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

NCT00873639 | Completed

• 1 other identifier: INS-3721
• Study Type: observational
• Target: 417
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  at 24 weeks from baseline

Secondary Outcomes (7)

• Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5%

  at 12 weeks and 24 weeks of treatment

• Change in FPG (glucose variability)

  at 12 weeks and 24 weeks of treatment

• Change in PPG (postprandial control)

  at 12 weeks and 24 weeks of treatment

• Change in insulin dose and number of injections

  at 12 weeks and 24 weeks of treatment

• Change in body weight

  at 12 weeks and 24 weeks of treatment

Study Arms (1)

A

Drug: insulin aspart; Drug: insulin detemir

Interventions

insulin aspart DRUG

Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice

Also known as: NovoRapid®, ANA

A

insulin detemir DRUG

Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice

A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Bucharest, 010031, Romania

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin Aspart; Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 1, 2009
• Study Start: April 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

RO (1)