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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qifu Li
• Treatments: Glimepiride; Insulin; Insulin Glargine; Metformin

Criteria

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