Observational Study of Safety and Efficacy of Levemir® in Type 2 Diabetes (DIABESITY)

October 31, 2023 updated by: Novo Nordisk A/S

An Observational, Safety and Efficacy Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus.

The study is conducted in Asia. The aim of this observational study is to evaluate the weight change from baseline while using Levemir® in subjects with type 2 diabetes mellitus under normal clinical practice conditions in India.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10008

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

  • India
      • Bangalore, India, 560001

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

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Type 2 diabetics

Description

Inclusion Criteria:

  • Any subject with type 2 diabetes

Exclusion Criteria:

  • Subjects with a hypersensitivity to insulin detemir or any of its excipient
  • Children below 6 years
  • Subjects who are pregnant, lactating or planning to become pregnant

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

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: insulin detemir
Start dose and frequency of insulin detemir is to be decided by physician. The choice of patient is also at the discretion of Physician
Other Names:
  • Levemir®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight change from baseline
Time Frame: after 26 weeks
after 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of serious adverse events
Time Frame: after 26 weeks
after 26 weeks
Number of all adverse events
Time Frame: after 26 weeks
after 26 weeks
Number of all hypoglycemic episodes (24 hr, daytime and nocturnal)
Time Frame: after 26 weeks
after 26 weeks
HbA1c change from baseline
Time Frame: after 26 weeks
after 26 weeks
FBG (Fasting Blood Glucose) change from baseline
Time Frame: after 26 weeks
after 26 weeks
Percentage of patients achieving targets of HbA1c less than 7 % and less than 6.5 %
Time Frame: after 26 weeks
after 26 weeks
Insulin dose and frequency at the end of the study
Time Frame: after 26 weeks
after 26 weeks

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), MD, Novo Nordisk A/S

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.

Helpful Links

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

April 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 27, 2008

First Posted (Estimated)

May 30, 2008

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-3530

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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