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DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy.
DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus (T2DM) on metformin monotherapy. This study will be a randomized, double-blind comparison of CJC-1134-PC versus placebo. Patients taking metformin will continue to take their metformin at the same dose for the duration of the study.
Patients with T2DM, who meet all the inclusion criteria and none of the exclusion criteria, will be randomly assigned to a treatment arm. All patients will undergo weekly clinic visits to receive 17 weeks of study treatment, including the titration period.
CJC-1134-PC or placebo treatment will be administered weekly by subcutaneous injection in the abdomen to patients in a fasting state. Patients will be closely monitored and evaluated for toxicity on an ongoing basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Weekly CJC-1134-PC | Experimental |
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| Arm 2 - Weekly CJC-1134-PC | Experimental |
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| Arm 3 - Weekly CJC-1134-PC | Experimental |
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| Arm 4 - Weekly CJC-1134-PC | Experimental |
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| Arm 5 - Weekly Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJC-1134-PC Injection | Drug | CJC-1134-PC administered weekly by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18 | CFB to Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Body Weight CFB to Week 18 | CFB to Week 18 | |
| Time to Hyperglycemia Rescue | 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Soon-Shiong, MD | Chief Executive Officer | Study Director |
| Robert Henry, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85018 | United States | ||
| Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 - Weekly CJC-1134-PC | CJC-1134-PC, 1.5 mg. weekly subcutaneous injection |
| FG001 | Arm 2 - Weekly CJC-1134-PC | CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Weekly placebo for CJC-1134-PC Injection | Drug | Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection |
|
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| Inglewood |
| California |
| 90301 |
| United States |
| Research Site | Tarzana | California | 91356 | United States |
| Research Site | Ventura | California | 93003 | United States |
| Research Site | Wellington | Florida | 33414 | United States |
| Research Site | Idaho Falls | Idaho | 83404 | United States |
| Research Site | Lexington | Kentucky | 40504 | United States |
| Research Site | Brighton | Massachusetts | 02135 | United States |
| Research Site | Greensboro | North Carolina | 27405 | United States |
| Research Site | Eugene | Oregon | 97401 | United States |
| Research Site | Altoona | Pennsylvania | 16602 | United States |
| Research Site | East Providence | Rhode Island | 02915 | United States |
| Research Site | Charleston | South Carolina | 29407 | United States |
| Research Site | Taylors | South Carolina | 29687 | United States |
| Research Site | Austin | Texas | 78758 | United States |
| Research Site | Dallas | Texas | 75231 | United States |
| Research Site | San Antonio | Texas | 78249 | United States |
| Research Site | Salt Lake City | Utah | 84107 | United States |
| Research Site | Henrico | Virginia | 23233 | United States |
| Research Site | Vancouver | British Columbia | Canada |
| Research Site | Smiths Falls | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| FG002 | Arm 3 - Weekly CJC-1134-PC | CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection |
| FG003 | Arm 4 - Weekly CJC-1134-PC | CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection |
| FG004 | Arm 5 - Weekly Placebo | Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection |
| COMPLETED |
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| NOT COMPLETED |
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Intent to Treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 - Weekly CJC-1134-PC | CJC-1134-PC, 1.5 mg. weekly subcutaneous injection |
| BG001 | Arm 2 - Weekly CJC-1134-PC | CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection |
| BG002 | Arm 3 - Weekly CJC-1134-PC | CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection |
| BG003 | Arm 4 - Weekly CJC-1134-PC | CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection |
| BG004 | Arm 5 - Weekly Placebo | Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| 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 | Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18 | Completed Population | Posted | Mean | Standard Deviation | Percent (%) | CFB to Week 18 |
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| Secondary | Fasting Body Weight CFB to Week 18 | Completed Population | Posted | Mean | Standard Deviation | kg | CFB to Week 18 |
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| Secondary | Time to Hyperglycemia Rescue | Completed Population | Posted | Mean | Standard Deviation | days | 18 weeks |
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18 weeks
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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 | Arm 1 - Weekly CJC-1134-PC | CJC-1134-PC, 1.5 mg. weekly subcutaneous injection | 0 | 12 | 0 | 12 | 3 | 12 |
| EG001 | Arm 2 - Weekly CJC-1134-PC | CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection | 0 | 15 | 0 | 15 | 11 | 15 |
| EG002 | Arm 3 - Weekly CJC-1134-PC | CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection | 0 | 13 | 0 | 13 | 8 | 13 |
| EG003 | Arm 4 - Weekly CJC-1134-PC | CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection | 0 | 13 | 0 | 13 | 8 | 13 |
| EG004 | Arm 5 - Weekly Placebo | Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection | 0 | 14 | 0 | 14 | 5 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Influenza like illness | General disorders | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director of Regulatory Affairs | ConjuChem Biotechnologies Inc. | 310-405-7549 | Aleece.Nolasco@nantbio.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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