Study of Combination Therapy of Gliclazide MR and Basal Insulin Versus Insulin Monotherapy to Treat Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- Drug: Biosynthetic Human Insulin Injection
- Registration Number
- NCT00736515
- Lead Sponsor
- Servier (Tianjin) Pharmaceutical Co. LTD.
- 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 is getting paid more and more attention. A lot of studies have confirmed that Gliclazide MRs have excellent reducing blood glucose efficacy and vascular protection. Based on these theory and practice, this study is designed to demonstrate whether the combination therapy of Gliclazide MR and basal insulin can control the blood glycemia effectively and reduce the dosage of insulin and the hypoglycemia events compared to the premix insulin monotherapy.
- 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 oral antidiabetes drugs treatment for more than 3 months
5. 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
6. Not participated in other clinical studies within the past 3 months
7. Well know this study and sign the informed consent form
Exclusion criteria:
1. Unable to sign the informed consent form
2. Treated by insulin, even transient usage within the past 1 year
3. Type 1 diabetes mellitus
4. Abnormal condition of gastrointestinal tract against the absorption of oral drugs
5. 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
6. 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
7. Usage of the other hormone medicines such as cortical hormone, immunosuppressive agents or cytotoxic drugs within the past 2 months
8. psychotic
9. Allergic history to sulfonylurea drugs
10. Diabetic coma or diabetic ketoacidosis
11. In use of the miconazole
12. Pregnancy or breeding women
Primary endpoint:
Decreasing value of FPG and HbA1c, Dosage of the insulin, Control rate of FPG
Second Endpoints:
1. MBG, SDBG, MAGE and MODD in the 48th CGMS
2. Incidence of hypoglycemia and severe hypoglycemia
3. Weight change
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination therapy Gliclazide MR and Insulin Glargine Injection The subjects allocated into this arm will receive the combination therapy of oral administration of 60\~120mg Gliclazide MR (Diamicron MR) and subcutaneous injection of basal insulin (Insulin Glargine Injection, Lantus) once daily for 3 months monotherapy Biosynthetic Human Insulin Injection The patients allocated into this arm will receive the monotherapy of subcutaneous injection of premixed insulin (Biosynthetic Human Insulin Injection, Novolin 30R) twice daily for 3 months.
- Primary Outcome Measures
Name Time Method Decreasing value of FPG and HbA1c, dosage of insulin and control rate of FPG 3 months
- Secondary Outcome Measures
Name Time Method MBG, SDBG, MAGE and MODD in the 48th CGMS 3 months Incidence of hypoglycemia and severe hypoglycemia 3 months Weight change 3 months
Trial Locations
- Locations (8)
Beijing Hospital
🇨🇳Beijing, Beijing, China
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
The 2nd Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Tongji Hospital of Tongji Medical College of Huazhong University of Science & Technology
🇨🇳Wuhan, Hubei, China
SIR RUN RUN SHAW Hospital Affiliated to Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China