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Diabetes Mellitus, Type 2Phase 3NCT03170518

A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus

A Phase 3 study testing Canagliflozin 100 mg and Canagliflozin 300 mg in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 106 sites in 10 countries.

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

The purpose of this study is to assess the effect of canagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and tolerability of canagliflozin. Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Canagliflozin 100 mg and Canagliflozin 300 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
171 participants
Where
106 sitesin 10 countries
Study dates
21 Jul 2017to 20 Sep 2023
Phase
Phase 3
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 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Participants with a diagnosis of type 2 diabetes mellitus (T2DM)
  • Random C-peptide at screening greater than (>)0.6 nanogram/milliliter (ng/mL) (>0.2 nanomole/liter [nmol]/L])
  • HbA1c of greater than or equal to (>=)6.5 percent (%) to less than or equal to (<=)11.0% and meets 1 of the inclusion criteria below:
  • On diet and exercise only for at least 4 weeks prior to screening
  • On diet and exercise and a stable dose of metformin monotherapy >=1,000 mg per day or MTD per day for at least 8 weeks prior to screening
  • On diet and exercise and a stable insulin monotherapy regimen for at least 8 weeks prior to screening (stable dose is defined as no change in the insulin regimen [that is, type{s} of insulin] and <=15% change in the total daily dose of insulin [averaged over 1 week to account for day to day variability])
  • On diet and exercise and a stable combination therapy with metformin and insulin for at least 8 weeks prior to screening

Who cannot join

  • History of diabetic ketoacidosis (DKA), type 1 diabetes mellitus (T1DM), pancreas or cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy or maturity onset diabetes of the young (MODY)
  • Participants on any antihyperglycemic agents (AHAs) other than metformin, or injectable insulin within 8 weeks of the first dose of study drug (that is Day 1)
  • Repeated (2 or more over a 1-week period) fasting self-monitoring of blood glucose (SMBG) measurements >270 milligram/deciliter (mg/dL) (>15 millimole/liter [mmol/L]) during the pretreatment phase, despite reinforcement of diet and exercise counseling
  • Severe hypoglycemia within 6 months prior to Day 1
  • History of hereditary glucose-galactose malabsorption or primary renal glucosuria
  • Alanine aminotransferase level >5.0 times the upper limit of normal (ULN) or total bilirubin >1.5 times the ULN at screening (for elevations in bilirubin: if, in the opinion of the investigator and agreed upon by the sponsor's medical officer, the elevation in bilirubin is consistent with Gilbert's disease, the subject may participate)

Trial locations and contacts

106 sites in 10 countries.

106 sites in 10 countries

United States36 sites

  • Appalachian Clinical Research

    Adairsville, Georgia, 30103

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • TOPAZ Clinical Research

    Apopka, Florida, 32703

  • University of Colorado School of Medicine/Children's Hospital Colorado

    Aurora, Colorado, 80045

  • Avant Research Associates, LLC

    Austin, Texas, 78709

  • AM Diabetes & Endocrinology Center

    Bartlett, Tennessee, 38133-4063

  • Floating Hospital For Children at Tufts Medical Center

    Boston, Massachusetts, 02111

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Capital Diabetes and Endocrine Associates

    Camp Springs, Maryland, 20746

  • Carolinas Research Center, LLC

    Charlotte, North Carolina, 28215

  • Cleveland Clinic Center for Pediatric Endocrinology

    Cleveland, Ohio, 44195

  • Endocrine Consultants Research

    Columbus, Georgia, 31904-4501

  • Buckeye Health and Research, LLC

    Columbus, Ohio, 43207

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411

  • Alas Viable Research

    Henderson, Nevada, 89014

  • Amir Ali Hassan, MD, PA

    Houston, Texas, 77089

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Sante Clinical Research

    Kerrville, Texas, 78028

  • Arkansas Childrens Hospital

    Little Rock, Arkansas, 72202

  • Texas Institute for Kidney and Endocrine Disorders

    Lufkin, Texas, 75904

  • LifeDoc Research, PLLC

    Memphis, Tennessee, 38115

  • Columbus Clinical Services LLC

    Miami, Florida, 33125

  • Medical Research Center of Miami II Inc

    Miami, Florida, 33134

  • Nicklaus Children's Hospital

    Miami, Florida, 33155

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029-6500

  • Nemours Children's Hospital/Endocrinology

    Orlando, Florida, 32827

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • WakeMed Clinical Research Institute

    Raleigh, North Carolina, 27610

  • Center of Excellence for Diabetes and Endocrinology (CEDE)

    Sacramento, California, 95821

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Asclepes Research

    Spring Hill, Florida, 34609

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701

  • MultiCare Health System

    Tacoma, Washington, 98405

  • American Institute of Research

    Whittier, California, 90603

  • Nemours DuPont Hospital for Children

    Wilmington, Delaware, 19803

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

Other trials in United States

Russia15 sites

  • Republic Children Clinical Hospital of the Ministry of Health of Udmurtskaya Republic

    Izhevsk, 426009

  • Kirov Clinical Hospital #7 named after V.I. Yurlova

    Kirov, 610014

  • Krasnoyarsk State Medical University

    Krasnoyarsk, 660022

  • Natiolal Medical Research Center of Endocrinology

    Moscow, 117036

  • Russian National Research Medical University named after N.I.Pirogov

    Moscow, 123317

  • Children City Clinical Hospital #1

    Novosibirsk, 630048

  • Omsk Regional Childrens Clinical Hospital

    Omsk, 644001

  • City Children Clinical Outpatient Clinic #5

    Perm, 614066

  • SBHI Children's City Multi-Profile Clinical Center named after K. A. Rauhfus

    Saint Petersburg, 191036

  • Children Outpatient Clinic 45 Of Nevskiy Region

    Saint Petersburg, 193312

  • Saint-Petersburg State Pediatric Medical Academy of RosZdrav, Clinical Diagnostic Center

    Saint Petersburg, 194100

  • Samara Regional Children Clinical Hospital named after N.N. Ivanova

    Samara, 443079

  • Siberian State Medical University

    Tomsk, 634050

  • Tver Regional Clinical Hospital

    Tver', 170100

  • Regional Pediatric Clinical Hospital No.1

    Yekaterinburg, 620149

Other trials in Russia

Brazil11 sites

  • Hospital Universitario Joao de Barros Barreto - UFPA

    Belém, 66073-000

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, 30150-221

  • Condominio Centro Clinico do Lago

    Brasília, 71625-009

  • Centro de Diabetes Curitiba Ltda

    Curitiba, 80810-040

  • Núcleo de Pesquisa Clinica

    Porto Alegre, 90430-001

  • Instituto da Criança com Diabetes do Rio Grande do Sul - ICDRS

    Porto Alegre, 91350-250

  • Ruschel Medicina e Pesquisa Clínica Ltda

    Rio de Janeiro, 22270 060

  • Hospital e Maternidade Dr Christovao da Gama S.A

    Santo André, 09030-010

  • IPEC - Instituto de Pesquisa Clínica Ltda

    São Paulo, 01223-001

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, 05403-000

  • Santa Casa de Misericórdia de Votuporanga

    Votuporanga, 15500-003

Other trials in Brazil

Mexico10 sites

  • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

    Aguascalientes, 20010

  • Instituto Nacional de Pediatría

    Coyoacán, 4530

  • Desarrollo Ético en Investigación Clínica S.C .

    Guadalajara, 44500

  • Centro de Estudios de Investigación Metabólicos y Cardiovasculares S.C.

    Madero, 89440

  • St Lucas Clinical Research Center

    Mérida, 97217

  • Bio Investigación AMARC, S.C.

