volagidemab (REMD-477) / Amgen, REMD Bio 
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  • ||||||||||  Inpefa (sotagliflozin) / Lexicon Pharma, volagidemab (REMD-477) / Amgen, REMD Bio
    Enrollment open, Trial completion date, Trial primary completion date:  SOTA: Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes (clinicaltrials.gov) -  Nov 4, 2024   
    P1/2,  N=24, Recruiting, 
    Combination therapy improves glycemic control, reduces insulin dosing, and suggests a strategy to unlock the benefits of SGLT2 inhibitors while mitigating the risk of diabetic ketoacidosis. Not yet recruiting --> Recruiting | Trial completion date: Jan 2026 --> Jan 2028 | Trial primary completion date: Jan 2026 --> Jan 2028
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio
    Trial completion, Enrollment change:  Effect of Novel Glucagon Receptor Antagonist REMD-477 on Glucose and Adipocyte Metabolism in T2DM (clinicaltrials.gov) -  Aug 9, 2024   
    P1,  N=4, Completed, 
    Not yet recruiting --> Recruiting | Trial completion date: Jan 2026 --> Jan 2028 | Trial primary completion date: Jan 2026 --> Jan 2028 Suspended --> Completed | N=24 --> 4
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio
    Enrollment closed:  Effects of GRA in Patients With Type 1 (clinicaltrials.gov) -  Jan 23, 2024   
    P2,  N=30, Active, not recruiting, 
    Recruiting --> Suspended Recruiting --> Active, not recruiting
  • ||||||||||  Tzield (teplizumab) / Provention Bio, volagidemab (REMD-477) / Amgen, REMD Bio
    Review, Journal:  Emerging Anti-Diabetic Drugs for Beta-Cell Protection in Type 1 Diabetes. (Pubmed Central) -  Jun 14, 2023   
    Specifically, we discuss several non-immunomodulators that may have more direct action on beta cells, such as verapamil (a voltage-dependent calcium channel blocker), gamma aminobutyric acid (GABA, a major neurotransmitter with effects on beta cells), tauroursodeoxycholic acid (TUDCA, an endoplasmic reticulum chaperone), and volagidemab (a glucagon receptor antagonist). These emerging anti-diabetic drugs are expected to provide promising results in both beta-cell restoration and in suppressing cytokine-derived inflammation.
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio, Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca
    ADA Presidents' Select Abstract: Combining an SGLT Inhibitor with a Glucagon Receptor Antagonist (GRA) in Subjects with Type 1 Diabetes (Room 5; [Board No. 267]) -  Apr 10, 2023 - Abstract #ADA2023ADA_1955;    
    Peak beta-hydroxybutyrate (BHB) concentrations during IWT were lower with SGLTi + GRA treatment (2.03 mmol/L) than with SGLTi alone (2.44 mmol/L; P = 0.04); there was no significant difference in peak BHB with either treatment vs Baseline (2.14 mmol/L).Treatment with SGLTi + GRA improved glycemic control, reduced insulin use, and mitigated ketosis during hypoinsulinemia. These data suggest that combination adjunctive therapy may be effective to address multiple metabolic abnormalities in T1D.
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio
    Trial completion date, Trial primary completion date:  Effect of Novel Glucagon Receptor Antagonist REMD-477 on Glucose and Adipocyte Metabolism in T2DM (clinicaltrials.gov) -  Jan 25, 2023   
    P1,  N=24, Recruiting, 
    These data suggest that combination adjunctive therapy may be effective to address multiple metabolic abnormalities in T1D. Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2023 --> Jun 2024
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio, Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca
    Trial completion:  Combination GRA and SGLT-2i Treatment in Type 1 Diabetes (clinicaltrials.gov) -  Jan 23, 2023   
    P1/2,  N=12, Completed, 
    Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2023 --> Jun 2024 Active, not recruiting --> Completed
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio
    Clinical, P2 data, Journal:  Glucagon receptor antagonist volagidemab in type 1 diabetes: a 12-week, randomized, double-blind, phase 2 trial. (Pubmed Central) -  Oct 15, 2022   
    No increase in hypoglycemia was observed with volagidemab therapy; however, increases in serum transaminases, low-density lipoprotein (LDL)-cholesterol and blood pressure were observed. Although the primary endpoint did not meet the prespecified significance level, we believe that the observed reduction in HbA1c and tolerable safety profile provide a rationale for further randomized studies to define the long-term efficacy and safety of volagidemab in patients with T1D.
