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

Completed

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

• Registration Number: NCT00658099
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-11
• Study First Posted: 2008-04-14
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 699

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

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
Change in weight	after 6 months of treatment

Secondary Outcome Measures

Name	Time	Method
The incidence of hypoglycaemic events	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
Safety parameters by collecting (serious) adverse drug reactions, pregnancies and technical complaints.	after 6 months of treatment
The general well-being by using the WHO-5 well-being questionnaire.	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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇷🇴 Bucharest, Romania