    Mexico City, 11400

  • UBAM Unidad Biomédica Avanzada Monterrey

    Monterrey, 64460

  • Consultorio Medico

    Puebla City, 72190

  • Centro Integral Medico SJR, SC

    San Juan del Río, 76800

  • Centro De Investigacion Medica De Occidente, S.C.

    Zapopan, 45116

Other trials in Mexico

China8 sites

  • Capital Institute of Pediatrics

    Beijing, 100000

  • Xiangya Hospital Central South University

    Changsha, 410008

  • The Childrens Hospital Zhejiang University School Of Medicine

    Hangzhou, 310052

  • Jiangxi Provincial Children's Hospital

    Nanchang, 330006

  • Jiangsu Province Hospital

    Nanjing, 210029

  • Wuhan Union Hospital

    Wuhan, 430023

  • Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430030

  • Chidren's Hospital of Zhengzhou

    Zhengzhou, 450003

Other trials in China

India8 sites

  • Diacon Hospital

    Bangalore, 560010

  • Post Graduate Institute of Medical Education And Research PGIMER

    Chandigarh, 160012

  • Kovai Diabetes Specialty Centre & Hospital

    Coimbatore, 641 009

  • Quality Care India Limited

    Hyderabad, 500024

  • P D Hinduja National Hospital and Medical Research Center

    Mumbai, 400016

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • Jehangir Clinical Development Center Pvt Ltd

    Pune, 411001

  • Jothydev's Diabetes Research Centre

    Trivandrum, 695032

Other trials in India

Poland6 sites

  • Gornoslaskie Centrum Zdrowia, SPSK nr 6 Slaskiego Uniwersytetu Medycznego w Katowicach

    Katowice, 40-752

  • WSS Dzieciecy prof.dr S.Popowskiego w Olsztynie,Od.Pediatryczny VI Reumatologiczno-Endokrynologiczny

    Olsztyn, 10-561

  • Gabinet Pediatryczny Artur Mazur

    Rzeszów, 35 301

  • Instytut 'Pomnik-Centrum Zdrowia Dziecka', Klinika Endokrynologii i Diabetologii

    Warsaw, 04-730

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50 368

  • Specjalistyczna Praktyka Lekarska Aspiro

    Wroclaw, 50-341

Other trials in Poland

Malaysia5 sites

  • Hospital Sultanah Bahiyah

    Alor Star, 5460

  • Hospital Pulau Pinang

    George Town, 10990

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30990

  • Hospital Tuanku Fauziah

    Kangar, 1000

  • Hospital University Sains Malaysia

    Kubang Kerian, 16150

Other trials in Malaysia

Philippines5 sites

  • Chong Hua Hospital

    Cebu City, 6000

  • Norzel MedicaL and Diagnostic Clinic

    Cebu City, 6000

  • De La Salle Health Sciences Institute- DLSUMC

    Dasmariñas, 4114

  • Davao Doctors Hospital

    Davao City, 8000

  • Docbebet Diabetes Clinic

    San Fernando City, 2000

Other trials in Philippines

Greece2 sites

  • General Children's Hospital 'P. and A. Kyriakou'

    Athens, 11527

  • Athens Medical Center

    Athens, 15125

Other trials in Greece

About this study

Official title: A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (≥10 to <18 Years) With Type 2 Diabetes Mellitus

The purpose of this study is to assess the effect of canagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and tolerability of canagliflozin.

Being tested
Canagliflozin 100 mg, Canagliflozin 300 mg, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Canagliflozin 100 mgDrug

    Also called JNJ-28431754

    Canagliflozin 100 mg tablet will be administered orally (by mouth) once-daily.

  • Canagliflozin 300 mgDrug

    Also called JNJ-28431754

    Canagliflozin 300 mg tablet will be administered orally once-daily.

  • PlaceboDrug

    Matching placebo tablet will be administered orally once-daily.

Study groups in NCT03170518
Study groupRoleWhat they receive
Single-blind run-in Period: PlaceboExperimentalParticipants will receive 1 placebo tablet matching canagliflozin 100 milligram (mg) once-daily during the 2-week single-blind placebo run-in period.
Receives: Drug: Placebo
Double-blind Treatment Phase: Canagliflozin or PlaceboExperimentalCanagliflozin 100 mg/matching placebo once-daily during first 12 weeks. At Week 13, participants who have glycated hemoglobin (HbA1c) of greater than or equal to (>=)7.0 percent (%), estimated glomerular filtration rate (eGFR) >=60 milliliter/minute/1.73 meter square (mL/min/1.73 m^2) will be re-randomized to either remain on canagliflozin 100 mg/matching placebo or up-titrate to canagliflozin 300 mg/matching placebo till Week 52.
Receives: Drug: Canagliflozin 100 mg; Drug: Canagliflozin 300 mg; Drug: Placebo

What is being measured

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

  1. Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26

    Change from baseline in HbA1c at Week 26 was analyzed using a pattern mixture model with multiple imputation. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.

    Measured: Baseline (Day 1) and Week 26

  2. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

    An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAE was defined as the AEs occurring after first administration of double blind study intervention up to 30 days post last dose of study intervention.

    Measured: Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56)

Secondary outcomes (16)

  1. Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 26 and 52

    Change from baseline in FPG at Weeks 26 and Week 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.

    Measured: Baseline (Day 1), Weeks 26 and 52

  2. Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52

    The percentage of participants with HbA1c <7.5%, <7.0%, and <6.0% at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.

    Measured: Weeks 26 and 52

  3. Percentage of Participants Who Received Rescue Therapy

    Percentage of participants who received rescue therapy was reported. Participants who met glycemic rescue criteria that is with baseline HbA1c less than (<) 9.0 percent (%) and greater than (>) 0.8% change from baseline in HbA1c or with baseline HbA1c >=9% and >0.5% change from baseline in HbA1c received the glycemic rescue therapy. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.

    Measured: Baseline (Day 1) up to Week 52

  4. Time to Rescue Therapy

    Time to rescue therapy was planned to be reported. Participants who met glycemic rescue criteria that is with baseline HbA1c less than (<) 9.0 percent (%) and greater than (>) 0.8% change from baseline in HbA1c or with baseline HbA1c greater than or equal to (>=)9% and >0.5% change from baseline in HbA1c received the glycemic rescue therapy. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.

    Measured: Baseline (Day 1) up to Week 52

  5. Percent Change From Baseline in Body Weight at Weeks 26 and 52

    The percent change from baseline in body weight at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.

    Measured: Baseline (Day 1), Weeks 26 and 52

  6. Change From Baseline in Body Mass Index (BMI) at Weeks 26 and 52

    Change from baseline in BMI at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.

    Measured: Baseline (Day 1), Weeks 26, and 52

  7. Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52

    The percentage change from baseline in fasting plasma lipids (low-density lipoprotein-cholesterol [LDL-C], high-density lipoprotein-cholesterol [HDL-C], total cholesterol, non-HDL-C, and triglycerides) at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.

    Measured: Baseline (Day 1), Weeks 26, and 52

  8. Percent Change From Baseline in LDL-C to HDL-C Ratio and Non-HDL-C to LDL-C Ratio at Weeks 26 and 52

    The percentage change from baseline in LDL-C to HDL-C ratio and non-HDL-C to LDL-C ratio at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.

    Measured: Baseline (Day 1), Weeks 26, and 52

  9. Change From Baseline in Systolic Blood Pressure at Weeks 26 and 52

    Change from baseline in systolic blood pressure at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.

    Measured: Baseline (Day 1), Weeks 26 and 52

  10. Change From Baseline in Diastolic Blood Pressure at Weeks 26 and 52

    Change from baseline in diastolic blood pressure at Weeks 26 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.

    Measured: Baseline (Day 1), Weeks 26, and 52

  11. Change From Baseline in HbA1c at Weeks 12 and 52

    Change from baseline in HbA1c at Weeks 12 and 52 was reported. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.

