AzTrials
AzTrials

Type 1 Diabetes MellitusPhase 3PRONTO-T1DNCT03214367

A Study of LY900014 in Participants With Type 1 Diabetes

A Phase 3 study testing LY900014, Insulin Lispro and Insulin Glargine in people with Type 1 Diabetes Mellitus, run by Eli Lilly and Company at 172 sites in 20 countries.

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

The main purpose of this study is to evaluate the efficacy of the study drug LY900014 compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in adults with type 1 diabetes (T1D). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
LY900014, Insulin Lispro and Insulin Glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,392 participants
Where
172 sitesin 20 countries
Study dates
17 Jul 2017to 22 Aug 2019
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year.
  • HbA1c of ≥7.0 and ≤9.5%.
  • Use insulin lispro, insulin aspart, or insulin glulisine as prandial insulin.
  • Use insulin glargine, insulin detemir, insulin degludec, or neutral protamine Hagedorn (NPH) insulin as basal insulin.

Who cannot join

  • Have used other antihyperglycemic medications or therapies (inhaled, oral or injectable) within 90-days of screening.
  • Have had more than 1 severe hypoglycemic episode within 6 months of screening.
  • Have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of screening.
  • Have clinically significant gastrointestinal disease.

Trial locations and contacts

172 sites in 20 countries.

172 sites in 20 countries

United States44 sites

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • Barbara Davis Center for Childhood Diabetes

    Aurora, Colorado, 80045

  • Texas Diabetes and Endocrinology

    Austin, Texas, 78731-4309

  • Northwest Clinical Trials

    Boise, Idaho, 83704

  • Progressive Clinical Research

    Bountiful, Utah, 84010

  • University Diabetes and Endocrine Consultants

    Chattanooga, Tennessee, 37411

  • John Muir Physician Network Clinical Research Center

    Concord, California, 94520

  • Dallas Diabetes Endocrine Center

    Dallas, Texas, 75230

  • AMCR Institute INC

    Escondido, California, 92025

  • Private: Dr. Larry Stonesifer

    Federal Way, Washington, 98003

  • The Center For Diabetes & Endocrine Care

    Fort Lauderdale, Florida, 33312

  • Valley Endocrine, Fresno

    Fresno, California, 93720

  • Marin Endocrine Associates

    Greenbrae, California, 94904

  • Physicians East

    Greenville, North Carolina, 27843

  • East West Medical Institute

    Honolulu, Hawaii, 96814

  • Rocky Mountain Diabetes and Osteoporosis Center

    Idaho Falls, Idaho, 83404

  • East Coast Institute For Research

    Jacksonville, Florida, 32204

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Diabetes and Endocrine Associates

    La Mesa, California, 91942

  • Palm Research Center

    Las Vegas, Nevada, 89128

  • Palm Research Center

    Las Vegas, Nevada, 89148

  • Kentucky Diabetes Endocrinology Center

    Lexington, Kentucky, 40503

  • East Coast Institute For Research

    Macon, Georgia, 31210

  • Your Diabetes Endocrine Nutrition Group PC

    Mentor, Ohio, 44060

  • Internal Medicine Center LLC

    Mobile, Alabama, 36608

  • Diabetes & Endocrinology Consultants PC

    Morehead City, North Carolina, 28557

  • Southern New Hampshire Diabetes and Endocrinology

    Nashua, New Hampshire, 03063

  • Sun Coast Clinical Research, Inc

    New Port Richey, Florida, 34652

  • Manhattan Medical Research

    New York, New York, 10016

  • Partners in Nephrology & Endocrinology

    Pittsburgh, Pennsylvania, 15224

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia, 30076

  • Texas Diabetes and Endocrinology, P.A.

    Round Rock, Texas, 78681

  • Consano Clinical Research

    Shavano Park, Texas, 78231

  • Prairie Education and Research Cooperative

    Springfield, Illinois, 62711

  • Cotton O'Neil Diabetes and Endocrinology Center

    Topeka, Kansas, 66606

  • University Clinical Investigators, Inc.

    Tustin, California, 92780

  • Coastal Metabolic Research Centre

    Ventura, California, 93003

  • MassResearch

    Waltham, Massachusetts, 02453

  • Sudir Bansal M.D. Inc.

    Warwick, Rhode Island, 02886

  • Iderc, P.L.C.

    West Des Moines, Iowa, 50265

  • Metabolic Research Institute Inc.

    West Palm Beach, Florida, 33401

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

Other trials in United States

Japan19 sites

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    Amagasaki, 661

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    Fukuoka, 815-0071

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    Fukuoka, 815-8555

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    Kamakura, 247-0056

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    Kanagawa, 235-0045

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    Kumamoto, 862-0976

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    Miyazaki, 880-0034

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    Naka, 311-0113

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    Ōita, 870-0039

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    Ōsaka, 545-8586

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    Ōsaka, 569-1096

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    Sapporo, 060-0001

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    Sapporo, 060-0062

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    Sasebo, 857-1195

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    Shinjuku, 162-8666

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    Tokyo, 1030002

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    Tokyo, 143-0015

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    Tokyo, 160 0022

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    Tokyo, 206-0033

Other trials in Japan

Poland11 sites

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    Gdansk, 80-546

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    Krakow, 31-500

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    Lodz, 90-132

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    Lublin, 20-333

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    Lublin, 20-538

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    Ruda Śląska, 41-709

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    Szczecin, 70-376

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    Szczecin, 70-506

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    Warsaw, 01-518

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    Warsaw, 02-507

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    Wroclaw, 50-403

Other trials in Poland

Germany10 sites

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    Bad Mergentheim, 97980

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    Falkensee, 14612

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    Hamburg, 22607

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    Hessen, 35415

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    Magdeburg, 39112

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    Mayen, 56727

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    Münster, 48145

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    Oldenburg, 23758

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    Rheine, 67059

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    Saterland, 66386

Other trials in Germany

Romania10 sites

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    Bacau, 600164

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    Brasov, 500283

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    Bucharest, 013682

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    Lasi, 700547

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    Oradea, 410025

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    Ploieşti, 100163

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    Ploieşti, 100342

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    Satu Mare, 440055

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    Târgu Mureş, 540098

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    Timișoara, 300456

Other trials in Romania

Argentina9 sites

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    Buenos Aires, C1013AAB

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    Buenos Aires, C1056ABJ

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    Caba, C1179AAB

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    Caba, C1180AAX

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    Ciudad Autonoma de Buenos Aire, 1408

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    Ciudad Autonoma de Buenos Aire, C1128AAF

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    Córdoba, 5000

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    Córdoba, 5006

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    Mar del Plata, B7600FZN

Other trials in Argentina

Greece8 sites

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    Ampelokipoi, 11527

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    Athens, 11527

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    Athens, 17562

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    Larissa, 41110

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    Thermi, 57001

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    Thessaloniki, 54642

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    Thessaloniki, 54645

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    Thessaloniki, 57010

Other trials in Greece

India8 sites

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    Ahmedabad, 380015

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    Hyderabad, 500001

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    Hyderabad, 500035

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    Hyderabad, 500072

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    Indore, 452002

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    Pune, 411001

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    Secunderabad, 500033

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    Visakhapatnam, 530002

Other trials in India

Russia7 sites

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    Arkhangelsk, 163045

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    Kursk, 305014

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    Moscow, 117036

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    Moscow, 119435

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    Moscow, 123182

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    Saint Petersburg, 195257

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    Saratov, 410053

Other trials in Russia

Spain7 sites

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    Alzira, Valencia, 46600

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    Málaga, 29006

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    Sabadell, Barcelona, 08208

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    Seville, 41003

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    Seville, 41010

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    Seville, 41071

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    Teruel, 44002

Other trials in Spain

Taiwan6 sites

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    Chang-hua, 500

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    Taichung, 40201

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    Taichung, 40447

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    Tainan, 704

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    Taipei, 10507

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    Yongkang District, 71004

Other trials in Taiwan

Puerto Rico5 sites

  • Dr Altagracia Aurora Alcantara Gonzalez

    Bayamón, 00956

  • Advanced Clinical Research, LLC

    Bayamón, 00961

  • Manati Center for Clinical Research Inc

    Manati, 00674

  • Martha Gomez Cuellar M.D.

