Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy of KAD-1229 as combination therapy with insulin for 16 weeks and up to 52 weeks administration in patients with type 2 Diabetes Mellitus who show inadequate glycemic control with diet, and insulin monotherapy, or insulin and oral hypoglycemic agent.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KAD-1229/KAD-1229 | Experimental | Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study. |
|
| Placebo/KAD-1229 | Other | Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KAD-1229 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c | 16 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Japan |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/KAD-1229 | Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study. KAD-1229 Placebo Insulin |
| FG001 | KAD-1229/KAD-1229 | Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study. KAD-1229 Insulin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind Period |
|
| |||||||||||||||||||||
| Open-label Period |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/KAD-1229 | Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study. KAD-1229 Placebo Insulin |
| BG001 | KAD-1229/KAD-1229 |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in HbA1c | full analysis set | Posted | Mean | Standard Deviation | % (value of HbA1c) | 16 weeks |
|
Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo/KAD-1229 (Data Through Week 16) | Show the adverse events which occurred with placebo administration during the double-blind period |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold sweat | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Corrected as hypoglycaemia |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Division | Kissei Pharmaceutical Co., Ltd | Email only | rinsyousiken@pharm.kissei.co.jp |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C087255 | mitiglinide |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
|
| Insulin | Drug |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
|
Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study. KAD-1229 Insulin |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| HbA1c | Mean | Standard Deviation | % |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 60 |
| 2 |
| 60 |
| 19 |
| 60 |
| EG001 | KAD-1229/KAD-1229 (Data Through Week 16) | Show the adverse events which occurred with KAD-1229 administration during the double-blind period | 0 | 118 | 4 | 118 | 28 | 118 |
| EG002 | KAD-1229 (Data Through Week 52) | KDT-1229 administration period in all patients | 0 | 175 | 18 | 175 | 98 | 175 |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Thrombotic cerebral infarction | Nervous system disorders | Non-systematic Assessment |
|
| Cataract | Eye disorders | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | Non-systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | Non-systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | Non-systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | Non-systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | Non-systematic Assessment |
|
|
| Hunger | General disorders | Non-systematic Assessment | Corrected as hypoglycaemia |
|
| Asthenia | General disorders | Non-systematic Assessment | Corrected as hypoglycaemia |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment | Corrected as hypoglycaemia |
|
| Hypoglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment | Corrected as hypoglycaemia |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | Non-systematic Assessment | Corrected as hypoglycaemia |
|
| Periodontitis | Infections and infestations | Non-systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |