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This is a randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety, and pharmacodynamics (PD) of multiple doses of REMD-477 in subjects who have Type 1 diabetes and are currently receiving insulin treatment. This study will determine whether REMD-477 can decrease daily insulin requirements and improve glycemic control after 12 weeks of treatment in subjects diagnosed with Type 1 diabetes with fasting C-peptide < 0.7 ng/mL at Screening.
The study will be conducted at multiple sites in the United States. Approximately 150 subjects with type 1 diabetes on stable doses of insulin will be randomized in a 1:1:1 fashion into one of three treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 35 mg REMD-477 | Experimental | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes |
|
| 70 mg REMD-477 | Experimental | Administered as a repeated SC doses in subjects with Type 1 Diabetes |
|
| Matching placebo | Placebo Comparator | Administered as a repeated SC doses in subjects with Type 1 Diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REMD-477 | Biological | Administered as repeated SC doses in subjects with Type 1 Diabetes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Daily Total Insulin Use | Change from Baseline in average daily total insulin use at Week 12 | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Difference in AUC Glucose Concentrations Following Mixed Meal Tolerance Test (MMTT) - Part A Only | Difference from baseline at Week 13 in AUC glucose concentration following the Mixed Meal Tolerance Test (MMTT) after repeated doses of REMD-477. | Baseline and 13 weeks; AUC glucose timepoints: 10 minutes prior and just before (time ) initiating the mixed-meal ingestion and at 30, 60 and 120 minutes after the mixed meal ingestion. |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute | Escondido | California | 92025 | United States | ||
| Marin Endocrine Care & Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39146397 | Derived | Santiago Padilla L, Schiattarella GG. Targeting HFpEF: Unlocking the Potential of Glucagon Receptor Blockade. Circ Res. 2024 Aug 16;135(5):629-631. doi: 10.1161/CIRCRESAHA.124.325130. Epub 2024 Aug 15. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A - 35 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 35 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| FG001 | Part A - 70 mg REMD-477 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 26, 2018 | Dec 8, 2022 |
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| Placebo Comparator | Biological | Administered as a repeated SC doses in subjects with Type 1 Diabetes |
|
| Continuous Glucose Monitoring (CGM) - Change in Average Daily 24-hour Glucose Concentration at Week 12 | Change from baseline at Week 12 in average daily 24-h blood glucose as assessed by CGM after repeated doses of REMD-477. | Baseline and 12 weeks |
| Seven-Point Glucose Profile - Change in Average 24-h Glucose Concentrations | Change from baseline at Week 12 in the average daily 24-h blood glucose concentration as assessed by seven-point glucose profile after repeated doses of REMD-477. The 7-point blood glucose profiles includes measuring glucose via finger stick, at the following times of the day: before each meal, 2 hours after each meal, and at bedtime. The 7-point glucose profiles were obtained for 3 consecutive days before (Day 1) and for 3 consecutive days during week 12. | Baseline and 12 weeks |
| Summary of the Product of Average Daily 24-h Glucose Ratio and Daily Insulin Use Ratio (Day 78 [Week 12]/Baseline) | The product of the ratio of average glucose (Week 12/Baseline) and ratio of average insulin use (Week 12/Baseline). | Baseline and week 12 |
| Change in Hemoglobin A1c From Baseline at Week 13 | Change in Hemoglobin A1c from baseline at Week 13, after repeated doses of REMD-477. | Baseline and 13 weeks |
| Percentage of Subjects With HbA1c Reduction of ≥ 0.4% at Week 13 | Proportion (percentage) of subjects who achieve HbA1c reduction of ≥ 0.4%, after repeated doses of REMD-477 | Baseline and 13 weeks |
| Change in C-peptide Adjusted AUC Following Mixed Meal Tolerance Test (MMTT) | Change from baseline at Week 13 in the C-peptide adjusted AUC following MMTT after repeated doses of REMD-477. | Baseline and 13 weeks; AUC C-peptide timepoints: 10 minutes prior and just before (time 0) initiating the mixed-meal ingestion and at 30, 60 and 120 minutes after the mixed meal ingestion. |
| Change in Baseline Difference in Glucagon Adjusted AUC Following Mixed Meal Tolerance Test (MMTT) - Part A Only | Change from baseline at Week 13 in glucagon adjusted AUC after MMTT challenge, after repeated doses of REMD-477. | Baseline and 13 weeks; AUC glucagon timepoints: 10 minutes prior and just before (time ) initiating the mixed-meal ingestion and at 30, 60 and 120 minutes after the mixed meal ingestion. |
