Effect of Two Different Fasting Blood Glucose Targets on Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily (TITRATE™)

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

NCT00634842

NN304-3502

Details and patient eligibility

About

This trial is conducted in the United States of America. The aim of this trial is to explore how different fasting blood glucose targets affect glucose control in patients with type 2 diabetes, when patients are empowered to do dose adjustments themselves.

Enrollment: 244 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• 1-3 oral treatments
• Insulin naive
• BMI (Body Mass Index) less than or equal to 45

Exclusion criteria

• Pregnancy
• Retinopathy
• Cardiac disease
• Uncontrolled hypertension
• Recurrent hypoglycaemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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244 participants in 2 patient groups

FPG 70-90 mg/dL

Experimental group

Description:

Aggressive FPG (fasting plasma glucose) titration target range group

Treatment:

Drug: insulin detemir

Drug: insulin detemir

FPG 80-110 mg/dL

Experimental group

Description:

Conventional FPG (fasting plasma glucose) titration target range group

Treatment:

Drug: insulin detemir

Drug: insulin detemir