Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)

Study Overview
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Brief Summary
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Primary Objective: To identify a best fasting plasma glucose (FPG) target for Chinese type 2 diabetes patients using insulin glargine which can provide the highest control rate of glycated hemoglobin (HbA1c) < 7%. Secondary Objectives: The control rate of HbA1c ≤6.5% achievement. The control rate of HbA1c <7.0% in patients achieving their FPG target. The percentage of HbA1c <7% without hypoglycemia. The percentage of patients achieving the FPG target without hypoglycemia. The percentage of patients achieving the FPG target and post prandial glucose (PPG) target (2-hour post breakfast <10 mmol/L).

Detailed Description
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The study duration for each patient will be 27 weeks.

Official Title
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Titration Target for Chinese Type 2 Diabetes Mellitus Patients Using Insulin Glargine to Achieve Glycaemic Goals: An Assessment of Three Different Fasting Plasma Glucose Targets - BEYOND III/FPG GOAL Study

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: INSULIN GLARGINE


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : 18 to 65 years old. Type 2 diabetes patients insufficient controlled by 1-3 oral anti-hyperglycemic drugs (OADs) with stable dose at least 3 months: If on 1 OAD, provided with the following doses (including but not limited to): α-glucosidase inhibitor: 100mg, three times a day (tid); metformin: 1.5-2.0 g/day; sulphonylureas: sub-maximum (half dose above) to maximum tolerated dose; thiazolidinediones: eg. pioglitazone, 30-40 mg/day. Besides the medications listed above, if on 1 OAD, others should be maximum tolerated dose allowed in package insert. If on 2-3 OADs, any range of dose is acceptable. HbA1c >7%, and ≤10.5%. FPG >7 mmol/L. Body mass index (BMI) ≥20 kg/m^2, and ≤40 kg/m^2. Diabetes duration ≥1 year. Physician decides to and the patient is willing to start basal insulin (BI) treatment. Willing to join the study and sign the informed consent. Exclusion criteria: Type 1 diabetes patients. Patients with acute diabetic complications (including unexplained severe hypoglycemia in the last 6 months). Previous treatment with insulin for more than 1 month cumulatively in last 1 year, or treatment with insulin in the last 3 months before the screening. Known hypoglycemia unawareness or recurrent hypoglycemia. Hypersensitivity to study drug or its excipients. Any clinically significant acute major organ or systemic disease, or any other situation judged by the Investigator, that is difficult for the 24 weeks follow-up. Pregnancy or breastfeeding women. Have any mental disorders, lack self-control or not able to express accurately. Involved in another clinical trial simultaneously or within a 1 month before start of trial. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Insulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of <=5.6 mmol/L | Drug: INSULIN GLARGINE<br>* Pharmaceutical form: solution Route of administration: subcutaneous<br>* Other names: HOE901;|
| Experimental: Group 2<br>Insulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of <=6.1 mmol/L | Drug: INSULIN GLARGINE<br>* Pharmaceutical form: solution Route of administration: subcutaneous<br>* Other names: HOE901;|
| Experimental: Group 3<br>Insulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of <=7.0 mmol/L | Drug: INSULIN GLARGINE<br>* Pharmaceutical form: solution Route of administration: subcutaneous<br>* Other names: HOE901;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with HbA1c <7% achievement |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving HbA1c <=6.5% |  | 24 weeks | 
| Percentage of patients achieving FPG target with HbA1c <7% |  | 24 weeks | 
| Percentage of patients achieving HbA1c <7% without hypoglycemia |  | 24 weeks | 
| Percentage of patients achieving the FPG target without hypoglycemia |  | 24 weeks | 
| Percentage of patients achieving FPG target |  | 24 weeks | 
| Percentage of patients achieving PPG target (2-hour post-breakfast <10 mmol/L) |  | 24 weeks | 
| Change from baseline in HbA1c |  | Baseline to 24 weeks | 
| Change in FPG |  | 8 weeks to 24 weeks | 
| Change in PPG |  | Baseline to 24 weeks | 
| Change in insulin doses in each arm |  | 1 week to 24 weeks | 
| Change in body weight in each treatment arm |  | Baseline to 24 weeks | 
| Percentage of patients experienced hypoglycemic events |  | 24 weeks |