| Proportion of Subjects With Positive Anti-REMD-477 Antibodies | Proportion of subjects positive for anti-REMD-477 antibody formation. | Day 1 (pre-dose), Day 85 (Week 13) and Day 162 (Week 24) |
| Summary of REMD-477 Plasma Concentrations | REMD-477 serum-concentration after repeated doses of REMD-477. | Baseline (Day 1 pre-dose) and Weeks 2, 5, 9, 13 and 16. |
| Change in Hemoglobin A1c at Week 13 in Subjects With Baseline HbA1c ≥7.5% | Change in Hemoglobin A1c from baseline at Week 13, after repeated doses of REMD-477. | Baseline and 13 weeks |
| Proportion of Subjects With Targeted Hemoglobin A1C (HbA1c) of ≤ 7.0% at Week 13 | Proportion (percentage) of subjects who achieve target HbA1c reduction of ≤ 7.0% at Week 13, after repeated doses of REMD-477 | Baseline and 13 weeks |
| Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Target Blood Glucose Range (70-180 mg/dL) at Week 12 | Change from baseline at Week 12 in percent time spent in target blood glucose range (70-180 mg/dL) after repeated doses of REMD-477. | Baseline and 12 weeks |
| Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hyperglycemia (Blood Glucose Range >180 mg/dL) at Week 12 | Change from baseline at Week 12 in percent time spent in Hyperglycemia (Blood Glucose Range >180 mg/dL) after repeated doses of REMD-477. | Baseline and 12 weeks |
| Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hypoglycemia (Blood Glucose Range <70 mg/dL) at Week 12 | Change from baseline at Week 12 in percent time spent in Hypoglycemia (Blood Glucose Range <70 mg/dL) after repeated doses of REMD-477. | Baseline and 12 weeks |
| Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hypoglycemia (Blood Glucose Range <55 mg/dL) at Week 12 | Change from baseline at Week 12 in percent time spent in Hypoglycemia (Blood Glucose Range <55 mg/dL) after repeated doses of REMD-477. | Baseline and 12 weeks |
| Greenbrae |
| California |
| 94904 |
| United States |
| Altman Clinical and Translational Research Institute | San Diego | California | 92037 | United States |
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States |
| University of Colorado, Denver/Barbara Davis Center for Diabetes | Aurora | Colorado | 80045 | United States |
| Atlanta Diabetes Assoicates | Atlanta | Georgia | 30318 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Texas Diabetes & Endocrinology | Austin | Texas | 78749 | United States |
| Dallas Diabetes Research Center | Dallas | Texas | 75230 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
| Rainer Clinical Research Center | Renton | Washington | 98057 | United States |
Administered as a repeated SC doses in subjects with Type 1 Diabetes
70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes
| FG002 | Part A - Matching Placebo | Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes |
| FG003 | Part B - 35 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 35 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| FG004 | Part B - 70 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| FG005 | Part B - Matching Placebo | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A - 35 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 35 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| BG001 | Part A - 70 mg REMD-477 | Administered as a repeated SC doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| BG002 | Part A - Matching Placebo | Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes |
| BG003 | Part B - 35 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 35 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| BG004 | Part B - 70 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| BG005 | Part B - Matching Placebo | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Baseline Average HbA1c Values | Least Squares Mean | Standard Deviation | Percentage |
| |||||||||||||||
| Baseline Average Daily Total Insulin Use Values | Least Squares Mean | Standard Deviation | Units/day |
| |||||||||||||||
| Time Since Type 1 Diabetes Diagnosis | Mean | Standard Deviation | years |
|
| 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 Average Daily Total Insulin Use | Change from Baseline in average daily total insulin use at Week 12 | Posted | Least Squares Mean | Standard Error | Units/day | Baseline and 12 weeks |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline Difference in AUC Glucose Concentrations Following Mixed Meal Tolerance Test (MMTT) - Part A Only | Difference from baseline at Week 13 in AUC glucose concentration following the Mixed Meal Tolerance Test (MMTT) after repeated doses of REMD-477. | Posted | Least Squares Mean | Standard Error | min*mg/dL | Baseline and 13 weeks; AUC glucose timepoints: 10 minutes prior and just before (time ) initiating the mixed-meal ingestion and at 30, 60 and 120 minutes after the mixed meal ingestion. |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Continuous Glucose Monitoring (CGM) - Change in Average Daily 24-hour Glucose