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 - Tabular View

Tracking Information

First Received Date ^ICMJE

May 27, 2008

Last Updated Date

November 9, 2009

Start Date ^ICMJE

February 2008

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00687284 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Retrospective

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: insulin detemir

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

2000

Estimated Completion Date

April 2010

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Slovakia

Administrative Information

NCT ID ^ICMJE

NCT00687284

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study ID Numbers ^ICMJE

NN304-3515

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Jozef Lacka, M.D. , CSc.

Novo Nordisk Slovakia, s.r.o

Information Provided By

Novo Nordisk

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP