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

Novo Nordisk A/S263 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

263

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin detemirDRUG

insulin NPHDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Beijing, China

Outcomes

Primary Outcomes

HbA1c

Time frame: after 20 weeks of treatment

Secondary Outcomes

FBG

Time frame: after 20 weeks of treatment

Safety profile

Time frame: during 20 weeks treatment

Proportion of subjects achieving HbA1c less than or equal to 7.0%

Time frame: after 20 weeks of treatment

Within-subject variation of self measured blood glucose (SMBG) before breakfast during the trial at the end of the trial

Time frame: before breakfast during the trial at the end of the trial

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.