    San Juan, 00921

  • Centro de Endocrinologia del Este

    Yabucoa, 00767

Other trials in Puerto Rico

Australia4 sites

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    Box Hill, 3128

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    Geelong, 3220

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    Merewether, 2291

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    Oaklands Park, 5046

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Italy4 sites

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    Milan, 20132

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    Ravenna, 48121

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    Roma, 00161

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    Siena, 53100

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Mexico4 sites

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    Guadalajara, 44650

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    Monterrey, 64460

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    Monterrey, 64710

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    Zapopan, 45116

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New Zealand4 sites

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    Auckland, 2025

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    Christchurch, 8011

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    Takapuna, Auckland, 0620

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    Wellington, 6021

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Slovakia4 sites

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    Košice, 04012

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    Malacky, 90101

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    Nové Mesto nad Váhom, 91501

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    Rožňava, 048 01

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Sweden4 sites

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    Gothenburg, 41345

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    Linköping, 581 85

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    Lund, 22185

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    Stockholm, 14186

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Austria3 sites

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    Graz, 1060

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    Graz, 8036

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    Vienna, 1030

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Brazil1 site

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    São Paulo, 01244-030

Other trials in Brazil

About this study

Official title: A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro With an Open-Label Postprandial LY900014 Treatment Group, in Combination With Insulin Glargine or Insulin Degludec, in Adults With Type 1 Diabetes PRONTO-T1D

The main purpose of this study is to evaluate the efficacy of the study drug LY900014 compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in adults with type 1 diabetes (T1D).

Being tested
LY900014, Insulin Lispro, Insulin Glargine, Insulin Degludec
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • LY900014Drug

    Also called Ultra-Rapid Lispro

    Administered SC

  • Insulin LisproDrug

    Also called Humalog

    Administered SC

  • Insulin GlargineDrug

    Administered SC

  • Insulin DegludecDrug

    Administered SC

Study groups in NCT03214367
Study groupRoleWhat they receive
LY900014ExperimentalLY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Receives: Drug: LY900014; Drug: Insulin Glargine; Drug: Insulin Degludec
Insulin Lispro (Humalog)Active comparatorInsulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Receives: Drug: Insulin Lispro; Drug: Insulin Glargine; Drug: Insulin Degludec
LY900014 Postmeal (Open Label)ExperimentalLY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
Receives: Drug: LY900014; Drug: Insulin Glargine; Drug: Insulin Degludec
LY900014 - Maximum Extended Enrollment (MEE)ExperimentalLY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Receives: Drug: LY900014; Drug: Insulin Glargine; Drug: Insulin Degludec
Insulin Lispro (Humalog)-MEEActive comparatorInsulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Receives: Drug: Insulin Lispro; Drug: Insulin Glargine; Drug: Insulin Degludec
LY900014 Postmeal (Open Label)-MEEExperimentalLY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
Receives: Drug: LY900014; Drug: Insulin Glargine; Drug: Insulin Degludec

What is being measured

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

  1. Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

    Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.

    Measured: Baseline, Week 26

Secondary outcomes (11)

  1. Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26

    A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. 1-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.

    Measured: Baseline, Week 26

  2. Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26

    A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. 2-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.

    Measured: Baseline, Week 26

  3. Rate of Severe Hypoglycemia at Week 26

    Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group *36525.

