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NCT Number: NCT00736515

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Hospital, Beijing, Beijing Municipality, China

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About this study

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

Primary endpoint:

Decreasing value of FPG and HbA1c, Dosage of the insulin, Control rate of FPG

Second Endpoints:

  • MBG, SDBG, MAGE and MODD in the 48th CGMS
  • Incidence of hypoglycemia and severe hypoglycemia
  • Weight change

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Brand Name: Diamicron MR and Lantus

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

Other names: Brand Name: Novolin 30R

Primary outcomes

  1. Decreasing value of FPG and HbA1c, dosage of insulin and control rate of FPG

    Time frame: 3 months

Secondary outcomes

  1. MBG, SDBG, MAGE and MODD in the 48th CGMS

    Time frame: 3 months

  2. Incidence of hypoglycemia and severe hypoglycemia

    Time frame: 3 months

  3. Weight change

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Servier (Tianjin) Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

Phase 4 Study of Comparison of Combination Therapy of Gliclazide MR and Basal Insulin With Pre-mix Insulin Monotherapy for the Patients With Type 2 Diabetes Mellitus

Acronym: CODMS

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 18, 2008
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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