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This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study.
The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with CJC-1134-PC in patients with type 2 diabetes mellitus who are currently on metformin monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 12 weekly doses of 1.5 mg CJC-1134-PC |
|
| 2 | Experimental | 4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC |
|
| 3 | Placebo Comparator | 12 weekly doses of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJC-1134-PC | Drug | 1.5 or 2.0 mg CJC-1134-PC |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of HbA1c From Baseline | Change from Baseline | Screening and Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in FPG From Baseline | Change from Baseline | Screening and Day 85 |
| Reduction in Fasting Body Weight From Baseline | Change from Baseline |
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Major Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ConjuChem Biotechnologies Inc. | Montreal | Quebec | H2X 3Y8 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1.5 mg CJC-1134-PC | 12 weekly doses of 1.5 mg CJC-1134-PC CJC-1134-PC: 1.5 mg CJC-1134-PC |
| FG001 | 1.5 or 2.0 mg CJC-1134-PC | 4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC |
| FG002 | Placebo | 12 weekly doses of placebo Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | 1.5 mg CJC-1134-PC | 12 weekly doses of 1.5 mg CJC-1134-PC CJC-1134-PC: 1.5 mg CJC-1134-PC |
| BG001 | 1.5 or 2.0 mg CJC-1134-PC | 4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC |
| 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 | Reduction of HbA1c From Baseline | Change from Baseline | Modified Intent-to-Treat Population | Posted | Mean | Standard Deviation | Percent (%) | Screening and Day 85 |
|
16 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 | 1.5 mg CJC-1134-PC | 12 weekly doses of 1.5 mg CJC-1134-PC CJC-1134-PC: 1.5 mg CJC-1134-PC |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Most common AEs |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director of Regulatory Affairs | ConjuChem Biotechnologies Inc. | 310-405-7549 | Aleece.Nolasco@nantbio.com |
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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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| Drug |
Placebo |
|
| Screening and Day 85 |
| BG002 | Placebo | 12 weekly doses of placebo Placebo: Placebo |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
12 weekly doses of placebo Placebo: Placebo |
|
|
| Secondary | Reduction in FPG From Baseline | Change from Baseline | Modified Intent-to-Treat Population | Posted | Mean | Standard Deviation | mg/dL | Screening and Day 85 |
|
|
|
| Secondary | Reduction in Fasting Body Weight From Baseline | Change from Baseline | Modified Intent-to-Treat Population | Posted | Mean | Standard Deviation | kg | Screening and Day 85 |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 36 |
| 49 |
| EG001 | 1.5 or 2.0 mg CJC-1134-PC | 4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC | 0 | 49 | 0 | 49 | 30 | 49 |
| EG002 | Placebo | 12 weekly doses of placebo Placebo: Placebo | 0 | 57 | 0 | 57 | 34 | 57 |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Most common AEs |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment | Most common AEs |
|
| Injection site bruising | General disorders | Systematic Assessment | Most common AEs |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment | Most common AEs |
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| Urinary tract infection | Infections and infestations | Systematic Assessment | Most common AEs |
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| Contusion | Injury, poisoning and procedural complications | Systematic Assessment | Most common AEs |
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| Anorexia | Metabolism and nutrition disorders | Systematic Assessment | Most common AEs |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Most common AEs |
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| Headache | Nervous system disorders | Systematic Assessment | Most common AEs |
|
| Dizziness | Nervous system disorders | Systematic Assessment | Most common AEs |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Most common AEs |
|
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| D004700 | Endocrine System Diseases |