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The goal of this clinical trial is to evaluate the Efficacy and Safety of Chiglitazar Added to Patients with type 2 diabetes who do not respond well to metformin combined with insulin glargine. The main question it aims to answer are:
• T2DM patients still cannot effectively control their blood sugar with the combination of insulin and metformin. The combination of follow-up treatment and hypoglycemic drugs is worth exploring, and it is necessary to explore and confirm the combination of effective and safe drugs for insulin resistance on the basis of the above treatment plans.
Participants will be asked to receive either Chiglitazar or placebo in addition to metformin and insulin glargine 18 weeks.
Researchers will compare placebo groups to see if the effective effect and safety indicators of Chiglitazar for reducing insulin dosage, lowering blood sugar, regulating blood lipids.
T2DM patients using insulin combined with metformin dual therapy regimen, still can not have effective control of blood sugar, the combination of follow-up treatment and hypoglycemic drugs is worth exploring, and it is necessary to base on the above treatment plans to explore and confirm the treatment of effective and safe drugs for insulin resistance. This study investigated the efficacy and safety of metformin combined with insulin glargine in the treatment of type 2 diabetes mellitus (T2DM) in patients who still have poor hypoglycemic effect, plus Chiglitazar 48mg/ day for 18 weeks.
A total of 128 patients were expected to be included, and were randomly assigned 1:1 to the combination of metformin and insulin glargine combined with Chiglitazar sodium tablet 48mg/ day group. Metformin and insulin glargine combined with placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Metformin and insulin glargine combined with sitaglitat sodium tablets 48mg/ day group; |
|
| Placebo group | Placebo Comparator | Metformin and insulin glargine combined with placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiglitazar sodium | Drug | tablets 48mg/ day administered for 18 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1C | Changes in HbA1C from baseline | 18 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin | Changes in the daily dose of insulin from baseline | 6 weeks and 18 weeks of treatment |
| Triglyceride | Changes in the daily dose of triglyceride from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
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Metformin and insulin glargine combined with Chiglitazar sodium tablets 48mg/ day group;Metformin and insulin glargine combined with placebo group.
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| Chiglitazar placebo |
| Drug |
tablets 48mg/ day administered for 18 weeks |
|
| 18 weeks of treatment |
| Fasting blood glucose | Changes in the daily dose of fasting blood glucose from baseline | 6 weeks and 18 weeks of treatment |
| Fasting C-Peptide | Changes in the daily dose of fasting C-Peptide from baseline | 18 weeks of treatment |