Skip to main content
OpenTrials
Completed

NCT Number: NCT02026310

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glimepiride

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

Drug

Other names: lantus

Primary outcomes

  1. 24 weeks after treatment, HbA1c values' change compared with baseline

    Time frame: 24 weeks after treatment

Secondary outcomes

  1. hypoglycemia events

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Qifu Li

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 1, 2014
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.