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

Efficacy and Safety of Glycaemic Control of Levemir® or Insulatard® in Patients With Type 2 Diabetes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00715351

Enrollment

342

Registered

2008-07-15

Start date

2007-05-31

Completion date

2008-07-31

Last updated

2016-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGinsulin detemir

Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician

DRUGinsulin NPH

Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Body weight change	at 3 months and 6 months after baseline

Secondary

Measure	Time frame
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
Hypoglycemic events	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
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

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026