Observational Study of Patients Using Levemir® or Insulatard® as Start Insulin for Treatment of Diabetes

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: insulin NPH; Drug: insulin detemir

• Registration Number: NCT00715351
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control, weight change and hypoglycaemic effects in patients with type 2 diabetes with Levemir® compared to Insulatard® under normal clinical practice conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2008-07-11
• Study First Submitted QC: 2008-07-11
• Study First Posted: 2008-07-15
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

• Type 2 diabetes failing on oral blood glucose lowering therapy, and requiring insulin therapy.

Exclusion Criteria

• Type 1 diabetes
• Previous use of insulin

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B	insulin NPH	-
A	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Body weight change	at 3 months and 6 months after baseline

Secondary Outcome Measures

Name	Time	Method
Hypoglycemic events	at 3 months and 6 months after baseline
Changes in glycaemic parameters	at 3 months and 6 months after baseline
Safety parameters by collecting (serious) adverse events and the pregnancies.	at 3 months and 6 months after baseline
Evaluation of general well-being by using the WHO-5 well-being questionnaire (Appendix I).	at 3 months and 6 months after baseline
Treatment satisfaction of subjects treated with insulin Levemir or NPH insulin by using insulin satisfaction ('Tevredenheid met insuline behandeling': Appendix II)	at 3 months and 6 months after baseline
Satisfaction of physicians who treat the subjects with insulin Levemir or NPH in-sulin by using a scale of 0-10 (Appendix III).	at 3 months and 6 months after baseline
Changes in doses	at 3 months and 6 months after baseline
HbA1c	at 3 months and 6 months after baseline
Changes in daily blood glucose values	at 3 months and 6 months after baseline

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇮 Ljubljana, Slovenia