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
This study will evaluate the effect of dose escalation of once-weekly (QW) subcutaneous (SC) OPK-8003 injections vs placebo on HbA1c absolute change from baseline at 30 weeks in subjects with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin.
This clinical trial is a phase 2, double-blind dose escalation regimen of once-weekly OPK-88003 in subjects with T2DM. The trial consists of a screening/baseline (up to 2 weeks prior to first dose), treatment period consisting of a dose escalation (8 weeks) and a target dose (22 weeks), and a follow-up period (4 weeks). Subjects will be randomly assigned to volume-matched OPK-88003 or placebo administered QW.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate |
|
| OPK-88003 | Experimental | 70 mg/vial (extractable volume 1 mL) (20mg for 4 weeks, 40 mg for 4 weeks and 70 mg for 22 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPK-88003 | Drug | OPK-88003 subcutaneous injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c in Subjects With Type 2 DM | To evaluate the effect of dose escalation of QW SC OPK-88003 vs placebo injections on HbA1c absolute change from baseline to after 30 weeks treatment in subjects with T2DM inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin. | From baseline to 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent (%) Body Weight Change | Mean percent (%) body weight change from baseline to after 30 weeks treatment | From baseline to 30 weeks |
| Percent (%) of Subjects With 5% or Greater Body Weight Loss. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Militza Vera De Alba, MD | OPKO Health, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Research Institute - Huntington Park | Huntington Park | California | 90255 | United States | ||
| National Research Institute - Wilshire |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate Placebo: Placebo subcutaneous injection |
| FG001 | OPK-88003 | 70 mg/vial (extractable volume 1 mL) OPK-88003: OPK-88003 subcutaneous injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate Placebo: Placebo subcutaneous injection |
| BG001 | OPK-88003 | 70 mg/vial (extractable volume 1 mL) OPK-88003: OPK-88003 subcutaneous injection |
| 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 in HbA1c in Subjects With Type 2 DM | To evaluate the effect of dose escalation of QW SC OPK-88003 vs placebo injections on HbA1c absolute change from baseline to after 30 weeks treatment in subjects with T2DM inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin. | Posted | Least Squares Mean | Standard Error | mmols/mol | From baseline to 30 weeks |
|
36 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 | Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate Placebo: Placebo subcutaneous injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Branch retinal artery occlusion | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| OPKO Health Inc | OPKO Health Inc | 3055754100 | contact@opko.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 9, 2018 | Apr 20, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 4, 2019 | Apr 20, 2021 | SAP_001.pdf |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo subcutaneous injection |
|
Percent (%) of subjects with 5% or greater body weight loss after 30 weeks treatment
| 30 weeks. |
| Change From Baseline of Fasting Plasma Glucose (FPG). | Change of FPG from baseline to after 30 weeks treatment | 30 weeks. |
| Los Angeles |
| California |
| 90057 |
| United States |
| Clinical Pharmacology of Miami, LLC | Hialeah | Florida | 33014 | United States |
| BG002 | Total | Total of all reporting groups |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Mean Percent (%) Body Weight Change | Mean percent (%) body weight change from baseline to after 30 weeks treatment | Posted | Least Squares Mean | Standard Error | Percentage of body weight change | From baseline to 30 weeks |
|
|
|
| Secondary | Percent (%) of Subjects With 5% or Greater Body Weight Loss. | Percent (%) of subjects with 5% or greater body weight loss after 30 weeks treatment | Posted | Number | Percentage of participants | 30 weeks. |
|
|
|
| Secondary | Change From Baseline of Fasting Plasma Glucose (FPG). | Change of FPG from baseline to after 30 weeks treatment | Posted | Least Squares Mean | Standard Error | mg/dL | 30 weeks. |
|
|
|
| 0 |
| 41 |
| 2 |
| 41 |
| 5 |
| 41 |
| EG001 | OPK-88003 | 70 mg/vial (extractable volume 1 mL) OPK-88003: OPK-88003 subcutaneous injection | 0 | 72 | 9 | 72 | 35 | 72 |
| Branch retinal artery occlusion account for peripheral vision loss right eye | Eye disorders | Systematic Assessment |
|
| Acute cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
|
| Acute pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
|
| Hypersensitivity reaction | Immune system disorders | Systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | Systematic Assessment |
|
| Renal calculi | Renal and urinary disorders | Systematic Assessment |
|
| Right fibula fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Right distal tibia fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Small bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Non st-segment elevation myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Acute diverticulitis | Infections and infestations | Systematic Assessment |
|
| Cecal volvulus s/p right hemicolectomy | Gastrointestinal disorders | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Acute toxic encephalopathy | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | Systematic Assessment |
|
| Lipase increased | Investigations | Systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |