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AzTrials

Type 2 DiabetesPhase 4CODMSNCT00736515

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

A Phase 4 study testing Gliclazide MR and Insulin Glargine Injection and Biosynthetic Human Insulin Injection in people with Type 2 Diabetes, run by Servier (Tianjin) Pharmaceutical Co. LTD. at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 65 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Gliclazide MR and Insulin Glargine Injection and Biosynthetic Human Insulin Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
8 sitesChina
Study dates
Oct 2008to Aug 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

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

    Hangzhou, Zhejiang, 310016

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

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

    Shanghai, Shanghai Municipality, 200233

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

    Wuhan, Hubei, 430030

Other trials in China

About this study

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

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.

Read the 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
Being tested
Gliclazide MR and Insulin Glargine Injection, Biosynthetic Human Insulin Injection
Keywords
combination therapy,monotherapy,gliclazide MR,insulin,CGMS
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gliclazide MR and Insulin Glargine InjectionDrug

    Also called Brand Name: Diamicron MR and Lantus

    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

  • Biosynthetic Human Insulin InjectionDrug

    Also called Brand Name: Novolin 30R

    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

Study groups in NCT00736515
Study groupRoleWhat they receive
Combination therapyExperimentalThe 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
Receives: Drug: Gliclazide MR and Insulin Glargine Injection
monotherapyActive comparatorThe 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.
Receives: Drug: Biosynthetic Human Insulin Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 months

Secondary outcomes (3)

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

    Measured: 3 months

  2. Incidence of hypoglycemia and severe hypoglycemia

    Measured: 3 months

  3. Weight change

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00736515
Sponsor's protocol ID
IC4-5702-205-CHN
Acronym
CODMS
Status last verified
Mar 2020
First submitted
15 Aug 2008
Last updated
3 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 15677775

  • 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.

    PubMed 25952634

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gliclazide MR and Insulin Glargine Injection and Biosynthetic Human Insulin Injection in people with Type 2 Diabetes, run by Servier (Tianjin) Pharmaceutical Co. LTD. at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decreasing value of FPG and HbA1c, dosage of insulin and control rate of FPG (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00736515, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.

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