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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026310
• Other study ID #: yml2013
• Status: Completed
• Phase: N/A
• First received: December 26, 2013
• Last updated: January 26, 2016
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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.
• glargine and metformin

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing,	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Qifu Li

Country where clinical trial is conducted

China, 

References & Publications (5)

Abdul-Ghani MA, DeFronzo RA. Pathogenesis of insulin resistance in skeletal muscle. J Biomed Biotechnol. 2010;2010:476279. doi: 10.1155/2010/476279. Epub 2010 Apr 26. Review. — View Citation

Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10. — View Citation

Overkamp D, Volk A, Maerker E, Heide PE, Wahl HG, Rett K, Häring HU. Acute effect of glimepiride on insulin-stimulated glucose metabolism in glucose-tolerant insulin-resistant offspring of patients with type 2 diabetes. Diabetes Care. 2002 Nov;25(11):2065-73. — View Citation

Yang W, Lu J, Weng J, Jia W, Ji L, Xiao J, Shan Z, Liu J, Tian H, Ji Q, Zhu D, Ge J, Lin L, Chen L, Guo X, Zhao Z, Li Q, Zhou Z, Shan G, He J; China National Diabetes and Metabolic Disorders Study Group. Prevalence of diabetes among men and women in China. N Engl J Med. 2010 Mar 25;362(12):1090-101. doi: 10.1056/NEJMoa0908292. — View Citation

Yki-Järvinen H, Ryysy L, Nikkilä K, Tulokas T, Vanamo R, Heikkilä M. Comparison of bedtime insulin regimens in patients with type 2 diabetes mellitus. A randomized, controlled trial. Ann Intern Med. 1999 Mar 2;130(5):389-96. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 weeks after treatment, HbA1c values' change compared with baseline		24 weeks after treatment	Yes
Secondary	hypoglycemia events		24 weeks	Yes