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| Name | Class |
|---|---|
| Kyorin Pharmaceutical Co.,Ltd | INDUSTRY |
To assess the safety and efficacy of chronic therapy with KRP-104, a novel DPP-IV inhibitor, in patients with Type 2 Diabetes on stable metformin therapy. In addition, an estimate of how much of the HbA1c response is attributable to nocturnal coverage will be explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KRP-104 120 mg QD | Experimental |
| |
| KRP-104 60 mg BID | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KRP-104 QD Drug: Placebo Drug: Metformin | Drug | KRP-104 120 mg: KRP-104 two 50 mg tablets and two 10 mg tablets 15 to 30 minutes before morning meal and 2 placebo tablets 15 to 30 minutes before evening meal |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this trial is to demonstrate the hemoglobin A1c (HbA1c)-lowering effects of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone. | 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the fasting plasma glucose (FPG)-lowering effect of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone; | 12-weeks | |
| To compare effects of once daily (QD) dosing versus twice daily (BID) dosing of KRP-104 on HbA1c and FPG |
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Inclusion Criteria:
Exclusion Criteria:
History of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia;
History or presence of alcoholism or drug abuse
Typical consumption of ≥10 drinks of alcohol weekly;
Presence of any of the following conditions:
Uncontrolled high blood pressure;
History or evidence of cardiovascular or pulmonary disease
Must meet other laboratory and Medical History clinical criteria. Please contact recruitment center for referrals
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| Name | Affiliation | Role |
|---|---|---|
| David Orloff | Medpace, Inc. | Study Chair |
| Tufail Syed | Medpace India | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego | California | United States |
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| Placebo Drug: Metformin | Drug | Two tablets 15 to 30 minutes before each meal, morning and evening. |
|
| KRP-104 BID Drug: Placebo Drug: Metformin | Drug | KRP-104 60 mg: KRP-104 one 50 mg tablet plus one 10 mg tablet 15 to 30 minutes before each meal, morning and evening. |
|
| 12 weeks |
| To assess the effects of KRP-104 on post-prandial glucose dynamics and insulin sensitivity (homeostasis model index [HOMA-β]) in the setting of a Meal Tolerance Test(MTT) | Changes from pre-prandial to 2-hour post-prandial glucose, active GLP-1, insulin summarized by treatment group from Week 0 to Week 5 and Week 12. Percent change in 2-hour post-prandial glucose summarized by treatment group from Week 0 to Week 5 and Week 12. | 12 weeks |
| To assess the safety and tolerability of KRP-104; | Daily for 12 weeks to 2 weeks post-treatment |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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