    Measured: Baseline through Week 26

  4. Rate of Documented Symptomatic Hypoglycemia at Week 26

    Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of <54 mg/dL [3.0 millimole per liter (mmol/L)]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable.

    Measured: Baseline through Week 26

  5. Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26

    1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug.

    Measured: Baseline, Week 26

  6. Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26

    SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug.

    Measured: Baseline, Week 26

  7. Change From Baseline in Insulin Dose at Week 26

    LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data prior to permanent discontinuation of study drug.

    Measured: Baseline, Week 26

  8. Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26

    ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS Mean was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. The analysis included data prior to permanent discontinuation of study drug.

    Measured: Baseline, Week 26

  9. Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26

    ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS Mean was calculated using the analysis of covariance (ANCOVA) with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. The analysis included data prior to permanent discontinuation of study drug.

    Measured: Baseline, Week 26

  10. Percentage of Participants With HbA1c <7%

    Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

    Measured: Week 26

  11. Change From Baseline in HbA1c at Week 52

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

    Least Squares (LS) mean was determined by MMRM model with variables of baseline, pooled country, type of basal insulin during lead-in, prandial Insulin Dosing Plan, treatment (Type III sum of squares) as fixed factors. The analysis included data prior to permanent discontinuation of study drug.

    Measured: Baseline, Week 52

Timeline

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

  1. First posted11 Jul 2017
  2. Study start17 Jul 2017
  3. Primary completion6 Sep 2018
  4. Study completion22 Aug 2019

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
1,392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03214367
Sponsor's protocol ID
16313
Other IDs
I8B-MC-ITRM, 2015-005356-99, 2015
Acronym
PRONTO-T1D
Status last verified
Sep 2019
First submitted
10 Jul 2017
Last updated
1 May 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Piras de Oliveira C, Dellva MA, Bue-Valleskey J, Chang AM, Liao B. Fasting and postprandial plasma glucose contributions to hemoglobin A1c and time in range in people with diabetes on multiple daily injection insulin therapy: Results from the PRONTO-T1D and PRONTO-T2D clinical trials. J Diabetes Complications. 2024 Jan;38(1):108648. doi: 10.1016/j.jdiacomp.2023.108648. Epub 2023 Nov 16.

    PubMed 38035641

  • Miura J, Nishiyama H, Imori M. Long-term Efficacy and Safety of Ultra Rapid Lispro in Japanese Patients With Type 1 Diabetes: Subpopulation Analysis of the 52-Week PRONTO-T1D Study. Diabetes Ther. 2021 Sep;12(9):2471-2484. doi: 10.1007/s13300-021-01124-9. Epub 2021 Aug 4.

    PubMed 34347267

  • Bue-Valleskey J, Klaff L, Cho JI, Dellva MA, Schloot NC, Tobian J, Miura J, Dahl D. Long-Term Efficacy and Safety of Ultra Rapid Lispro (URLi) in Adults with Type 1 Diabetes: The PRONTO-T1D Extension. Diabetes Ther. 2021 Feb;12(2):569-580. doi: 10.1007/s13300-020-00987-8. Epub 2021 Jan 17.

    PubMed 33458803

  • Miura J, Imori M, Nishiyama H, Imaoka T. Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog(R) in Japanese Patients with Type 1 Diabetes: PRONTO-T1D Subpopulation Analysis. Diabetes Ther. 2020 Sep;11(9):2089-2104. doi: 10.1007/s13300-020-00892-0. Epub 2020 Jul 29.

    PubMed 32728832

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LY900014, Insulin Lispro and Insulin Glargine in people with Type 1 Diabetes Mellitus, run by Eli Lilly and Company at 172 sites in 20 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 4 inclusion and 4 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 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 172 sites in United States, Japan, Poland, Germany, Romania and 15 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 1 May 2020). 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 Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26 (time frame: Baseline, Week 26). 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 NCT03214367, which also lists 4 linked publications.

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 1 May 2020.

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