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio, Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca
    Trial completion date:  Combination GRA and SGLT-2i Treatment in Type 1 Diabetes (clinicaltrials.gov) -  Sep 14, 2022   
    P1/2,  N=12, Active, not recruiting, 
    Although the primary endpoint did not meet the prespecified significance level, we believe that the observed reduction in HbA1c and tolerable safety profile provide a rationale for further randomized studies to define the long-term efficacy and safety of volagidemab in patients with T1D. Trial completion date: May 2022 --> Oct 2022
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio
    Trial completion:  Metabolic Pathways of GRA in Patients With Type 1 Diabetes (clinicaltrials.gov) -  Jul 15, 2022   
    P1/2,  N=4, Completed, 
    Trial completion date: May 2022 --> Oct 2022 Active, not recruiting --> Completed
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio
    Trial completion date:  Metabolic Pathways of GRA in Patients With Type 1 Diabetes (clinicaltrials.gov) -  Mar 31, 2022   
    P1/2,  N=4, Active, not recruiting, 
    Active, not recruiting --> Completed Trial completion date: Oct 2021 --> May 2022
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio, Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca
    Trial completion date:  Combination GRA and SGLT-2i Treatment in Type 1 Diabetes (clinicaltrials.gov) -  Mar 31, 2022   
    P1/2,  N=12, Active, not recruiting, 
    Trial completion date: Oct 2021 --> May 2022 Trial completion date: Jan 2022 --> May 2022
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio, Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca
    Enrollment closed:  Combination GRA and SGLT-2i Treatment in Type 1 Diabetes (clinicaltrials.gov) -  Nov 5, 2021   
    P1/2,  N=12, Active, not recruiting, 
    Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio
    Enrollment open, Trial initiation date:  Effects of GRA in Patients With Type 1 (clinicaltrials.gov) -  Sep 27, 2021   
    P2,  N=30, Recruiting, 
    Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | Initiation date: Apr 2021 --> Jul 2021
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio, Aliqopa (copanlisib) / Bayer
    Trial completion date, Trial termination, Trial primary completion date:  A Study to Determine Safety and Efficacy of (REMD-477) in Controlling Hyperglycemia Due to Copanlisib (clinicaltrials.gov) -  Jun 11, 2021   
    P1,  N=1, Terminated, 
    Not yet recruiting --> Recruiting | Initiation date: Apr 2021 --> Jul 2021 Trial completion date: Sep 2023 --> May 2021 | Recruiting --> Terminated | Trial primary completion date: Sep 2021 --> May 2021; poor accrual
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio, Aliqopa (copanlisib) / Bayer
    Trial completion date, Trial primary completion date:  A Study to Determine Safety and Efficacy of (REMD-477) in Controlling Hyperglycemia Due to Copanlisib (clinicaltrials.gov) -  Apr 22, 2021   
    P1,  N=6, Recruiting, 
    These data demonstrate that treatment with VOLA 35 mg or 70 mg once weekly as an adjunct to insulin is safe, well-tolerated, and decreases A1C with a trend toward decreased insulin dosing in people with T1D. Trial completion date: Mar 2023 --> Sep 2023 | Trial primary completion date: Mar 2021 --> Sep 2021
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio
    New P2 trial:  Effects of GRA in Patients With Type 1 (clinicaltrials.gov) -  Mar 2, 2021   
    P2,  N=30, Not yet recruiting, 
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio, Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca
    Enrollment open, Trial initiation date, Trial primary completion date:  Combination GRA and SGLT-2i Treatment in Type 1 Diabetes (clinicaltrials.gov) -  Feb 25, 2021   
    P1/2,  N=12, Recruiting, 
    Recruiting --> Completed Not yet recruiting --> Recruiting | Initiation date: Sep 2020 --> Feb 2021 | Trial primary completion date: Sep 2021 --> Dec 2021
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio
    Trial completion date, Trial primary completion date:  Metabolic Pathways of GRA in Patients With Type 1 Diabetes (clinicaltrials.gov) -  Feb 24, 2021   
    P1/2,  N=4, Active, not recruiting, 
    Not yet recruiting --> Recruiting | Initiation date: Sep 2020 --> Feb 2021 | Trial primary completion date: Sep 2021 --> Dec 2021 Trial completion date: Aug 2020 --> Oct 2021 | Trial primary completion date: Mar 2020 --> Jul 2021
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio, Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca
    New P1/2 trial:  Combination GRA and SGLT-2i Treatment in Type 1 Diabetes (clinicaltrials.gov) -  Sep 10, 2020   
    P1/2,  N=12, Not yet recruiting, 
  • ||||||||||  volagidemab (REMD-477) / Amgen, REMD Bio
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  Metabolic Pathways of GRA in Patients With Type 1 Diabetes (clinicaltrials.gov) -  Jun 9, 2020   
    P1/2,  N=4, Active, not recruiting, 
    Trial completion date: Sep 2020 --> Jan 2021 | Trial primary completion date: Jul 2020 --> Oct 2020 Not yet recruiting --> Active, not recruiting | N=10 --> 4 | Trial completion date: Dec 2019 --> Aug 2020 | Trial primary completion date: Dec 2019 --> Mar 2020