Type 1 Diabetes MellitusPhase 1NCT02715193

Single-dose Study to Evaluate Safety, Tolerability, and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes Mellitus

A Phase 1 study testing REMD-477 in people with Type 1 Diabetes Mellitus and Diabetes, run by REMD Biotherapeutics, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Type 1 Diabetes Mellitus, Diabetes
What is being tested?: REMD-477
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 2 sitesUnited States
Study dates: Mar 2016to Jan 2017
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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;

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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).

Who cannot join

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;

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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;
Regular exercise >120 min/week within 14 days of Day 1;
Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;
Family history of multiple endocrine neoplasia.
Other inclusion and exclusion criteria may apply.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Study site
San Diego, California
Study site
St Louis, Missouri

Other trials in United States

About this study

Official title: A Randomized, Placebo-controlled, Double-blind, In-patient Study to Evaluate Safety, Tolerability, and Pharmacodynamics of REMD-477 Following a Single Dose in Subjects With Type 1 Diabetes Mellitus

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.

Read the detailed description

The study will be conducted at two sites in the United States, and approximately 20 subjects with type 1 diabetes will be enrolled. Eligible subjects will be admitted to the clinical research unit, to carefully monitor blood glucose; and establish the baseline insulin requirement for maintaining targeted normoglycemia (postabsorptive: 90-120 mg/dL; and postprandial: <180 mg/dL).

The patients will then be subjected to a hyperglycemic period (250-300 mg/dL) by a stepwise reduction in insulin infusion. After receiving a single SC dose of REMD-477 or matching placebo in a double-blinded fashion, all subjects will be assessed for the post-treatment 24-hour insulin requirement needed to maintain targeted normoglycemia (postabsorptive: 90-120 mg/dL; and postprandial: <180 mg/dL); and to be monitored closely for safety, tolerability and targeted glycemic control, for a 48-hr period. After the in-patient residency period, subjects will return to the clinic for weekly out-patient safety follow-up visits for 8 weeks.

Conditions: Type 1 Diabetes Mellitus, Diabetes
Being tested: REMD-477, Placebo Comparator
Medical subject headings: Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

REMD-477Biological
Placebo ComparatorBiological

Study groups in NCT02715193
Study group	Role	What they receive
REMD-477 Treatment A	Experimental	Administered as a single SC dose in subjects with Type 1 Diabetes Receives: Biological: REMD-477
Matching placebo	Placebo comparator	Administered as a single SC dose in subjects with Type 1 Diabetes Receives: Biological: Placebo Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of treatment emergent adverse events per subject, including changes in vital signs, physical and neurological examinations, laboratory safety tests and ECGs
Measured: 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.
Measured: 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
Measured: Baseline and 57 days
Changes from baseline over time of AST.
Incidence of elevated serum aspartate transaminase (AST) values > 3x the upper limit of normal (ULN).
Measured: Baseline and 57 days
Changes from baseline over time of ALT.
Incidence of elevated serum alanine transaminase (ALT) values >3x the upper limit of normal (ULN).
Measured: Baseline and 57 days
Changes from baseline over time of ALP.
Incidence of elevated serum alkaline phosphatase (ALP) >2x upper limit of normal (ULN)
Measured: Baseline and 57 days
Changes from baseline over time of total bilirubin.
Incidence of elevated serum total bilirubin >2x upper limit of normal (ULN).
Measured: Baseline and 57 days
Changes from baseline over time of amylase
Incidence of elevated serum amylase values at >2.5x ULN
Measured: Baseline and 57 days
Changes from baseline over time of lipase
Incidence of elevated serum lipase values at >2.5x ULN
Measured: Baseline and 57 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Jan 2017

First posted22 Mar 2016 (estimated)
Study startMar 2016
Primary completionJan 2017
Study completionJan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02715193
Sponsor's protocol ID: R477-101
Status last verified: Feb 2017
First submitted: 29 Feb 2016
Last updated: 7 Feb 2017
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 29283470

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-controlled, Double-blind, In-patient Study to Evaluate Safety, Tolerability, and Pharmacodynamics of REMD-477 Following a Single Dose in Subjects With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02715193
Acronym / sponsor ID: R477-101
Conditions: Type 1 Diabetes Mellitus, Diabetes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: REMD Biotherapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2016 (actual)
Primary completion: Jan 2017 (actual)
Study completion: Jan 2017 (actual)
First posted: 22 Mar 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
REMD-477 Treatment A	Experimental	Biological: REMD-477Administered as a single SC dose in subjects with Type 1 Diabetes
Matching placebo	Placebo comparator	Biological: Placebo ComparatorAdministered as a single SC dose in subjects with Type 1 Diabetes

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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;

Key exclusion criteria (19 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
REMD-477	Biological	REMD-477 Treatment A
Placebo Comparator	Biological	Matching placebo

Primary outcome

Number of treatment emergent adverse events per subject, including changes in vital signs, physical and neurological examinations, laboratory safety tests and ECGs
Time frame: 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.
Time frame: Baseline (24 hour period on Day 1) and Days 3 and 4

7 secondary outcomes

Immunogenicity: Incidence of REMD-477 neutralizing and non-neutralizing antibodies
Time frame: Baseline and 57 days
Changes from baseline over time of AST.
Time frame: Baseline and 57 days
Changes from baseline over time of ALT.
Time frame: Baseline and 57 days
Changes from baseline over time of ALP.
Time frame: Baseline and 57 days
Changes from baseline over time of total bilirubin.
Time frame: Baseline and 57 days
Changes from baseline over time of amylase
Time frame: Baseline and 57 days
Changes from baseline over time of lipase
Time frame: Baseline and 57 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
Derived from this study: PubMed 29283470Pettus 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.

Related trials for Type 1 Diabetes Mellitus

Active, not recruitingPhase 3
Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
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Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
Not yet recruiting
Safety and Efficacy of the Fully Closed Loop iLet Bionic Pancreas in Adults With Type 1 and Type 2 Diabetes
Diabetes (Insulin-requiring, Type 1 or Type 2)
Active, not recruitingPhase 2
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Active, not recruitingPhase 2
Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults and Adolescents on Top of Insulin Therapy (FABULINUS)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing REMD-477 in people with Type 1 Diabetes Mellitus and Diabetes, run by REMD Biotherapeutics, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of treatment emergent adverse events per subject, including changes in vital signs, physical and neurological examinations, laboratory safety tests and ECGs (time frame: Baseline and 57 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02715193, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.