Concentration at Week 12 | Change from baseline at Week 12 in average daily 24-h blood glucose as assessed by CGM after repeated doses of REMD-477. | Posted | Least Squares Mean | Standard Error | mg/dL/day | Baseline and 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Seven-Point Glucose Profile - Change in Average 24-h Glucose Concentrations | Change from baseline at Week 12 in the average daily 24-h blood glucose concentration as assessed by seven-point glucose profile after repeated doses of REMD-477. The 7-point blood glucose profiles includes measuring glucose via finger stick, at the following times of the day: before each meal, 2 hours after each meal, and at bedtime. The 7-point glucose profiles were obtained for 3 consecutive days before (Day 1) and for 3 consecutive days during week 12. | Part A patients' compliance with the recordings of glucose values on paper diary were low, and greater than 50% of the data was missing. | Posted | Least Squares Mean | Standard Error | mg/dL/day | Baseline and 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Summary of the Product of Average Daily 24-h Glucose Ratio and Daily Insulin Use Ratio (Day 78 [Week 12]/Baseline) | The product of the ratio of average glucose (Week 12/Baseline) and ratio of average insulin use (Week 12/Baseline). | Posted | Least Squares Mean | Standard Error | Ratio | Baseline and week 12 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Hemoglobin A1c From Baseline at Week 13 | Change in Hemoglobin A1c from baseline at Week 13, after repeated doses of REMD-477. | Posted | Least Squares Mean | Standard Error | Percentage | Baseline and 13 weeks |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With HbA1c Reduction of ≥ 0.4% at Week 13 | Proportion (percentage) of subjects who achieve HbA1c reduction of ≥ 0.4%, after repeated doses of REMD-477 | Posted | Count of Participants | Participants | Baseline and 13 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in C-peptide Adjusted AUC Following Mixed Meal Tolerance Test (MMTT) | Change from baseline at Week 13 in the C-peptide adjusted AUC following MMTT after repeated doses of REMD-477. | MMTT was completed in Part A subjects only. MMTT was removed from Part B as part of a protocol amendment, and Part B subjects did not complete the MMTT. | Posted | Least Squares Mean | Standard Error | min*pmol/L | Baseline and 13 weeks; AUC C-peptide timepoints: 10 minutes prior and just before (time 0) initiating the mixed-meal ingestion and at 30, 60 and 120 minutes after the mixed meal ingestion. |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Baseline Difference in Glucagon Adjusted AUC Following Mixed Meal Tolerance Test (MMTT) - Part A Only | Change from baseline at Week 13 in glucagon adjusted AUC after MMTT challenge, after repeated doses of REMD-477. | MMTT was completed in Part A subjects only. Part B subjects did not complete the MMTT. | Posted | Least Squares Mean | Standard Error | min*pmol/L | Baseline and 13 weeks; AUC glucagon timepoints: 10 minutes prior and just before (time ) initiating the mixed-meal ingestion and at 30, 60 and 120 minutes after the mixed meal ingestion. |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Positive Anti-REMD-477 Antibodies | Proportion of subjects positive for anti-REMD-477 antibody formation. | Posted | Number | participants | Day 1 (pre-dose), Day 85 (Week 13) and Day 162 (Week 24) |
|
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Summary of REMD-477 Plasma Concentrations | REMD-477 serum-concentration after repeated doses of REMD-477. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Baseline (Day 1 pre-dose) and Weeks 2, 5, 9, 13 and 16. |
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| Secondary | Change in Hemoglobin A1c at Week 13 in Subjects With Baseline HbA1c ≥7.5% | Change in Hemoglobin A1c from baseline at Week 13, after repeated doses of REMD-477. | Posted | Least Squares Mean | Standard Error | Percentage | Baseline and 13 weeks |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Targeted Hemoglobin A1C (HbA1c) of ≤ 7.0% at Week 13 | Proportion (percentage) of subjects who achieve target HbA1c reduction of ≤ 7.0% at Week 13, after repeated doses of REMD-477 | Posted | Count of Participants | Participants | Baseline and 13 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Target Blood Glucose Range (70-180 mg/dL) at Week 12 | Change from baseline at Week 12 in percent time spent in target blood glucose range (70-180 mg/dL) after repeated doses of REMD-477. | Posted | Least Squares Mean | Standard Error | Percentage of time spent in range | Baseline and 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hyperglycemia (Blood Glucose Range >180 mg/dL) at Week 12 | Change from baseline at Week 12 in percent time spent in Hyperglycemia (Blood Glucose Range >180 mg/dL) after repeated doses of REMD-477. | Posted | Least Squares Mean | Standard Error | Percentage of time spent in range | Baseline and 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hypoglycemia (Blood Glucose Range <70 mg/dL) at Week 12 | Change from baseline at Week 12 in percent time spent in Hypoglycemia (Blood Glucose Range <70 mg/dL) after repeated doses of REMD-477. | Posted | Least Squares Mean | Standard Error | Percentage of time spent in range | Baseline and 12 weeks |
