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The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as combination therapy with biguanide or DPP-4 inhibitor in type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KAD-1229 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KAD-1229 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidences of Adverse Events | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at 52 Weeks | at week 0 and week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Japan | Kanto Region, Chugoku Region, Kyushu Region | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | KAD-1229 / DPP-4 Inhibitors | |
| FG001 | KAD-1229 / Biguanides |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One patient in the KAD-1229 / biguanides group was excluded because of early discontinuation and no evaluable HbA1c.
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| ID | Title | Description |
|---|---|---|
| BG000 | KAD-1229 / DPP-4 Inhibitors | |
| BG001 | KAD-1229 / Biguanides | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline in HbA1c at 52 Weeks | Posted | Mean | Standard Deviation | percentage of HbA1c | at week 0 and week 52 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KAD-1229 / DPP-4 Inhibitors |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Division | Kissei Pharmaceutical Co., Ltd | rinsyousiken@pharm.kissei.co.jp |
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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 |
|---|---|
| C087255 | mitiglinide |
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Total of all reporting groups
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| HbA1c | Mean | Standard Deviation | % |
|
|
| Primary | Incidences of Adverse Events | Posted | Number | Participants | 52 weeks |
|
|
|
| 1 |
| 67 |
| 34 |
| 67 |
| EG001 | KAD-1229 / Biguanides | 5 | 69 | 47 | 69 |
| prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| acute myocardial infarction | Cardiac disorders |
|
| traumatic lung injury | Respiratory, thoracic and mediastinal disorders |
|
| colonic polyp | Gastrointestinal disorders |
|
| brain contusion | Injury, poisoning and procedural complications |
|
| lumbar vertebral fracture | Injury, poisoning and procedural complications |
|
| rib fracture | Injury, poisoning and procedural complications |
|
| skull fracture | Injury, poisoning and procedural complications |
|
| Nasopharyngitis | Infections and infestations |
|
| Pharyngitis | Infections and infestations |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders |
|
| Dental caries | Gastrointestinal disorders |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Alanine aminotransferase increase | Investigations |
|
| γ-glutamyltransferase increase | Investigations |
|
| Blood urine present | Investigations |
|
| White blood cell count increase | Investigations |
|
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| D004700 | Endocrine System Diseases |