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 A/S
ClinicalTrials.gov Identifier:
NCT00873639
First received: March 31, 2009
Last updated: July 17, 2012
Last verified: July 2012
  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 ] [ 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
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: NCT00873639

Locations
Romania
Bucharest, Romania, 010031
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Emiliana Corina Mocan, MD Novo Nordisk Romania
  More Information

Additional Information:
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
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Insulin Aspart
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014