human rapid and intermediate (NPH) insulin in basal-bolus regimen

Exclusion Criteria:

  • Subjects currently being treated with insulin aspart and insulin detemir
  • Subjects who were previously enrolled in this study
  • Subjects with a hypersensitivity to insulin aspart or to any of the excipients
  • Subjects with a hypersensitivity to insulin detemir or to any of the excipients
  • Women who are pregnant or have the intention of becoming pregnant within next 6 months
  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): NCT00873639


Locations
Romania
Novo Nordisk Investigational Site
Bucharest, Romania, 010031
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: NCT00873639     History of Changes
Other Study ID Numbers: INS-3721
First Submitted: March 31, 2009
First Posted: April 1, 2009
Last Update Posted: October 14, 2016
Last Verified: October 2016

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