Observational Study of Type 2 Diabetes Patients Failing on Oral Anti-diabetic Agents Initiated on Levemir® or Insulatard®

Change in Weight on Insulin Detemir (Levemir®) or Isophane (NPH) Insulin (Insulatard®) in Patients With Type 2 Diabetes Mellitus

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00658099

Acronym

EVIDENCE

Enrollment

699

Registered

2008-04-14

Start date

2007-11-30

Completion date

2008-06-30

Last updated

2017-01-31

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 change in weight in type 2 diabetes patients using Levemir® or Insulatard® under normal clinical practice conditions.

Interventions

DRUGinsulin detemir

Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

DRUGinsulin NPH

Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Type 2 diabetes * HbA1c greater than 7.0% and/or hypoglycaemia * variable FBG and/or weight increase * the selection of the subjects will be at the discretion of the participating physician

Exclusion criteria

* non-type 2 diabetes * current treatment with Levemir® or Insulatard® * hypersensitivity to Levemir® or Insulatard® or to any of the excipients * women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months

Design outcomes

Primary

Measure	Time frame
Change in weight	after 6 months of treatment

Secondary

Measure	Time frame
The incidence of hypoglycaemic events	after 6 months of treatment
Safety parameters by collecting (serious) adverse drug reactions, pregnancies and technical complaints.	after 6 months of treatment
The effect on metabolic control assessed by the changes in glycaemic parameters: HbA1c and blood glucose values	after 6 months of treatment
The treatment satisfaction of subjects treated with insulin detemir or NPH insulin by using insulin treatment satisfaction questionnaire	after 6 months of treatment
The satisfaction of physicians who treat the subjects with either insulin detemir or NPH insulin by using 4 questions, which are included in CRF, at the final visit.	after 6 months of treatment
The general well-being by using the WHO-5 well-being questionnaire.	after 6 months of treatment

Countries

Romania

Outcome results

None listed

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