The Effect of Insulin Detemir on Blood Glucose Control in Taiwanese Patients With Type 2 Diabetes Failing on OAD

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

Safety and Therapeutic Effect of Insulin Detemir in Taiwanese Patients With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets With OAD With/Without Once-daily NPH Insulin Treatment

The trial is conducted in Asia. The aim of the trial is to evaluate the effect of insulin detemir on blood glucose control in Taiwanese patients with type 2 diabetes failing on OAD with/without once-daily NPH Insulin treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

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

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

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Type 2 diabetes
  • HbA1C: 7.0-11.0%
  • Previous diabetes treatment for at least 6 months
  • BMI max. 35 kg/m2
  • Treatment with an oral anti-diabetic drug (OAD)

Exclusion Criteria:

  • Type 1 diabetes
  • Receipt of any investigational drug within the last three months prior to this trial

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of serious adverse events, including major hypoglycaemic events
Time Frame: during 16 weeks of insulin detemir therapy
during 16 weeks of insulin detemir therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of hypoglycaemic episodes
Change in weight
Change in fasting plasma glucose (FPG)
Change in HbA1C
Time Frame: after 16 weeks
after 16 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), 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

December 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

August 27, 2007

First Submitted That Met QC Criteria

August 27, 2007

First Posted (Estimated)

August 28, 2007

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

  • NN304-1764

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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Locations

3
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