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)

October 27, 2016 updated by: Novo Nordisk A/S

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.

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2188

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kosice, Slovakia, 040 01
        • Novo Nordisk INvestigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetes mellitus type 2

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Names:
  • Levemir®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in glycaemic control as measured by HbA1c.
Time Frame: For the duration of the study
For the duration of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects to reach HbA1c below 7.0% and below or equal 6.5%
Time Frame: After 12 weeks and 24 weeks
After 12 weeks and 24 weeks
The effect on glycaemic control as measured by FPG
Time Frame: After 12 weeks and 24 weeks
After 12 weeks and 24 weeks
Change in body weight
Time Frame: After 12 weeks and 24 weeks
After 12 weeks and 24 weeks
Change in waist and hip perimeter
Time Frame: After 12 weeks and 24 weeks
After 12 weeks and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 27, 2008

First Posted (Estimate)

May 30, 2008

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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