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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: glimepiride; Drug: glargine and metformin

• Registration Number: NCT02026310
• Lead Sponsor: Qifu Li

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-26
• Study First Submitted QC: 2013-12-31
• Study Start: 2014-01
• Study First Posted: 2014-01-01
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
glimepiride	glimepiride	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.
glimepiride	glargine and metformin	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.
Metformin and glargine	glargine and metformin	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

Primary Outcome Measures

Name	Time	Method
24 weeks after treatment, HbA1c values' change compared with baseline	24 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
hypoglycemia events	24 weeks

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing,, Chongqing, China