Status:
COMPLETED
Study of Combination Therapy of Gliclazide MR and Basal Insulin Versus Insulin Monotherapy to Treat Type 2 Diabetes
Lead Sponsor:
Servier (Tianjin) Pharmaceutical Co. LTD.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
35-65 years
Phase:
PHASE4
Brief Summary
In recent years, with the further research of the pathogenesis of diabetes mellitus and the mechanism of oral antidiabetes drugs, the early combination therapy of oral antidiabetes drugs and insulin i...
Detailed Description
Inclusion criteria: 1. Male or female with type 2 diabetes mellitus 2. 35 years old≤age≤65 years old 3. 19kg/m2≤BMI≤32kg/m2 4. Uncontrolled blood glycemia (FPG≥7.0mmol/L and 7.5%\<HbA1c≤10%) after or...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female with type 2 diabetes mellitus
- 35 years old≤age≤65 years old
- 19kg/m2≤BMI≤32kg/m2
- Uncontrolled blood glycemia (FPG≥7.0mmol/L and 7.5%\<HbA1c≤10%) after oral antidiabetes drugs treatment for more than 3 months
- Treated by diet controlling, 1 secretagogue agent and another oral antidiabetes drug, with the daily dosage of the secretagogue agent not more than 50% of its maximum
- Not participated in other clinical studies within the past 3 months
- Well know this study and sign the informed consent form
- Exclusion criteria:
- Unable to sign the informed consent form
- Treated by insulin, even transient usage within the past 1 year
- Type 1 diabetes mellitus
- Abnormal condition of gastrointestinal tract against the absorption of oral drugs
- Insufficient of liver and kidney function: ALT≥2.5 times of the upper limit of the normal value range and serum creatinine≥the upper limit of the normal value range
- Encountered the cardiovascular events such as the angina pectoris, myocardial infarction, severe ventricular arrhythmia, cerebral hemorrhage, cerebral infarction, heart failure ect. within the past half year
- Usage of the other hormone medicines such as cortical hormone, immunosuppressive agents or cytotoxic drugs within the past 2 months
- psychotic
- Allergic history to sulfonylurea drugs
- Diabetic coma or diabetic ketoacidosis
- In use of the miconazole
- Pregnancy or breeding women
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00736515
Start Date
October 1 2008
End Date
August 1 2011
Last Update
April 3 2020
Active Locations (8)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
2
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
3
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
4
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150086