NCT02455011

Brief Summary

This is a randomized, placebo-controlled, double-blind, dose escalation study to evaluate safety, tolerability, PK and PD of single and repeated SC doses of REMD-477 in Type 2 diabetic subjects. The study will be conducted at multiple sites in the United States and will enroll approximately 102 subjects with Type 2 diabetes who are either treatment-naïve, controlled with diet and exercise or treated with oral antidiabetic medications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P75+ for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

3 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

May 20, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

2.3 years

First QC Date

May 20, 2015

Last Update Submit

April 9, 2018

Conditions

Type 2 Diabetes MellitusDiabetes

Outcome Measures

Primary Outcomes (1)

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

    141 Days

Secondary Outcomes (7)

  • Pharmacokinetic (PK) profile (parameters including maximum observed concentration (Cmax), area under the curve (AUC) serum-concentration, clearance, and half-life (t1/2) after single and repeated SC doses.

    141 Days

  • Changes in fasting glucose and insulin levels following single and repeated SC doses of REMD-477.

    141 Days

  • Changes in glucose and insulin AUC following a Mixed Meal Tolerance Test.

    Day 29, Day 57 and Day 85

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

    141 Days

  • Incidence of elevated alanine transaminase (ALT) or aspartate transaminase (AST) values >3x the upper limit of normal with concomitant >2x increases in alkaline phosphatase (ALP) and/or >2x total bilirubin.

    141 Days

  • +2 more secondary outcomes

Study Arms (6)

REMD-477 Treatment A

EXPERIMENTAL

Administered as a single and repeated SC doses in subjects with Type 2 Diabetes

Biological: REMD-477

Matching placebo

PLACEBO COMPARATOR

Placebo administered as single and repeated SC doses in subjects with Type 2 Diabetes

Biological: REMD-477

REMD-477 Treatment B

EXPERIMENTAL

Administered as a single and repeated SC doses in subjects with Type 2 Diabetes

Biological: REMD-477

REMD-477 Treatment C

EXPERIMENTAL

Administered as a single and repeated SC doses in subjects with Type 2 Diabetes

Biological: REMD-477

REMD-477 Treatment D

EXPERIMENTAL

Administered as a single and repeated SC doses in subjects with Type 2 Diabetes

Biological: REMD-477

REMD-477 Treatment E

EXPERIMENTAL

Administered as a single and repeated SC doses in subjects with Type 2 Diabetes

Biological: REMD-477

Interventions

REMD-477BIOLOGICAL
Matching placeboREMD-477 Treatment AREMD-477 Treatment BREMD-477 Treatment CREMD-477 Treatment DREMD-477 Treatment E

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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, and females of child bearing potential must use two medically acceptable methods of contraception;
  • Male subjects must be willing to use clinically acceptable contraception during treatment and for 2 months after the last administration of REMD-477;
  • Normal or clinically-acceptable physical examination, laboratory test values, and 12-lead ECG (reporting heart rate and PR, QRS, QT, and QTcF) at screening;
  • Body mass index between 23 and 40 kg/m2, inclusive, at screening;
  • Diagnosed with Type 2 diabetes as defined by the current American Diabetes Association (ADA) criteria;
  • Subjects in Parts A and B only: Treatment-naive, controlled with diet and exercise, or treated with oral antidiabetic medications and willing to wash-out and discontinue oral medications during the study;
  • Fasting plasma glucose 126 - 270 mg/dL (7-15 mM), inclusive, at screening and at re-test on Day -1;
  • Subjects in Parts A and B only: Screening HbA1c of 7.0-10 % inclusive for subjects not currently taking any oral antidiabetic medications, or 6.5-9.5% for subjects receiving acceptable oral antidiabetic medications;
  • Subjects in Part C only: Screening HbA1c of 7.5-10 % inclusive for subjects on stable doses of metformin.

You may not qualify if:

  • History of drug or alcohol abuse within the last 6 months or a positive illegal drug urine test result;
  • History or family history of pancreatic neuroendocrine tumors or multiple endocrine neoplasia;
  • History or family history of 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\>300 mL, within 30 days of Day 1;
  • Recent use (6 weeks prior to Screening) of thiazolidinediones, \>half-maximal dose sulfonylurea agent therapy, or any injectable antidiabetic agents (exenatide and other injectable GLP-1 agonists, insulin and insulin analogs, etc.);
  • Other gastrointestinal, cardiac, renal and CNS (i.e. hypoglycemia unawareness) conditions specific to diabetes that would pose additional risk to subject's safety or interfere with the study evaluation, procedures or completion;
  • Lipid panel profiles of non-HDL-C (total cholesterol minus HDL-C) \>219 mg/dL, LDL-C \>189 mg/dL, and/or fasting triglycerides \>499 mg/dL;
  • Female subject is pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Renton, Washington, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

volagidemab

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

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

Study Record Dates

First Submitted

May 20, 2015

First Posted

May 27, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2018

Study Completion

February 1, 2018

Last Updated

April 10, 2018

Record last verified: 2018-04

Locations

US(3)