Study of Combination Therapy of Gliclazide MR and Basal Insulin Versus Insulin Monotherapy to Treat Type 2 Diabetes

NCT ID: NCT00736515

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-08-31

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

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination therapy

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

Group Type: EXPERIMENTAL

Gliclazide MR and Insulin Glargine Injection

Intervention Type: DRUG

Combination therapy of oral administration of 60-120mg Gliclazide Modified Release Tablet once daily before breakfast and subcutaneous injection of Insulin Glargine Injection once daily before dinner (initial dosage 0.2U/KG/D) for 3 months

monotherapy

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.

Group Type: ACTIVE_COMPARATOR

Biosynthetic Human Insulin Injection

Intervention Type: DRUG

Monotherapy of subcutaneous injection of Biosynthetic Human Insulin Injection twice daily (before breakfast and before dinner) (initial dosage 0.4-0.6U/KG/D) for 3 months

Interventions

Gliclazide MR and Insulin Glargine Injection

Combination therapy of oral administration of 60-120mg Gliclazide Modified Release Tablet once daily before breakfast and subcutaneous injection of Insulin Glargine Injection once daily before dinner (initial dosage 0.2U/KG/D) for 3 months

Intervention Type: DRUG

Biosynthetic Human Insulin Injection

Monotherapy of subcutaneous injection of Biosynthetic Human Insulin Injection twice daily (before breakfast and before dinner) (initial dosage 0.4-0.6U/KG/D) for 3 months

Intervention Type: DRUG

Other Intervention Names

Brand Name: Diamicron MR and Lantus; Brand Name: Novolin 30R

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Servier (Tianjin) Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weiping Jia, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Jian Zhou, MD, PHD

Role: STUDY_DIRECTOR

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Yuqian Bao, MD, PHD

Role: STUDY_DIRECTOR

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Huazhang Yang, MD, PHD

Role: STUDY_DIRECTOR

Guangdong Provincial People's Hospital

Jian Kuang, MD, PHD

Role: STUDY_DIRECTOR

Guangdong Provincial People's Hospital

Hongmei Chen, MD

Role: STUDY_DIRECTOR

Guangdong Provincial People's Hospital

Haoming Tian, MD

Role: STUDY_DIRECTOR

West China Hospital

Hong Li, MD

Role: STUDY_DIRECTOR

SIR RUN RUN SHAW Hospital Affiliated to Zhejiang University School of Medicine

Fenping Zheng, MD

Role: STUDY_DIRECTOR

SIR RUN RUN SHAW Hospital Affiliated to Zhejiang University School of Medicine

Qiang Li, MD

Role: STUDY_DIRECTOR

The Second Affiliated Hospital of Harbin Medical University

Xiaohui Guo, MD, PHD

Role: STUDY_DIRECTOR

Peking University First Hospital

Ying Gao, MD, PHD

Role: STUDY_DIRECTOR

Peking University First Hospital

Muxun Zhang, MD

Role: STUDY_DIRECTOR

Tongji Hospital

Lixin Guo, MD, PHD

Role: STUDY_DIRECTOR

Beijing Hospital

Yan Ren, MD, PHD

Role: STUDY_DIRECTOR

West China Hospital

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Beijing Hospital

Beijing, Beijing Municipality, China

Guangdong General Hospital

Guangzhou, Guangdong, China

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Tongji Hospital of Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

SIR RUN RUN SHAW Hospital Affiliated to Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

References

Janka HU, Plewe G, Riddle MC, Kliebe-Frisch C, Schweitzer MA, Yki-Jarvinen H. Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care. 2005 Feb;28(2):254-9. doi: 10.2337/diacare.28.2.254.

Reference Type: BACKGROUND

PMID: 15677775 (View on PubMed)

Zhou J, Zheng F, Guo X, Yang H, Zhang M, Tian H, Guo L, Li Q, Mo Y, Jia W. Glargine insulin/gliclazide MR combination therapy is more effective than premixed insulin monotherapy in Chinese patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs. Diabetes Metab Res Rev. 2015 Oct;31(7):725-33. doi: 10.1002/dmrr.2661. Epub 2015 Jun 16.

Reference Type: RESULT

PMID: 25952634 (View on PubMed)

Other Identifiers

IC4-5702-205-CHN

Identifier Type: -

Identifier Source: org_study_id