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

NCT02026310 | Completed DMC

• 1 other identifier: yml2013
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  24 weeks after treatment

Secondary Outcomes (1)

• hypoglycemia events

  24 weeks

Study Arms (2)

glimepiride

EXPERIMENTAL

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.

Drug: glimepiride; Drug: glargine and metformin

Metformin and glargine

ACTIVE COMPARATOR

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

Drug: glargine and metformin

Interventions

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.

glimepiride

glargine and metformin DRUG

Also known as: lantus

Metformin and glargine; glimepiride

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand the whole test process, voluntary and signed informed consent form
• Men and women aged 35 to 70 years old
• ≤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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qifu Li: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (5)

• 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.

  PMID: 20335585 BACKGROUND

• 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.

  PMID: 20445742 BACKGROUND

• 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.

  PMID: 18784090 BACKGROUND

• 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.

  PMID: 10068412 BACKGROUND

• 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.

  PMID: 12401758 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoglycemia

Interventions

glimepiride; Insulin Glargine; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Li Qifu, PhD

  First Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Qifu Li, Chongqing Medical University

Study Record Dates

• First Submitted: December 26, 2013
• First Posted: January 1, 2014
• Study Start: January 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

CN (1)