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| Secondary | Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hypoglycemia (Blood Glucose Range <55 mg/dL) at Week 12 | Change from baseline at Week 12 in percent time spent in Hypoglycemia (Blood Glucose Range <55 mg/dL) after repeated doses of REMD-477. | Posted | Least Squares Mean | Standard Error | Percentage of time spent in range | Baseline and 12 weeks |
|
All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).
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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 | Part A - 35 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes | 0 | 25 | 0 | 25 | 20 | 25 |
| EG001 | Part A - 70 mg REMD-477 | Administered as a repeated SC doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes | 0 | 25 | 0 | 25 | 18 | 25 |
| EG002 | Part A - Matching Placebo | Administered as a repeated SC doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes | 0 | 25 | 2 | 25 | 20 | 25 |
| EG003 | Part B - 35 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes | 0 | 26 | 1 | 26 | 14 | 26 |
| EG004 | Part B - 70 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes | 0 | 26 | 1 | 26 | 18 | 26 |
| EG005 | Part B - Matching Placebo | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes | 0 | 27 | 2 | 27 | 9 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferace increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Alanine aminotransferace increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dung "Zung" Thai, MD, PhD | REMD Biotherapeutics, Inc | 415-225-9338 | zungthai@remdbio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 12, 2019 | Dec 8, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000629677 | volagidemab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG004 | Part B - 70 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| OG005 | Part B - Matching Placebo | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes |
|
|
Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes
Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes
| OG003 | Part B - 35 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 35 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| OG004 | Part B - 70 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| OG005 | Part B - Matching Placebo | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes |
|
|
| OG004 | Part B - 70 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| OG005 | Part B - Matching Placebo | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes |
|
|
| OG004 | Part B - 70 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| OG005 | Part B - Matching Placebo | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes |
|
|
| OG004 | Part B - 70 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| OG005 | Part B - Matching Placebo | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes |
|
|
|
|
|
|
|
|
|
|
| OG004 | Part B - 70 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| OG005 | Part B - Matching Placebo | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes |
|
|
| OG004 | Part B - 70 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| OG005 | Part B - Matching Placebo | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes |
|
|
| OG004 | Part B - 70 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| OG005 | Part B - Matching Placebo | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes |
|
|
Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes
35 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes
| OG004 | Part B - 70 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| OG005 | Part B - Matching Placebo | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes |
|
|
Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes
35 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes
| OG004 | Part B - 70 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| OG005 | Part B - Matching Placebo | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes |
|
|
Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes
35 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes
| OG004 | Part B - 70 mg REMD-477 | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes 70 mg REMD-477: Administered as repeated SC doses in subjects with Type 1 Diabetes |
| OG005 | Part B - Matching Placebo | Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Placebo Comparator: Administered as a repeated SC doses in subjects with Type 1 Diabetes |
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