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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

glimepiride

Intervention Type DRUG

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.

glargine and metformin

Intervention Type DRUG

Metformin and glargine

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

Group Type ACTIVE_COMPARATOR

glargine and metformin

Intervention Type DRUG

Interventions

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glimepiride

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.

Intervention Type DRUG

glargine and metformin

Intervention Type DRUG

Other Intervention Names

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lantus

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No