Phase 2
N=154
Multiple Dose Study to Evaluate the Efficacy, Safety and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes Mellitus
Type1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT03117998 ↗Enrolled (actual)
154
Serious AEs
3.9%
Results posted
May 2023
Primary outcome: Primary: Change in Average Daily Total Insulin Use — -6.72; -5.25; -1.37; -7.59 Units/day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- REMD-477 (Biological); Placebo Comparator (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- REMD Biotherapeutics, Inc.
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Average Daily Total Insulin Use |
-6.72; -5.25; -1.37; -7.59; -6.64; -1.27 | — |
| SECONDARY Change From Baseline Difference in AUC Glucose Concentrations Following Mixed Meal Tolerance Test (MMTT) - Part A Only |
-150.68; -115.05; -66.00 | — |
| SECONDARY Continuous Glucose Monitoring (CGM) - Change in Average Daily 24-hour Glucose Concentration at Week 12 |
0.46; -5.71; 0.57; 2.57; -6.05; 6.08 | — |
| SECONDARY Seven-Point Glucose Profile - Change in Average 24-h Glucose Concentrations |
11.02; -9.43; -4.09; -4.52; -3.71; 5.07 | — |
| SECONDARY Summary of the Product of Average Daily 24-h Glucose Ratio and Daily Insulin Use Ratio (Day 78 [Week 12]/Baseline) |
0.86; 0.81; 0.98; 0.88; 0.89; 0.95 | — |
| SECONDARY Change in Hemoglobin A1c From Baseline at Week 13 |
-0.67; -0.66; -0.43; -0.64; -0.60; -0.11 | — |
| SECONDARY Percentage of Subjects With HbA1c Reduction of ≥ 0.4% at Week 13 |
16; 17; 9; 13; 12; 8 | — |
| SECONDARY Change in C-peptide Adjusted AUC Following Mixed Meal Tolerance Test (MMTT) |
27.33; 289.93; 166.99 | — |
| SECONDARY Change in Baseline Difference in Glucagon Adjusted AUC Following Mixed Meal Tolerance Test (MMTT) - Part A Only |
2398.76; 345.14; 13.40 | — |
| SECONDARY Proportion of Subjects With Positive Anti-REMD-477 Antibodies |
2; 4; 5; 1; 1; 4 | — |
| SECONDARY Summary of REMD-477 Plasma Concentrations |
0; 0; 0; 0; 1070; 3600 | — |
| SECONDARY Change in Hemoglobin A1c at Week 13 in Subjects With Baseline HbA1c ≥7.5% |
-1.02; -0.94; -0.70; -0.93; -0.54; -0.12 | — |
| SECONDARY Proportion of Subjects With Targeted Hemoglobin A1C (HbA1c) of ≤ 7.0% at Week 13 |
16; 19; 9; 12; 8; 4 | — |
| SECONDARY Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Target Blood Glucose Range (70-180 mg/dL) at Week 12 |
0.55; 7.38; 1.54; 1.13; 4.20; 1.19 | — |
| SECONDARY Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hyperglycemia (Blood Glucose Range >180 mg/dL) at Week 12 |
0.21; -7.99; -1.11; 1.74; -5.02; -0.65 | — |
| SECONDARY Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hypoglycemia (Blood Glucose Range <70 mg/dL) at Week 12 |
-0.82; 0.05; -0.03; -2.85; 0.85; -0.59 | — |
| SECONDARY Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hypoglycemia (Blood Glucose Range <55 mg/dL) at Week 12 |
-0.15; 0.27; -0.03; -1.31; .25; -0.67 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Men and women between the ages of 18 and 65 years old, inclusive, at the time of screening;
- Females of non-child bearing potential must be ≥1 year post-menopausal (confirmed by a serum follicle-stimulating hormone (FSH) levels ≥ 40 IU/mL) or documented as being surgically sterile. Females of child bearing potential must agree to use two methods of contraception;
- Male subjects must be willing to use clinically acceptable method of contraception during the entire study;
- Body mass index between 18.5 and 32 kg/m2, inclusive, at screening;
- Diagnosed with Type 1 diabetes, based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;
- HbA1c > 7% and 10 cigarettes/day, and/or is unwilling to abstain from smoking during admission periods;
- Known sensitivity to mammalian-derived drug preparations, recombinant protein-based drugs or to humanized or human antibodies;
- History of illicit drug use or alcohol abuse within the last 6 months or a positive drug urine test result at screening;
- History of pancreatitis, pancreatic neuroendocrine tumors or multiple endocrine neoplasia (MEN) or family history of MEN;
- History of pheochromocytoma, or family history of familial pheochromocytoma;
- Known or suspected susceptibility to infectious disease (e.g. taking immunosuppressive agents or has a documented inherited or acquired immunodeficiency);
- Known history of positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C antibodies (HepC Ab);
- Participation in an investigational drug or device trial within 30 days of screening or within 5 times the half-life of the investigational agent in the other clinical study, if known, whichever period is longer;
- Blood donor or blood loss > 500 mL within 30 days of Day 1;
- Women who are pregnant or lactating/breastfeeding;
- Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;
- Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent
Other inclusion and exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03117998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.