Skip to main content
OpenTrials
Completed

NCT Number: NCT00658099

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Bucharest, 010031, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

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

insulin NPH

Drug

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

Primary outcomes

  1. Change in weight

    Time frame: after 6 months of treatment

Secondary outcomes

  1. The effect on metabolic control assessed by the changes in glycaemic parameters: HbA1c and blood glucose values

    Time frame: after 6 months of treatment

  2. The incidence of hypoglycaemic events

    Time frame: after 6 months of treatment

  3. Safety parameters by collecting (serious) adverse drug reactions, pregnancies and technical complaints.

    Time frame: after 6 months of treatment

  4. The general well-being by using the WHO-5 well-being questionnaire.

    Time frame: after 6 months of treatment

  5. The treatment satisfaction of subjects treated with insulin detemir or NPH insulin by using insulin treatment satisfaction questionnaire

    Time frame: after 6 months of treatment

  6. 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.

    Time frame: after 6 months of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: EVIDENCE

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 14, 2008
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.