Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: insulin detemir

Drug: insulin NPH

Study type

Interventional

Funder types

Industry

Identifiers

NCT00383877

NN304-1684

Details and patient eligibility

About

This trial is conducted in China. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily at bedtime as add-on to oral anti-diabetic drug(s).

Enrollment

263 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 2 diabetes
HbA1C greater than 7.5% and less than or equal to 11.0%
Currently on any oral antidiabetic drug (OAD) more than or equal to 3 months

Exclusion criteria

Previous acute treatment with insulin for more than 7 days.
Treatment with OAD(s) which does not adhere to the approval labeling.
Proliferate retinopathy or maculopathy that has required acute treatment within the last year.
Known hypoglycaemia unawareness or recurrent major hypoglycaemia, that may interfere with study participation as judged by the Investigator.