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| ID | Type | Description | Link |
|---|---|---|---|
| jRCTs051180211 | Registry Identifier | jRCT |
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| Name | Class |
|---|---|
| Sumitomo Pharma Co., Ltd. | INDUSTRY |
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Study subjects will be randomly assigned to the three groups and receive the study drug for maximum of 156 weeks and undergo blood samplings and other diabetes mellitus-related tests. The aim of the present study is to evaluate the durability of glycemic control over 3 years for patients with type 2 diabetes on diet and exercise therapy treated with oral hypoglycemic drug monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imeglimin | Experimental | Imeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily). |
|
| Metformin | Active Comparator | Metformin 500 mg orally twice daily in the morning and evening (1000 mg daily). However, until 2 weeks after the start of treatment, 250 mg should be administered orally twice daily in the morning and evening. Thereafter, after 4, 8, or 12 weeks, the dose may be increased up to 750 mg twice daily (1500 mg daily) if the physician determines that the hypoglycemic effect is inadequate. |
|
| Vildagliptin | Active Comparator | Vildagliptin 50 mg orally twice daily in the morning and evening (100 mg daily). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imeglimin | Drug | Imeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from study drug initiation (Week 0) to detection of two consecutive HbA1c levels of 7.0% or higher by laboratory tests after Week 16. | From 16 to 156 weeks after the start of study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time from Week 0 to addition of a type 2 diabetes mellitus medication after Week 16 | From 16 to 156 weeks after the start of study drug administration | |
| Time from detection of two consecutive HbA1c levels of 7.0% or higher to addition of a type 2 diabetes mellitus medication after Week 16. |
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Inclusion Criteria:
Exclusion Criteria:
When consent is obtained
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| Name | Affiliation | Role |
|---|---|---|
| Kohjiro Ueki, M.D., Ph.D. | Center Hospital of the National Center for Global Health and Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center Hospital of the National Center for Global Health and Medicine | Shinjuku-Ku | Tokyo | 162-8655 | Japan |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C575881 | imeglimin |
| D008687 | Metformin |
| D000077597 | Vildagliptin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D009570 |
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| Metformin | Drug | Metformin 500 mg orally twice daily in the morning and evening (1000 mg daily). However, until 2 weeks after the start of treatment, 250 mg should be administered orally twice daily in the morning and evening. Thereafter, after 4, 8, or 12 weeks, the dose may be increased up to 750 mg twice daily (1500 mg daily) if the physician determines that the hypoglycemic effect is inadequate. |
|
| Vildagliptin | Drug | Vildagliptin 50 mg orally twice daily in the morning and evening (100 mg daily). |
|
| From 16 to 156 weeks after the start of study drug administration |
| HbA1c level, fasting blood glucose level, and their changes from baseline at each measurement point | From 0 to 156 weeks after the start of study drug administration |
| Maximum decrease in HbA1c level during the observation period | From 0 to 156 weeks after the start of study drug administration |
| Proportion of patients achieving HbA1c level less than 7.0% at each measurement point | From 0 to 156 weeks after the start of study drug administration |
| Number of times of achieving HbA1c level less than 7.0% during the observation period | From 0 to 156 weeks after the start of study drug administration |
| Time from Week 0 to detection of two consecutive HbA1c levels of 7.0% or higher by laboratory tests after Week 16 by patient characteristics | From 0 to 156 weeks after the start of study drug administration |
| D004700 | Endocrine System Diseases |
| Nitriles |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |