Type 2 Diabetes MellitusPhase 1/2NCT02455011
Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of REMD-477 in Subjects With Type 2 Diabetes Mellitus
A Phase 1/2 study testing REMD-477 in people with Type 2 Diabetes Mellitus and Diabetes, run by REMD Biotherapeutics, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetes
- What is being tested?
- REMD-477
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2015to Feb 2018
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Miami, Florida
Study site
Renton, Washington
Study site
San Antonio, Texas
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Single and Repeated Subcutaneous (SC) Doses of REMD-477 in Subjects With Type 2 Diabetes Mellitus
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.
Read the detailed description
The study will consist of three parts: Part A - Dose Escalation, Part B - Adaptive Dose Cohort, and Part C - REMD-477 in Combination with Metformin. Part A includes 5 cohorts that will be enrolled and dosed sequentially at escalating doses. Each cohort will consist of 12 subjects randomized in a 3:1 (active: placebo) fashion. Part B includes a single dose cohort that will enroll 12 subjects (9 on active treatment and 3 on placebo) with dose level and frequency determined by a Dose Level Review Meeting (DLRM)Committee. Part C includes 2 cohorts of T2DM patients currently treated with metformin alone, and each cohort will consist of 15 subjects (10 on active treatment and 3 on placebo).
- Conditions
- Type 2 Diabetes Mellitus, Diabetes
- Being tested
- REMD-477
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMD-477Biological
| Study group | Role | What they receive |
|---|---|---|
| REMD-477 Treatment A | Experimental | Administered as a single and repeated SC doses in subjects with Type 2 Diabetes Receives: Biological: REMD-477 |
| Matching placebo | Placebo comparator | Placebo administered as single and repeated SC doses in subjects with Type 2 Diabetes Receives: Biological: REMD-477 |
| REMD-477 Treatment B | Experimental | Administered as a single and repeated SC doses in subjects with Type 2 Diabetes Receives: Biological: REMD-477 |
| REMD-477 Treatment C | Experimental | Administered as a single and repeated SC doses in subjects with Type 2 Diabetes Receives: Biological: REMD-477 |
| REMD-477 Treatment D | Experimental | Administered as a single and repeated SC doses in subjects with Type 2 Diabetes Receives: Biological: REMD-477 |
| REMD-477 Treatment E | Experimental | Administered as a single and repeated SC doses in subjects with Type 2 Diabetes Receives: Biological: REMD-477 |
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: 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.
Measured: 141 Days
Changes in fasting glucose and insulin levels following single and repeated SC doses of REMD-477.
Measured: 141 Days
Changes in glucose and insulin AUC following a Mixed Meal Tolerance Test.
Measured: Day 29, Day 57 and Day 85
Incidence of REMD-477 neutralizing and non-neutralizing antibodies
Measured: 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.
Measured: 141 Days
Incidence and severity of elevated amylase and lipase values at >2.5x ULN after study treatment
Measured: 141 Days
Geometric mean ratio to baseline over time of AST, ALT, ALP and total bilirubin.
Measured: 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- REMD Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455011
- Sponsor's protocol ID
- R477-201
- Status last verified
- Apr 2018
- First submitted
- 20 May 2015
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Single and Repeated Subcutaneous (SC) Doses of REMD-477 in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02455011
- Acronym / sponsor ID
- R477-201
- Conditions
- Type 2 Diabetes Mellitus, Diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- REMD Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 27 May 2015 (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.
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.
Detailed description
The study will consist of three parts: Part A - Dose Escalation, Part B - Adaptive Dose Cohort, and Part C - REMD-477 in Combination with Metformin. Part A includes 5 cohorts that will be enrolled and dosed sequentially at escalating doses. Each cohort will consist of 12 subjects randomized in a 3:1 (active: placebo) fashion. Part B includes a single dose cohort that will enroll 12 subjects (9 on active treatment and 3 on placebo) with dose level and frequency determined by a Dose Level Review Meeting (DLRM)Committee. Part C includes 2 cohorts of T2DM patients currently treated with metformin alone, and each cohort will consist of 15 subjects (10 on active treatment and 3 on placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| REMD-477 Treatment A | Experimental | Biological: REMD-477Administered as a single and repeated SC doses in subjects with Type 2 Diabetes |
| Matching placebo | Placebo comparator | Biological: REMD-477Placebo administered as single and repeated SC doses in subjects with Type 2 Diabetes |
| REMD-477 Treatment B | Experimental | Biological: REMD-477Administered as a single and repeated SC doses in subjects with Type 2 Diabetes |
| REMD-477 Treatment C | Experimental | Biological: REMD-477Administered as a single and repeated SC doses in subjects with Type 2 Diabetes |
| REMD-477 Treatment D | Experimental | Biological: REMD-477Administered as a single and repeated SC doses in subjects with Type 2 Diabetes |
| REMD-477 Treatment E | Experimental | Biological: REMD-477Administered as a single and repeated SC doses in subjects with Type 2 Diabetes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (12 listed)
- 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);
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 | Matching placebo, REMD-477 Treatment A, REMD-477 Treatment B, REMD-477 Treatment C, REMD-477 Treatment D, REMD-477 Treatment E |
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: 141 Days
7 secondary outcomes
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.
Time frame: 141 Days
Changes in fasting glucose and insulin levels following single and repeated SC doses of REMD-477.
Time frame: 141 Days
Changes in glucose and insulin AUC following a Mixed Meal Tolerance Test.
Time frame: Day 29, Day 57 and Day 85
Incidence of REMD-477 neutralizing and non-neutralizing antibodies
Time frame: 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.
Time frame: 141 Days
Incidence and severity of elevated amylase and lipase values at >2.5x ULN after study treatment
Time frame: 141 Days
Geometric mean ratio to baseline over time of AST, ALT, ALP and total bilirubin.
Time frame: 141
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 10 Apr 2018.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing REMD-477 in people with Type 2 Diabetes Mellitus and Diabetes, run by REMD Biotherapeutics, Inc. at 3 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 10 inclusion and 12 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 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: 141 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2018.