    Measured: Baseline (Day 1), Weeks 12, and 52

  12. Growth Velocity at Weeks 26 and 52

    Growth velocity (increase in height per year) at Weeks 26 and 52 was reported. Growth velocity was derived from height measurements taken at baseline (Day 1), Week 26 and Week 52 visit. Growth velocity at Week 26 was derived as: (height at Week 26 - height at baseline)/(time from baseline to week 26. Similarly, growth velocity at Week 56 was derived.

    Measured: Baseline (Day 1) and Weeks 26 and 52

  13. Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52

    Tanner pubertal staging was assessed in female (F) for pubic hair growth and for breast development in stages (S) 1 to 5. If a participant had reached tanner S 5, no further Tanner pubertal S assessments were to be completed and reported as 'not done (ND)'. Tanner S Pubic hair growth: Pubic hair (1: No hair, 2: Downy hair, 3: More coarse and curly hair, 4: Adult-like hair quality; 5: Hair extends to medial surface of the thighs); Breast development: (1: The nipple is raised a little in this stage. The rest of the breast is still flat, 2: Breast bud forms,3: More elevated, outside areola, 4: Increased breast size, 5: Final adult-size breasts). Categories with at least 1 non-zero data values are reported. Baseline=B, Week=W.

    Measured: Baseline (Day 1), Weeks 26, and 52

  14. Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52

    Tanner pubertal staging was assessed in male (M) for pubic hair growth and for genitalia development in S 1 to 5. If a participant had reached Tanner S5, no further Tanner pubertal S assessments were to be completed and reported as ND. Tanner S pubic hair growth: Pubic hair (1: No hair, 2: little soft, long, lightly curled hair at penis 3: More coarse and curly hair covered larger area, 4: Adult-like hair quality; 5: Hair extends to medial surface of the thighs); Genitalia development: (1: Testes, scrotum, and penis about same size, 2: Enlargement of scrotum, testes, and penis, 3: Enlargement of penis, 4: The penis and glans became larger, 5: Genitalia size and shape same an adult male). Categories with at least 1 non-zero data values are reported. GD: genitalia development.

    Measured: Baseline (Day 1), Weeks 26, and 52

  15. Change From Baseline in Bone Turnover Marker: Serum Osteocalcin and Serum Collagen Type 1 Carboxy-Telopeptide (CTx) at Weeks 26 and 52

    Change from baseline in bone turnover marker: serum osteocalcin and CTx at Weeks 26 and 52 was reported.

    Measured: Baseline (Day 1), Weeks 26 and 52

  16. Urinary Albumin/Creatinine Ratio (ACR) at Weeks 26 and 52

    Urinary ACR at Weeks 26 and 52 was reported.

    Measured: Weeks 26 and 52

Timeline

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

  1. First posted31 May 2017
  2. Study start21 Jul 2017
  3. Primary completion20 Sep 2023
  4. Study completion20 Sep 2023

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03170518
Sponsor's protocol ID
CR108298
Other IDs
28431754DIA3018, 2016-005223-88, 2016
Status last verified
Apr 2025
First submitted
26 May 2017
Last updated
25 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Nadgir U, Ali SR, Gogate J, Shaw W, Antunes J, Fonseca S. Treatment With Canagliflozin Versus Placebo in Children and Adolescents With Type 2 Diabetes : A Randomized Clinical Trial. Ann Intern Med. 2025 Sep;178(9):1217-1226. doi: 10.7326/ANNALS-24-04017. Epub 2025 Aug 5.

    PubMed 40759025

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Canagliflozin 100 mg and Canagliflozin 300 mg in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 106 sites in 10 countries.

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 7 inclusion and 6 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 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Russia, Brazil, Mexico, China and 5 more countries. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 12 Mar 2025). 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 From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 (time frame: Baseline (Day 1) and Week 26). 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 NCT03170518, 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 Apr 2025.

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