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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionDiabetes Mellitus, Type 2
InterventionDrug: glimepiride
Drug: glargine and metformin
PhaseN/A
SponsorQifu Li
Responsible PartyChongqing Medical University
ClinicalTrials.gov IdentifierNCT02026310
First ReceivedDecember 26, 2013
Last UpdatedDecember 31, 2013
Last verifiedDecember 2013

Tracking Information[ + expand ][ + ]

First Received DateDecember 26, 2013
Last Updated DateDecember 31, 2013
Start DateMay 2013
Estimated Primary Completion DateAugust 2014
Current Primary Outcome Measures24 weeks after treatment, HbA1c values' change compared with baseline [Time Frame: 24 weeks after treatment] [Designated as safety issue: Yes]
Current Secondary Outcome Measureshypoglycemia events [Time Frame: 24 weeks] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleEfficacy/Safety Study of Glimepiride to Type 2 Diabetes Patients Based on Metformin And Basal Insulin Treatment
Official TitleEfficacy/Safety Study of Adding Glimepiride to Type 2 Diabetes Patients With Inadequate Glycemic Control Based on Combination With Metformin And Basal Insulin
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionDiabetes Mellitus, Type 2
InterventionDrug: 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.
Drug: glargine and metformin
Other Names:
lantus
Study Arm (s)
  • Experimental: glimepiride
    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.
  • Active Comparator: Metformin and glargine
    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

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment40
Estimated Completion DateAugust 2014
Estimated Primary Completion DateAugust 2014
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
GenderBoth
Ages35 Years
Accepts Healthy VolunteersNo
ContactsContact: Li Qifu, PhD
+86 023 89011510
liqifu@yeah.net
Location CountriesChina

Administrative Information[ + expand ][ + ]

NCT Number NCT02026310
Other Study ID Numbersyml2013
Has Data Monitoring CommitteeYes
Information Provided ByChongqing Medical University
Study SponsorQifu Li
CollaboratorsNot Provided
Investigators Study Chair: Li Qifu, PhD The First Affiliated Hospital of Chongqing Medical University
Verification DateDecember 2013

Locations[ + expand ][ + ]

The First Affiliated Hospital of Chongqing Medical University
Chongqing,, Chongqing, China, 400016
Contact: Qifu Li, PhD | +86 023 89011552 | liqifu@yeah.net
Sub-Investigator: Yang Shumin, PhD
Recruiting