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Study of Combination Therapy of Gliclazide MR and Basal Insulin Versus Insulin Monotherapy to Treat Type 2 Diabetes (CODMS)
Servier Protocol Code:
IC4-5702-205-CHN
Sponsor:
Servier (Tianjin) Pharmaceutical Co. LTD.
Clinicaltrials.gov Identifier:
NCT00736515
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How to participate in this study
If you think you are eligible for this study (see
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
eligibility criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
The study has 8 locations
Study 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%
Official 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
Conditions
Type 2 Diabetes
Interventions / Treatments
The treatment(s) given to the participants in the study.
- Gliclazide MR and Insulin Glargine Injection
- Biosynthetic Human Insulin Injection
Other study id numbers
Other identification numbers the study may be known by.
- IC4-5702-205-CHN
Eligibility Criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligible age for the study
35 years to 65 years
(Adult, Older Adult)
Sex
Male/FemaleAccepts Healthy Volunteers
No- 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
- 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
How is the study designed?
Allocation
How participants are assigned to different groups. Allocation can be random (randomized) or predetermined (non-randomized). Randomized means that participants are assigned at random to their participant group / arm.
Interventional study model
How treatments are given and tested in a study.
Parallel
A parallel study design compares two or more groups at the same time, with each group receiving a different treatment. Researchers then compare the results to determine which treatment is more effective.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
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
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
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
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Active Comparator:
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.
Intervention / Treatment
The treatment(s) given to the participants in the study.
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
Keywords
Provided by Servier
combination therapy,monotherapy,gliclazide MR,insulin,CGMS
Additional Relevant MeSH Terms Glioma
Diabetes Mellitus, Type 2