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| Name | Class |
|---|---|
| Mediscience Planning, Inc. | INDUSTRY |
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The objectives of the study is to evaluate the efficacy and safety of DS-8500a compared with placebo in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin.
In patients with type 2 diabetes mellitus being treated with sitagliptin, efficacy and safety of DS-8500a are to be evaluated after 28-day multiple oral administration of DS-8500a at 25 or 75 mg, in a double-blind, placebo-controlled, parallel-group comparison study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DS-8500a 25 mg QD | Experimental | DS-8500a 25 mg tablets, orally, once daily (QD) for up to 28 days |
|
| DS-8500a 75 mg QD | Experimental | DS-8500a 75 mg tablets, orally, once daily (QD) for up to 28 days |
|
| placebo | Placebo Comparator | placebo tablets, orally, once daily for up to 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-8500a 25 mg | Drug |
| ||
| DS-8500a 75 mg |
| Measure | Description | Time Frame |
|---|---|---|
| change in 24 hour weighted mean glucose | baseline (Day -1) to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| change in fasting plasma glucose | baseline (Day -1) to Day 28 | |
| change in plasma glucose | Day -1 and Day 28: Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast; 0.5, 1, 2, and 4 hours after starting lunch before evening meal; 0.5, 1, 2, and 4 hours after starting evening meal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yasuo Terauchi, MD, PhD | Yokohama City University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yodogawaku | Osaka | 565-0853 | Japan |
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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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 |
|---|---|
| C000629701 | firuglipel |
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| placebo | Drug |
|
| baseline (Day -1) and Day 28 |
| change in glycoalbumin | baseline (Day -1) and Day 28 |
| change in serum insulin | Day -1 and Day 28: Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast; 0.5, 1, 2, and 4 hours after starting lunch before evening meal; 0.5, 1, 2, and 4 hours after starting evening meal | baseline (Day -1) and Day 28 |
| change in proinsulin | baseline (Day -1) and Day 28 |
| change in C-peptide | Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast | baseline (Day -1) and Day 28 |
| change in PYY (pancreatic peptide YY3-36) | Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast | baseline (Day -1) and Day 28 |
| change in total GLP-1 (Glucagon-like peptide-1) | baseline (Day -1) and Day 28 |
| change in active GLP-1 (Glucagon-like peptide-1) | Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast | baseline (Day -1) and Day 28 |
| change in total GIP (Gastric inhibitory polypeptide) | Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast | baseline (Day -1) and Day 28 |
| change in total glucagon | Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast | baseline (Day -1) and Day 28 |
| change in total total cholesterol | baseline (Day -1) to after dosing on Day 28 |
| change in total HDL (high density lipoprotein) cholesterol | baseline (Day -1) to after dosing on Day 28 |
| change in total LDL (low density lipoprotein) cholesterol | baseline (Day -1) to after dosing on Day 28 |
| change in total triglyceride | baseline (Day -1) to after dosing on Day 28 |
| number and severity of adverse events | baseline (Day -1) to after dosing on Day 28 |
| change in derived plasma glucose AUC | change in pharmacodynamic parameters derived from plasma glucose; AUC0-24h, AUC 0-4h, AUC4-8h, AUC9-13h | baseline (Day -1) to after dosing on Day 28 |
| change in derived serum insulin AUC | change in pharmacodynamic parameters derived from serum insulin; AUC0-24h, AUC 0-4h, AUC4-8h, AUC9-13h | baseline (Day -1) to after dosing on Day 28 |
| change in derived C-peptide AUC | change in pharmacodynamic parameters derived from C-peptide; AUC0-4h | baseline (Day -1) to after dosing on Day 28 |
| change in derived PYY AUC | change in pharmacodynamic parameters derived from PYY; AUC0-4h | baseline (Day -1) to after dosing on Day 28 |
| change in derived total GLP-1 AUC | change in pharmacodynamic parameters derived from total GLP-1; AUC0-4h | baseline (Day -1) to after dosing on Day 28 |
| change in derived active GLP-1 AUC | change in pharmacodynamic parameters derived from active GLP-1; AUC0-4h | baseline (Day -1) to after dosing on Day 28 |
| change in derived total GIP AUC | change in pharmacodynamic parameters derived from total GIP; AUC0-4h | baseline (Day -1) to after dosing on Day 28 |
| change in derived glucagon AUC | change in pharmacodynamic parameters derived from glucagon; AUC0-4h | baseline (Day -1) to after dosing on Day 28 |
| D004700 | Endocrine System Diseases |