Clinical trial NCT02026310: Efficacy/Safety Study of Glimepiride to Type 2 Diabetes Patients Based on Metformin And Basal Insulin Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: glimepiride
metformin
basal insulin
Hemoglobin A, Glycosylated
glucose fluctuation
hypoglycemia
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 24 weeks after treatment, HbA1c values' change compared with baseline
timeFrame: 24 weeks after treatment
Secondary outcomes:
measure: hypoglycemia events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Chongqing,
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Li Qifu, PhD
role: STUDY_CHAIR
References:
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.
citation: 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.
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.
citation: Yki-Jarvinen H, Ryysy L, Nikkila K, Tulokas T, Vanamo R, Heikkila 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. doi: 10.7326/0003-4819-130-5-199903020-00002.
citation: Overkamp D, Volk A, Maerker E, Heide PE, Wahl HG, Rett K, Haring 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. doi: 10.2337/diacare.25.11.2065.