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

Qifu Li

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: glimepiride; Drug: glargine and metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02026310

yml2013

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

glimepiride

Experimental group

Description:

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.

Treatment:

Drug: glargine and metformin

Drug: glimepiride

Metformin and glargine

Active Comparator group

Description:

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

Treatment:

Drug: glargine and metformin