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

Diabetes Mellitus, Type 2 Clinical Trial

— EVIDENCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658099
• Other study ID #: NN304-1976
• Status: Completed
• Phase: N/A
• First received: April 8, 2008
• Last updated: January 30, 2017
• Start date: November 2007
• Est. completion date: June 2008

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 699
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin detemir
Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation
• insulin NPH
Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

Locations

Country	Name	City	State
Romania	Novo Nordisk Investigational Site	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Romania, 

References & Publications (1)

Doina Catrinoiu; Effect of Once-Daily Detemir vs NPH Insulin on Body Weight and Metabolic Control When Added to OADs in Type 2 Diabetes; 2029-PO; 69th Scientific Sessions (2009); American Diabetes Association

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight		after 6 months of treatment
Secondary	The effect on metabolic control assessed by the changes in glycaemic parameters: HbA1c and blood glucose values		after 6 months of treatment
Secondary	The incidence of hypoglycaemic events		after 6 months of treatment
Secondary	Safety parameters by collecting (serious) adverse drug reactions, pregnancies and technical complaints.		after 6 months of treatment
Secondary	The general well-being by using the WHO-5 well-being questionnaire.		after 6 months of treatment
Secondary	The treatment satisfaction of subjects treated with insulin detemir or NPH insulin by using insulin treatment satisfaction questionnaire		after 6 months of treatment
Secondary	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

External Links

•   Clinical Trials at Novo Nordisk