Observational Study of Type 2 Diabetes Patients Failing on Oral Anti-Diabetic Agents Initiated on Levemir® or Insulatard® - Full Text View

Purpose

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.

Condition	Intervention
Diabetes Mellitus, Type 2	Drug: insulin detemir Drug: insulin NPH

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Insulin Insulin Detemir Insulin, isophane

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

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

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Change in weight [ Time Frame: The study duration is 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The effect on metabolic control assessed by the changes in glycaemic parameters: HbA1c and blood glucose values [ Time Frame: The study duration is 6 months ] [ Designated as safety issue: No ]
The incidence of hypoglycaemic events [ Time Frame: The study duration is 6 months ] [ Designated as safety issue: Yes ]
Safety parameters by collecting (serious) adverse drug reactions, pregnancies and technical complaints. [ Time Frame: The study duration is 6 months ] [ Designated as safety issue: Yes ]
The general well-being by using the WHO-5 well-being questionnaire. [ Time Frame: The study duration is 6 months ] [ Designated as safety issue: No ]
The treatment satisfaction of subjects treated with insulin detemir or NPH insulin by using insulin treatment satisfaction questionnaire [ Time Frame: The study duration is 6 months ] [ Designated as safety issue: No ]
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: The study duration is 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	700
Study Start Date:	November 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: insulin detemir Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation
B	Drug: insulin NPH Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

Eligibility

Ages Eligible for Study:	6 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Type 2 diabetes patiens failing on oral anti-diabetic agents

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658099

Locations


Romania

	Bucharest, Romania, 010031

Sponsors and Collaborators

Novo Nordisk

Investigators


Study Director:	Emiliana Corina Mocan, MM	Novo Nordisk Farma

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-1976
First Received:	April 8, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00658099
Health Authority:	Romania: National Medicines Agency