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

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00455858

NN304-1762

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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87 participants in 1 patient group

insulin detemir

Active Comparator group

Treatment:

Drug: insulin detemir