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

NCT00736515 | Completed Phase 4 DMC

• 1 other identifier: IC4-5702-205-CHN
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 8

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.

Conditions

Type 2 Diabetes

Keywords

combination therapy,monotherapy,gliclazide MR,insulin,CGMS

Outcome Measures

Primary Outcomes (1)

• Decreasing value of FPG and HbA1c, dosage of insulin and control rate of FPG

  3 months

Secondary Outcomes (3)

• MBG, SDBG, MAGE and MODD in the 48th CGMS

  3 months

• Incidence of hypoglycemia and severe hypoglycemia

  3 months

• Weight change

  3 months

Study Arms (2)

Combination therapy

EXPERIMENTAL

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

Drug: Gliclazide MR and Insulin Glargine Injection

monotherapy

ACTIVE COMPARATOR

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.

Drug: Biosynthetic Human Insulin Injection

Interventions

Gliclazide MR and Insulin Glargine Injection 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

Also known as: Brand Name: Diamicron MR and Lantus

Combination therapy

Biosynthetic Human Insulin Injection 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

Also known as: Brand Name: Novolin 30R

monotherapy

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female with type 2 diabetes mellitus
• years old≤age≤65 years old
• kg/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

You may not qualify if:

• 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

Sponsors & Collaborators

• Servier (Tianjin) Pharmaceutical Co. LTD.: lead

Study Sites (8)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China

Location

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

Wuhan, Hubei, 430030, China

Location

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

Shanghai, Shanghai Municipality, 200233, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

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

Hangzhou, Zhejiang, 310016, China

Location

Related Publications (2)

• 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.

  PMID: 15677775 BACKGROUND

• 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.

  PMID: 25952634 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Weiping Jia, MD, PHD

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

  PRINCIPAL INVESTIGATOR

• Jian Zhou, MD, PHD

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

  STUDY DIRECTOR

• Yuqian Bao, MD, PHD

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

  STUDY DIRECTOR

• Huazhang Yang, MD, PHD

  Guangdong Provincial People's Hospital

  STUDY DIRECTOR

• Jian Kuang, MD, PHD

  Guangdong Provincial People's Hospital

  STUDY DIRECTOR

• Hongmei Chen, MD

  Guangdong Provincial People's Hospital

  STUDY DIRECTOR

• Haoming Tian, MD

  West China Hospital

  STUDY DIRECTOR

• Hong Li, MD

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

  STUDY DIRECTOR

• Fenping Zheng, MD

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

  STUDY DIRECTOR

• Qiang Li, MD

  The Second Affiliated Hospital of Harbin Medical University

  STUDY DIRECTOR

• Xiaohui Guo, MD, PHD

  Peking University First Hospital

  STUDY DIRECTOR

• Ying Gao, MD, PHD

  Peking University First Hospital

  STUDY DIRECTOR

• Muxun Zhang, MD

  Tongji Hospital

  STUDY DIRECTOR

• Lixin Guo, MD, PHD

  Beijing Hospital

  STUDY DIRECTOR

• Yan Ren, MD, PHD

  West China Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 18, 2008
• Study Start: October 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 3, 2020

Record last verified: 2020-03

Locations

CN (8)