Clinical trial

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

Name

NN304-1762

Description

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.

Trial arms

Trial start

2007-11-01

Estimated PCD

2008-10-01

Trial end

2008-10-01

Status

Completed

Phase

Early phase I

Treatment

insulin detemir

Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).

Arms:

insulin detemir

Other names:

Levemir®

Size

Primary endpoint

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20

week 0, week 20

Eligibility criteria

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 87, 'type': 'ACTUAL'}}

Updated at

2024-02-01

1 organization

1 product

3 indications

Product

Indication

Indication

Indication

Organization