Type1 Diabetes MellitusPhase 2NCT03117998

Multiple Dose Study to Evaluate the Efficacy, Safety and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes Mellitus

A Phase 2 study testing REMD-477 in people with Type1 Diabetes Mellitus, run by REMD Biotherapeutics, Inc. at 11 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type1 Diabetes Mellitus
What is being tested?: REMD-477
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 154 participants
Where: 11 sitesUnited States
Study dates: 19 Sep 2017to 5 Mar 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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. 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 32 kg/m2, inclusive, at screening;
Diagnosed with Type 1 diabetes, based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;
HbA1c > 7% and < 10 % at screening;

Show all 11Show fewer

Fasting C-peptide < 0.7 ng/mL;
Treatment with a stable insulin regimen for at least 8 weeks before screening with multiple daily insulin (MDI) injections or continue subcutaneous insulin infusion (CSII)
Willing to use continuous CGM system (e.g. DexCom) throughout the study;
Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 1.5x upper limit of normal (ULN) 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], known hemoglobinopathies, and renal dysfunction [eGFR < 60 ml/min]);
Any severe symptomatic hypoglycemic event associated with a seizure or requiring help from other people or medical facility in the past 6 months;
Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident ≤12 weeks before screening;
History of New York Heart Association Functional Classification III-IV cardiac disease;
Current or recent (within 1 month of screening) use of diabetes medications other than insulin - subjects on an SGLT2 inhibitor should be discontinue the SGLT2 inhibitor during the Screening Period, at least 2 weeks prior to the start of the Lead-in Period;

Show all 20Show fewer

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 > 10 cigarettes/day, and/or is unwilling to abstain from smoking during admission periods;
Known sensitivity to mammalian-derived drug preparations, recombinant protein-based drugs or to humanized or human antibodies;
History of illicit 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 (MEN) or family history of MEN;
History of pheochromocytoma, or family history of familial pheochromocytoma;
Known or suspected susceptibility to infectious disease (e.g. taking immunosuppressive agents or has a documented inherited or acquired immunodeficiency);
Known history of 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;
Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;
Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent
Other inclusion and exclusion criteria may apply.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Atlanta Diabetes Assoicates
Atlanta, Georgia, 30318
University of Colorado, Denver/Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
Texas Diabetes & Endocrinology
Austin, Texas, 78749
Dallas Diabetes Research Center
Dallas, Texas, 75230
AMCR Institute
Escondido, California, 92025
Marin Endocrine Care & Research
Greenbrae, California, 94904
Rainer Clinical Research Center
Renton, Washington, 98057
Clinical Trials of Texas
San Antonio, Texas, 78229
Altman Clinical and Translational Research Institute
San Diego, California, 92037
Washington University School of Medicine
St Louis, Missouri, 63110
Diablo Clinical Research
Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of Multiple Doses of REMD-477 in Subjects With Type 1 Diabetes Mellitus

This is a randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety, and pharmacodynamics (PD) of multiple doses of REMD-477 in subjects who have Type 1 diabetes and are currently receiving insulin treatment. This study will determine whether REMD-477 can decrease daily insulin requirements and improve glycemic control after 12 weeks of treatment in subjects diagnosed with Type 1 diabetes with fasting C-peptide < 0.7 ng/mL at Screening.

The study will be conducted at multiple sites in the United States. Approximately 150 subjects with type 1 diabetes on stable doses of insulin will be randomized in a 1:1:1 fashion into one of three treatment groups.

Conditions: Type1 Diabetes Mellitus
Being tested: REMD-477, Placebo Comparator

What participants receive

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

REMD-477Biological
Administered as repeated SC doses in subjects with Type 1 Diabetes
Placebo ComparatorBiological
Administered as a repeated SC doses in subjects with Type 1 Diabetes

Study groups in NCT03117998
Study group	Role	What they receive
35 mg REMD-477	Experimental	Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes Receives: Biological: REMD-477
70 mg REMD-477	Experimental	Administered as a repeated SC doses in subjects with Type 1 Diabetes Receives: Biological: REMD-477
Matching placebo	Placebo comparator	Administered as a repeated SC doses 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.

Change in Average Daily Total Insulin Use
Change from Baseline in average daily total insulin use at Week 12
Measured: Baseline and 12 weeks

Secondary outcomes (16)

Change From Baseline Difference in AUC Glucose Concentrations Following Mixed Meal Tolerance Test (MMTT) - Part A Only
Difference from baseline at Week 13 in AUC glucose concentration following the Mixed Meal Tolerance Test (MMTT) after repeated doses of REMD-477.
Measured: Baseline and 13 weeks; AUC glucose timepoints: 10 minutes prior and just before (time ) initiating the mixed-meal ingestion and at 30, 60 and 120 minutes after the mixed meal ingestion.
Continuous Glucose Monitoring (CGM) - Change in Average Daily 24-hour Glucose Concentration at Week 12
Change from baseline at Week 12 in average daily 24-h blood glucose as assessed by CGM after repeated doses of REMD-477.
Measured: Baseline and 12 weeks
Seven-Point Glucose Profile - Change in Average 24-h Glucose Concentrations
Change from baseline at Week 12 in the average daily 24-h blood glucose concentration as assessed by seven-point glucose profile after repeated doses of REMD-477. The 7-point blood glucose profiles includes measuring glucose via finger stick, at the following times of the day: before each meal, 2 hours after each meal, and at bedtime. The 7-point glucose profiles were obtained for 3 consecutive days before (Day 1) and for 3 consecutive days during week 12.
Measured: Baseline and 12 weeks
Summary of the Product of Average Daily 24-h Glucose Ratio and Daily Insulin Use Ratio (Day 78 [Week 12]/Baseline)
The product of the ratio of average glucose (Week 12/Baseline) and ratio of average insulin use (Week 12/Baseline).
Measured: Baseline and week 12
Change in Hemoglobin A1c From Baseline at Week 13
Change in Hemoglobin A1c from baseline at Week 13, after repeated doses of REMD-477.
Measured: Baseline and 13 weeks
Percentage of Subjects With HbA1c Reduction of ≥ 0.4% at Week 13
Proportion (percentage) of subjects who achieve HbA1c reduction of ≥ 0.4%, after repeated doses of REMD-477
Measured: Baseline and 13 weeks
Change in C-peptide Adjusted AUC Following Mixed Meal Tolerance Test (MMTT)
Change from baseline at Week 13 in the C-peptide adjusted AUC following MMTT after repeated doses of REMD-477.
Measured: Baseline and 13 weeks; AUC C-peptide timepoints: 10 minutes prior and just before (time 0) initiating the mixed-meal ingestion and at 30, 60 and 120 minutes after the mixed meal ingestion.
Change in Baseline Difference in Glucagon Adjusted AUC Following Mixed Meal Tolerance Test (MMTT) - Part A Only
Change from baseline at Week 13 in glucagon adjusted AUC after MMTT challenge, after repeated doses of REMD-477.
Measured: Baseline and 13 weeks; AUC glucagon timepoints: 10 minutes prior and just before (time ) initiating the mixed-meal ingestion and at 30, 60 and 120 minutes after the mixed meal ingestion.
Proportion of Subjects With Positive Anti-REMD-477 Antibodies
Proportion of subjects positive for anti-REMD-477 antibody formation.
Measured: Day 1 (pre-dose), Day 85 (Week 13) and Day 162 (Week 24)
Summary of REMD-477 Plasma Concentrations
REMD-477 serum-concentration after repeated doses of REMD-477.
Measured: Baseline (Day 1 pre-dose) and Weeks 2, 5, 9, 13 and 16.
Change in Hemoglobin A1c at Week 13 in Subjects With Baseline HbA1c ≥7.5%
Change in Hemoglobin A1c from baseline at Week 13, after repeated doses of REMD-477.
Measured: Baseline and 13 weeks
Proportion of Subjects With Targeted Hemoglobin A1C (HbA1c) of ≤ 7.0% at Week 13
Proportion (percentage) of subjects who achieve target HbA1c reduction of ≤ 7.0% at Week 13, after repeated doses of REMD-477
Measured: Baseline and 13 weeks
Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Target Blood Glucose Range (70-180 mg/dL) at Week 12
Change from baseline at Week 12 in percent time spent in target blood glucose range (70-180 mg/dL) after repeated doses of REMD-477.
Measured: Baseline and 12 weeks
Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hyperglycemia (Blood Glucose Range >180 mg/dL) at Week 12
Change from baseline at Week 12 in percent time spent in Hyperglycemia (Blood Glucose Range >180 mg/dL) after repeated doses of REMD-477.
Measured: Baseline and 12 weeks
Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hypoglycemia (Blood Glucose Range <70 mg/dL) at Week 12
Change from baseline at Week 12 in percent time spent in Hypoglycemia (Blood Glucose Range <70 mg/dL) after repeated doses of REMD-477.
Measured: Baseline and 12 weeks
Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hypoglycemia (Blood Glucose Range <55 mg/dL) at Week 12
Change from baseline at Week 12 in percent time spent in Hypoglycemia (Blood Glucose Range <55 mg/dL) after repeated doses of REMD-477.
Measured: Baseline and 12 weeks

Timeline

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

19 Sep 20175 Mar 2021

First posted18 Apr 2017
Study start19 Sep 2017
Primary completion5 Mar 2021
Study completion5 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type1 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03117998
Sponsor's protocol ID: R477-202
Status last verified: May 2023
First submitted: 10 Apr 2017
Last updated: 25 May 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Santiago Padilla L, Schiattarella GG. Targeting HFpEF: Unlocking the Potential of Glucagon Receptor Blockade. Circ Res. 2024 Aug 16;135(5):629-631. doi: 10.1161/CIRCRESAHA.124.325130. Epub 2024 Aug 15. No abstract available.
PubMed 39146397

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?

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Study at a glance

From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of Multiple Doses of REMD-477 in Subjects With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT03117998
Acronym / sponsor ID: R477-202
Conditions: Type1 Diabetes Mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: REMD Biotherapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 19 Sep 2017 (actual)
Primary completion: 5 Mar 2021 (actual)
Study completion: 5 Mar 2021 (actual)
First posted: 18 Apr 2017 (actual)
Results: Posted 25 May 2023

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
35 mg REMD-477	Experimental	Biological: REMD-477Administered as a repeated subcutaneous (SC) doses in subjects with Type 1 Diabetes
70 mg REMD-477	Experimental	Biological: REMD-477Administered as a repeated SC doses in subjects with Type 1 Diabetes
Matching placebo	Placebo comparator	Biological: Placebo ComparatorAdministered as a repeated SC doses in subjects with Type 1 Diabetes

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 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. 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 32 kg/m2, inclusive, at screening;
Diagnosed with Type 1 diabetes, based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;

Key exclusion criteria (20 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], known hemoglobinopathies, and renal dysfunction [eGFR < 60 ml/min]);
Any severe symptomatic hypoglycemic event associated with a seizure or requiring help from other people or medical facility in the past 6 months;
Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident ≤12 weeks before screening;
History of New York Heart Association Functional Classification III-IV cardiac disease;

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-477Administered as repeated SC doses in subjects with Type 1 Diabetes	Biological	35 mg REMD-477, 70 mg REMD-477
Placebo ComparatorAdministered as a repeated SC doses in subjects with Type 1 Diabetes	Biological	Matching placebo

Primary outcome

Change in Average Daily Total Insulin Use
Time frame: Baseline and 12 weeks
Change from Baseline in average daily total insulin use at Week 12

16 secondary outcomes

Change From Baseline Difference in AUC Glucose Concentrations Following Mixed Meal Tolerance Test (MMTT) - Part A Only
Time frame: Baseline and 13 weeks; AUC glucose timepoints: 10 minutes prior and just before (time ) initiating the mixed-meal ingestion and at 30, 60 and 120 minutes after the mixed meal ingestion.
Continuous Glucose Monitoring (CGM) - Change in Average Daily 24-hour Glucose Concentration at Week 12
Time frame: Baseline and 12 weeks
Seven-Point Glucose Profile - Change in Average 24-h Glucose Concentrations
Time frame: Baseline and 12 weeks
Summary of the Product of Average Daily 24-h Glucose Ratio and Daily Insulin Use Ratio (Day 78 [Week 12]/Baseline)
Time frame: Baseline and week 12
Change in Hemoglobin A1c From Baseline at Week 13
Time frame: Baseline and 13 weeks
Percentage of Subjects With HbA1c Reduction of ≥ 0.4% at Week 13
Time frame: Baseline and 13 weeks
Change in C-peptide Adjusted AUC Following Mixed Meal Tolerance Test (MMTT)
Time frame: Baseline and 13 weeks; AUC C-peptide timepoints: 10 minutes prior and just before (time 0) initiating the mixed-meal ingestion and at 30, 60 and 120 minutes after the mixed meal ingestion.
Change in Baseline Difference in Glucagon Adjusted AUC Following Mixed Meal Tolerance Test (MMTT) - Part A Only
Time frame: Baseline and 13 weeks; AUC glucagon timepoints: 10 minutes prior and just before (time ) initiating the mixed-meal ingestion and at 30, 60 and 120 minutes after the mixed meal ingestion.
Proportion of Subjects With Positive Anti-REMD-477 Antibodies
Time frame: Day 1 (pre-dose), Day 85 (Week 13) and Day 162 (Week 24)
Summary of REMD-477 Plasma Concentrations
Time frame: Baseline (Day 1 pre-dose) and Weeks 2, 5, 9, 13 and 16.
Change in Hemoglobin A1c at Week 13 in Subjects With Baseline HbA1c ≥7.5%
Time frame: Baseline and 13 weeks
Proportion of Subjects With Targeted Hemoglobin A1C (HbA1c) of ≤ 7.0% at Week 13
Time frame: Baseline and 13 weeks
Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Target Blood Glucose Range (70-180 mg/dL) at Week 12
Time frame: Baseline and 12 weeks
Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hyperglycemia (Blood Glucose Range >180 mg/dL) at Week 12
Time frame: Baseline and 12 weeks
Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hypoglycemia (Blood Glucose Range <70 mg/dL) at Week 12
Time frame: Baseline and 12 weeks
Continuous Glucose Monitoring (CGM) - Change in Percent Time Spent in Hypoglycemia (Blood Glucose Range <55 mg/dL) at Week 12
Time frame: Baseline and 12 weeks

Results and safety

Results posted to the registry on 25 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A - 35 mg REMD-477	25	24
Part A - 70 mg REMD-477	25	24
Part A - Matching Placebo	25	21
Part B - 35 mg REMD-477	26	22
Part B - 70 mg REMD-477	26	19
Part B - Matching Placebo	27	24

Primary outcome: Change in Average Daily Total Insulin Use

Time frame: Baseline and 12 weeks. Least squares mean (Standard Error). Unit: Units/day

Measure	Part A - 35 mg REMD-477 n = 21	Part A - 70 mg REMD-477 n = 22	Part A - Matching Placebo n = 15	Part B - 35 mg REMD-477 n = 21	Part B - 70 mg REMD-477 n = 20	Part B - Matching Placebo n = 22
Value	-6.72 (1.649)	-5.25 (1.634)	-1.37 (1.881)	-7.59 (2.142)	-6.64 (2.22)	-1.27 (2.103)

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events observed by the Principal Investigator or reported by subjects are collected and recorded in the eCRF, and, for serious adverse events (SAEs), on the SAE Report form. These AEs will include the following: • All serious adverse events that occur after the subject has signed the informed consent form up to the End of Study (Week 24 Visit). • All non-serious adverse events that occur after treatment with investigational product up to the End of Study (Week 24 Visit).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A - 35 mg REMD-477	0 of 25 (0%)	20 of 25 (80%)	0 of 25
Part A - 70 mg REMD-477	0 of 25 (0%)	18 of 25 (72%)	0 of 25
Part A - Matching Placebo	2 of 25 (8%)	20 of 25 (80%)	0 of 25
Part B - 35 mg REMD-477	1 of 26 (3.8%)	14 of 26 (53.8%)	0 of 26
Part B - 70 mg REMD-477	1 of 26 (3.8%)	18 of 26 (69.2%)	0 of 26
Part B - Matching Placebo	2 of 27 (7.4%)	9 of 27 (33.3%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39146397Santiago Padilla L, Schiattarella GG. Targeting HFpEF: Unlocking the Potential of Glucagon Receptor Blockade. Circ Res. 2024 Aug 16;135(5):629-631. doi: 10.1161/CIRCRESAHA.124.325130. Epub 2024 Aug 15. No abstract available.

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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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing REMD-477 in people with Type1 Diabetes Mellitus, run by REMD Biotherapeutics, Inc. at 11 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 20 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 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 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?

Yes. Results are posted in the registry (first posted 25 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Average Daily Total Insulin Use (time frame: Baseline and 12 weeks). 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 NCT03117998, 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 25 May 2023.