NCT02715193

Brief Summary

This is a randomized, placebo-controlled, double-blind study to evaluate safety, tolerability and pharmacodynamics of REMD-477 in subjects who have Type 1 diabetes and are currently receiving insulin treatment. This proof of concept study will determine whether glucagon receptor blockade using a single dose REMD-477 can improve short-term glucose homeostasis in people with Type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 29, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

February 29, 2016

Last Update Submit

February 6, 2017

Conditions

Type 1 Diabetes MellitusDiabetes

Outcome Measures

Primary Outcomes (2)

  • Number of treatment emergent adverse events per subject, including changes in vital signs, physical and neurological examinations, laboratory safety tests and ECGs

    Baseline and 57 days

  • Changes from baseline in 24-hour insulin requirements on Day 1 relative to the two 24 hour periods post-treatment on Days 3 and 4, between the REMD-477 and placebo treated subjects, needed to maintain targeted glycemic control.

    Baseline (24 hour period on Day 1) and Days 3 and 4

Secondary Outcomes (7)

  • Immunogenicity: Incidence of REMD-477 neutralizing and non-neutralizing antibodies

    Baseline and 57 days

  • Changes from baseline over time of AST.

    Baseline and 57 days

  • Changes from baseline over time of ALT.

    Baseline and 57 days

  • Changes from baseline over time of ALP.

    Baseline and 57 days

  • Changes from baseline over time of total bilirubin.

    Baseline and 57 days

  • +2 more secondary outcomes

Study Arms (2)

REMD-477 Treatment A

EXPERIMENTAL

Administered as a single SC dose in subjects with Type 1 Diabetes

Biological: REMD-477

Matching placebo

PLACEBO COMPARATOR

Administered as a single SC dose in subjects with Type 1 Diabetes

Biological: Placebo Comparator

Interventions

REMD-477BIOLOGICAL
REMD-477 Treatment A
Placebo ComparatorBIOLOGICAL
Matching placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women between the ages of 18 and 60 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 26.9 kg/m2, inclusive, at screening;
  • Diagnosed with Type 1 diabetes for greater than 2 years, based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;
  • HbA1c ≥6.0 % but \<9.0 % at screening;
  • Fasting C-peptide \<0.2 ng/mL;
  • Current use of insulin pump and willing to use continuous glucose monitoring (CGM) system (e.g. DexCom) throughout the entire study;
  • ALT and/or AST within \<1.5x ULN at screening;
  • Serum amylase and lipase within normal limits at screening;
  • Able to provide written informed consent approved by an Institutional Review Board (IRB).

You may not qualify if:

  • History or evidence of clinically-significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
  • Significant organ system dysfunction (e.g., clinically significant pulmonary or cardiovascular disease, anemia \[Hemoglobin \<10.0 g/dL\], and renal dysfunction \[eGFR \<90 ml/1.73M2/min\]);
  • Any severe symptomatic hypoglycemic event associated with a seizure or requiring help from other people or medical facility in the past 6 months;
  • Current or recent (within 1 month of screening) use of diabetes medications other than insulin;
  • Use of steroids and/or other prescribed or over-the-counter medications that are known to affect the outcome measures in this study or known to influence glucose metabolism;
  • Smokes tobacco;
  • Known sensitivity to mammalian-derived drug preparations, recombinant protein-based drugs or to humanized or human antibodies;
  • History of illegal 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;
  • History of pheochromocytoma, or family history of familial pheochromocytoma;
  • Known or suspected susceptibility to infectious disease (eg, taking immunosuppressive agents or has a documented inherited or acquired immunodeficiency);
  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Related Publications (1)

  • Pettus J, Reeds D, Cavaiola TS, Boeder S, Levin M, Tobin G, Cava E, Thai D, Shi J, Yan H, Bautista E, McMillan J, Unger R, Henry RR, Klein S. Effect of a glucagon receptor antibody (REMD-477) in type 1 diabetes: A randomized controlled trial. Diabetes Obes Metab. 2018 May;20(5):1302-1305. doi: 10.1111/dom.13202. Epub 2018 Jan 22.

    PMID: 29283470DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Interventions

volagidemab

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 22, 2016

Study Start

March 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

US(2)