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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00873639
First received: March 31, 2009
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: at 24 weeks from baseline ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Change in FPG (glucose variability) [ Time Frame: at 12 weeks and 24 weeks of treatment ] [ Designated as safety issue: No ]
  • Change in PPG (postprandial control) [ Time Frame: at 12 weeks and 24 weeks of treatment ] [ Designated as safety issue: No ]
  • Change in insulin dose and number of injections [ Time Frame: at 12 weeks and 24 weeks of treatment ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: at 12 weeks and 24 weeks of treatment ] [ Designated as safety issue: No ]
  • Change in number of hypoglycaemic events [ Time Frame: at 12 weeks and 24 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Number of adverse drug reactions (ADR) [ Time Frame: at 12 weeks and 24 weeks of treatment ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   6 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00873639

Locations
Romania
Bucharest, Romania, 010031
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Emiliana Corina Mocan, MD Novo Nordisk Romania
  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: NCT00873639     History of Changes
Other Study ID Numbers: INS-3721
Study First Received: March 31, 2009
Last Updated: July 17, 2012
Health Authority: Romania: National Medicines Agency

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

ClinicalTrials.gov processed this record on May 19, 2013