Efficacy/Safety Study of Glimepiride to Type 2 Diabetes Patients Based on Metformin And Basal Insulin Treatment

Study Overview
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Brief Summary
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All the guidelines suggest that metformin as the basis of type 2 diabetes medication, and evidence is sufficient.At the same time the basal insulin injection once a day are more and more widely used in diabetes patients in China. This study aims to evaluate the efficacy and safety of adding glimepiride to type 2 diabetes patients with inadequate glycemic control with combined therapy of metformin and basal insulin.

Official Title
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Efficacy/Safety Study of Adding Glimepiride to Type 2 Diabetes Patients With Inadequate Glycemic Control Based on Combination With Metformin And Basal Insulin

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: glimepiride
* Drug: glargine and metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Understand the whole test process, voluntary and signed informed consent form Men and women aged 35 to 70 years old 20≤BMI<35 Kg/m2 Diagnosed with type 2 diabetes Undergoing metformin(Dose not less than 1000 mg/day)in combination with basal insulin injection once a day HbA1c7.0-11% Patients should be able to self blood glucose monitoring Exclusion Criteria: sulfonylureas,glinides,TZDs use within 3 months before the study Pregnant or lactating women A history of ketoacidosis Allergy to sulfonylureas or sulfa drug patients Apparent dysfunction of liver and kidney patients(ALT>2 times upper normal limit,serum creatinine>1.2 times upper normal limit) Poor blood pressure control(systolic pressure>180mmHg or diastolic blood pressure>110mmHg) heart disease,cardiac insufficiency,unstable angina pectoris,ECG indicates left ventricle hypertrophy,severe anemia(Hb<9.0g/d1) Severe diabetic nerve complications(ulcer of lower limb,neurogenic bladder) BMI<20 orBMI≥35kg/m2 Alcohol or drug abuse ,or can't collaborate due to mental disorder Digestion and absorption function obstacle or Other endocrine disorders Other chronic diseases required long-term glucocorticoid treatment

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 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: glimepiride<br>on the basis of metformin and glargine, the initial dose of glimepiride is 2 mg,qd (before breakfast), and adjust the dosage for fasting plasma glucose, dosage-adding indicator is the FPG≥7.2, maximum dose of glimepiride is 4 mg/d per day. | Drug: glimepiride<br>* on the basis of metformin and glargine, glimepiride is added; with the maximun dose of glimepiride, if the targeted FPG is not reached, glargine dose will be increased.<br>Drug: glargine and metformin<br> <br> * Other names: lantus;|
| Active Comparator: Metformin and glargine<br>on the basis of Metformin and glargine,no glempiride addition. dose of glargine was adjust according to the FPG, with the target less than 7.2mmol/l | Drug: glargine and metformin<br> <br> * Other names: lantus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 weeks after treatment, HbA1c values' change compared with baseline |  | 24 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypoglycemia events |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glimepiride, metformin, basal insulin, Hemoglobin A, Glycosylated, glucose fluctuation, hypoglycemia