Study of Combination Therapy of Gliclazide MR and Basal Insulin Versus Insulin Monotherapy to Treat Type 2 Diabetes

Study Overview
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Brief Summary
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In recent years, with the further research of the pathogenesis of diabetes mellitus and the mechanism of oral antidiabetes drugs, the early combination therapy of oral antidiabetes drugs and insulin is getting paid more and more attention. A lot of studies have confirmed that Gliclazide MRs have excellent reducing blood glucose efficacy and vascular protection. Based on these theory and practice, this study is designed to demonstrate whether the combination therapy of Gliclazide MR and basal insulin can control the blood glycemia effectively and reduce the dosage of insulin and the hypoglycemia events compared to the premix insulin monotherapy.

Detailed Description
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Inclusion criteria: Male or female with type 2 diabetes mellitus 35 years old≤age≤65 years old 19kg/m2≤BMI≤32kg/m2 Uncontrolled blood glycemia (FPG≥7.0mmol/L and 7.5%<HbA1c≤10%) after oral antidiabetes drugs treatment for more than 3 months Treated by diet controlling, 1 secretagogue agent and another oral antidiabetes drug, with the daily dosage of the secretagogue agent not more than 50% of its maximum Not participated in other clinical studies within the past 3 months Well know this study and sign the informed consent form Exclusion criteria: Unable to sign the informed consent form Treated by insulin, even transient usage within the past 1 year Type 1 diabetes mellitus Abnormal condition of gastrointestinal tract against the absorption of oral drugs Insufficient of liver and kidney function: ALT≥2.5 times of the upper limit of the normal value range and serum creatinine≥the upper limit of the normal value range Encountered the cardiovascular events such as the angina pectoris, myocardial infarction, severe ventricular arrhythmia, cerebral hemorrhage, cerebral infarction, heart failure ect. within the past half year Usage of the other hormone medicines such as cortical hormone, immunosuppressive agents or cytotoxic drugs within the past 2 months psychotic Allergic history to sulfonylurea drugs Diabetic coma or diabetic ketoacidosis In use of the miconazole Pregnancy or breeding women Primary endpoint: Decreasing value of FPG and HbA1c, Dosage of the insulin, Control rate of FPG Second Endpoints: MBG, SDBG, MAGE and MODD in the 48th CGMS Incidence of hypoglycemia and severe hypoglycemia Weight change

Official Title
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Phase 4 Study of Comparison of Combination Therapy of Gliclazide MR and Basal Insulin With Pre-mix Insulin Monotherapy for the Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Gliclazide MR and Insulin Glargine Injection
* Drug: Biosynthetic Human Insulin Injection


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male or female with type 2 diabetes mellitus 35 years old≤age≤65 years old 19kg/m2≤BMI≤32kg/m2 Uncontrolled blood glycemia (FPG≥7.0mmol/L and 7.5%<HbA1c≤10%) after oral antidiabetes drugs treatment for more than 3 months Treated by diet controlling, 1 secretagogue agent and another oral antidiabetes drug, with the daily dosage of the secretagogue agent not more than 50% of its maximum Not participated in other clinical studies within the past 3 months Well know this study and sign the informed consent form Exclusion criteria: Unable to sign the informed consent form Treated by insulin, even transient usage within the past 1 year Type 1 diabetes mellitus Abnormal condition of gastrointestinal tract against the absorption of oral drugs Insufficient of liver and kidney function: ALT≥2.5 times of the upper limit of the normal value range and serum creatinine≥the upper limit of the normal value range Encountered the cardiovascular events such as the angina pectoris, myocardial infarction, severe ventricular arrhythmia, cerebral hemorrhage, cerebral infarction, heart failure ect. within the past half year Usage of the other hormone medicines such as cortical hormone, immunosuppressive agents or cytotoxic drugs within the past 2 months psychotic Allergic history to sulfonylurea drugs Diabetic coma or diabetic ketoacidosis In use of the miconazole Pregnancy or breeding women

Ages Eligible for Study
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Minimum Age: 35 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: Combination therapy<br>The subjects allocated into this arm will receive the combination therapy of oral administration of 60 120mg Gliclazide MR (Diamicron MR) and subcutaneous injection of basal insulin (Insulin Glargine Injection, Lantus) once daily for 3 months | Drug: Gliclazide MR and Insulin Glargine Injection<br>* Combination therapy of oral administration of 60-120mg Gliclazide Modified Release Tablet once daily before breakfast and subcutaneous injection of Insulin Glargine Injection once daily before dinner (initial dosage 0.2U/KG/D) for 3 months<br>* Other names: Brand Name: Diamicron MR and Lantus;|
| Active Comparator: monotherapy<br>The patients allocated into this arm will receive the monotherapy of subcutaneous injection of premixed insulin (Biosynthetic Human Insulin Injection, Novolin 30R) twice daily for 3 months. | Drug: Biosynthetic Human Insulin Injection<br>* Monotherapy of subcutaneous injection of Biosynthetic Human Insulin Injection twice daily (before breakfast and before dinner) (initial dosage 0.4-0.6U/KG/D) for 3 months<br>* Other names: Brand Name: Novolin 30R;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreasing value of FPG and HbA1c, dosage of insulin and control rate of FPG |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MBG, SDBG, MAGE and MODD in the 48th CGMS |  | 3 months | 
| Incidence of hypoglycemia and severe hypoglycemia |  | 3 months | 
| Weight change |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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combination therapy,monotherapy,gliclazide MR,insulin,CGMS