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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02026310

Enrollment

Registered

2014-01-01

Start date

2014-01-31

Completion date

2015-12-31

Last updated

2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

glimepiride, metformin, basal insulin, Hemoglobin A, Glycosylated, glucose fluctuation, hypoglycemia

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.

Interventions

DRUGglimepiride

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.

DRUGglargine and metformin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
24 weeks after treatment, HbA1c values' change compared with baseline	24 weeks after treatment

Secondary

Measure	Time frame
hypoglycemia events	24 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026