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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

glimepiride

glargine and metformin

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring glimepiride, metformin, basal insulin, Hemoglobin A, Glycosylated, glucose fluctuation, hypoglycemia

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

The First Affiliated Hospital of Chongqing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

glimepiride

Metformin and glargine

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

hypoglycemia events

Full Information

NCT ID

NCT02026310

First Posted

December 26, 2013

Last Updated

January 26, 2016

Sponsor

Qifu Li

1. Study Identification

Unique Protocol Identification Number

NCT02026310

Brief Title

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

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Qifu Li

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

glimepiride

Arm Type

Experimental

Arm Description

Arm Title

Metformin and glargine

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

glimepiride

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

glargine and metformin

Other Intervention Name(s)

lantus

Primary Outcome Measure Information:

Title

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

Time Frame

24 weeks after treatment

Secondary Outcome Measure Information:

Title

hypoglycemia events

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Qifu, PhD

Organizational Affiliation

First Affiliated Hospital of Chongqing Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

The First Affiliated Hospital of Chongqing Medical University

City

Chongqing,

State/Province

Chongqing

ZIP/Postal Code

400016

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

20335585

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.

Results Reference

background

PubMed Identifier

20445742

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.

Results Reference

background

PubMed Identifier

18784090

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.

Results Reference

background

PubMed Identifier

10068412

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.

Results Reference

background

PubMed Identifier

12401758

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.

Results Reference

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

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