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

Diabetes Mellitus, Type 2 Clinical Trial

— START  

Official title:

Observational Study on Evaluation of Glycaemic Control in Patients Using Levemir® (Insulin Detemir) as Initiation Insulin Therapy by Levemir® (Insulin Detemir) Administered Once Daily as the Treatment for Type 2 Diabetes Mellitus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687284
• Other study ID #: NN304-3515
• Status: Completed
• Phase: N/A
• First received: May 27, 2008
• Last updated: October 27, 2016
• Start date: February 2008
• Est. completion date: June 2010

Study information

• Verified date: October 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: State Institute for Drug Control
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2188
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Slovakia	Novo Nordisk Investigational Site	Kosice

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycaemic control as measured by HbA1c.		For the duration of the study	No
Secondary	Percentage of subjects to reach HbA1c below 7.0% and below or equal 6.5%		After 12 weeks and 24 weeks	No
Secondary	The effect on glycaemic control as measured by FPG		After 12 weeks and 24 weeks	No
Secondary	Change in body weight		After 12 weeks and 24 weeks	No
Secondary	Change in waist and hip perimeter		After 12 weeks and 24 weeks	No

External Links

•   Clinical Trials at Novo Nordisk