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
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: insulin detemir (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Jozef Lacka, M.D. , CSc., Study Director, Affiliation: Novo Nordisk Slovakia, s.r.o
Overall contact:
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
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.
Clinical Details
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.
Study design: Cohort, Retrospective
Primary outcome: Change in glycaemic control as measured by HbA1c.
Secondary outcome: Percentage of subjects to reach HbA1c below 7.0% and below or equal 6.5%The effect on glycaemic control as measured by FPG Change in body weight Change in waist and hip perimeter
Eligibility
Minimum age: 6 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
Kosice 040 01, Slovakia; Recruiting
Additional Information
Clinical Trials at Novo Nordisk
Starting date: February 2008
Ending date: April 2009
Last updated: September 16, 2008
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