Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea

January 31, 2024 updated by: Novo Nordisk A/S

A 20-week, Multi-centre, Open-labelled, Non-comparative Evaluation of the Safety and Efficacy of Insulin Detemir in Combination With Oral Anti-diabetic Drug(s), in Subjects With Type 2 Diabetes Mellitus Who Were Inadequately Controlled on Current Therapy in Korea

This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Type 2 diabetes (diagnosed more than 12 months ago)
  • HbA1c greater than 7.0 and less than 12.0% at screening
  • Currently on any OAD in more than 3 months ago
  • BMI (Body Mass Index) less than 35kg/m2

Exclusion Criteria:

  • Previous treatment with insulin in more than 7 days within the last 3 months
  • Uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure less than 110mmHg)

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: insulin detemir
Drug: insulin detemir
Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).
Other Names:
  • Levemir®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20
Time Frame: week 0, week 20
Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20
week 0, week 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12
Time Frame: week 0, week 12
Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline
week 0, week 12
Change in Fasting Plasma Glucose (FPG)
Time Frame: week 0, week 12, week 20
Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20
week 0, week 12, week 20
Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%
Time Frame: week 12, week 20
Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0%
week 12, week 20
Occurence of Hypoglycaemic Episodes
Time Frame: weeks 0-20
Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment.
weeks 0-20

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

November 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

April 3, 2007

First Submitted That Met QC Criteria

April 3, 2007

First Posted (Estimated)

April 4, 2007

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1762

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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