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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Effect of Two Different Fasting Blood Glucose Titration Targets in Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily in Combination With 1-3 Oral Agents

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FPG 70-90 mg/dL<br>Aggressive FPG (fasting plasma glucose) titration target range group | Drug: insulin detemir<br>* Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL<br>|
| Experimental: FPG 80-110 mg/dL<br>Conventional FPG (fasting plasma glucose) titration target range group | Drug: insulin detemir<br>* Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 80-110 mg/dL<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7% | Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment | week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% | Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment | week 20 | 
| Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline | Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20 | week -2, week 20 | 
| Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only) | Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) occurring during the treatment period from week 0 to week 20. Classification was as follows: If subject was unable to treat himself: Major incidence. If subject could treat himself and plasma glucose was less than 3.1 mmol/l: Minor incidence. If subject could treat himself and plasma glucose was equal to or greater than 3.1 mmol/l, or there was no plasma glucose measurement: Symptoms only. | weeks 0-20 |