Clinical trial

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

Name

NN304-1764

Description

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.

Trial arms

Trial start

2006-12-01

Estimated PCD

2007-08-01

Trial end

2007-08-01

Status

Completed

Phase

Early phase I

Treatment

insulin detemir

Size

Primary endpoint

Incidence of serious adverse events, including major hypoglycaemic events

during 16 weeks of insulin detemir therapy

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}

Updated at

2023-11-02

1 organization

1 product

3 indications

Organization

Product

Indication

Indication

Indication