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. |
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Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: glimepiride Drug: glargine and metformin |
Phase | N/A |
Sponsor | Qifu Li |
Responsible Party | Chongqing Medical University |
ClinicalTrials.gov Identifier | NCT02026310 |
First Received | December 26, 2013 |
Last Updated | December 31, 2013 |
Last verified | December 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | December 26, 2013 |
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Last Updated Date | December 31, 2013 |
Start Date | May 2013 |
Estimated Primary Completion Date | August 2014 |
Current Primary Outcome Measures | 24 weeks after treatment, HbA1c values' change compared with baseline [Time Frame: 24 weeks after treatment] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures | hypoglycemia events [Time Frame: 24 weeks] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy/Safety Study of Glimepiride to Type 2 Diabetes Patients Based on Metformin And Basal Insulin Treatment |
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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 |
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 Description | Not Provided |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | 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. Drug: glargine and metformin Other Names: lantus |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 40 |
Estimated Completion Date | August 2014 |
Estimated Primary Completion Date | August 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 |
Gender | Both |
Ages | 35 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Li Qifu, PhD +86 023 89011510 liqifu@yeah.net |
Location Countries | China |
Administrative Information[ + expand ][ + ]
NCT Number | NCT02026310 |
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Other Study ID Numbers | yml2013 |
Has Data Monitoring Committee | Yes |
Information Provided By | Chongqing Medical University |
Study Sponsor | Qifu Li |
Collaborators | Not Provided |
Investigators | Study Chair: Li Qifu, PhD The First Affiliated Hospital of Chongqing Medical University |
Verification Date | December 2013 |
Locations[ + expand ][ + ]
The First Affiliated Hospital of Chongqing Medical University | Chongqing,, Chongqing, China, 400016 Contact: Qifu Li, PhD | +86 023 89011552 | liqifu@yeah.netSub-Investigator: Yang Shumin, PhD Recruiting |
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