Observational Study of Glycaemic Control in Patients Uncontrolled on Oral Antidiabetic Agents and Starting With 1 (Once) Daily Levemir® (Insulin Detemir) as the Treatment of Type 2 Diabetes Mellitus - Full Text View

Observational Study of Glycaemic Control in Patients Uncontrolled on Oral Antidiabetic Agents and Starting With 1 (Once) Daily Levemir® (Insulin Detemir) as the Treatment of Type 2 Diabetes Mellitus (START)

This study is ongoing, but not recruiting participants.

First Received: May 27, 2008 Last Updated: November 9, 2009 History of Changes

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00687284

Purpose

This study is conducted in Europe. An observational study evaluating glycaemic control in patients using Levemir® as initiation insulin therapy as the treatment of type 2 diabetes in Slovakia.

Condition	Intervention
Diabetes Mellitus, Type 2	Drug: insulin detemir

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Observational Study on Evaluation of Glycaemic Control in Patients Using Levemir® (Insulin Detemir) as Initiation Insulin Therapy by Levemir® (Insulin Detemir) Administered 1 (Once) Daily as the Treatment of Type 2 Diabetes Mellitus.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin Detemir

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Change in glycaemic control as measured by HbA1c. [ Time Frame: For the duration of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of subjects to reach HbA1c below 7.0% and below or equal 6.5% [ Time Frame: After 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
The effect on glycaemic control as measured by FPG [ Time Frame: After 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
Change in body weight [ Time Frame: After 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
Change in waist and hip perimeter [ Time Frame: After 12 weeks and 24 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2000
Study Start Date:	February 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	6 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Diabetes mellitus type 2

Criteria

Inclusion Criteria:

Patients with type 2 diabetes
Patients inadequately controlled by OAD
Patients willing to sign informed consent
Selection of study participants at the discretion of the physician
Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria:

Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit;
Subjects who were previously enrolled in this study
Subjects with a hypersensitivity to insulin detemir or to any of the excipients.
Women who are pregnant, breastfeeding or have the intention of becoming pregnant within next 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687284

Locations

Slovakia

Kosice, Slovakia, 040 01

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Jozef Lacka, M.D. , CSc.

Novo Nordisk Slovakia, s.r.o

More Information

Additional Information:

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

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-3515
Study First Received:	May 27, 2008
Last Updated:	November 9, 2009
ClinicalTrials.gov Identifier:	NCT00687284 History of Changes
Health Authority:	Slovakia: State Institute for Drug Control

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on November 09, 2009