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Diabetes Mellitus, Type 1Phase 3GLITTER1NCT03371082

Gan & Lee Insulin Glargine Target Type (1) Evaluating Research

A Phase 3 study testing Gan & Lee Insulin Glargine Injection and Lantus® in people with Diabetes Mellitus, Type 1, run by Gan and Lee Pharmaceuticals, USA at 85 sites in 6 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

Primary Objective: •To evaluate equivalence of Gan \& Lee Insulin Glargine Injection and Lantus® in terms of immunogenicity Secondary Objective: Immunogenicity: To evaluate the percentage of subjects with negative anti-insulin antibodies (AIAs) at baseline who develop confirmed positive AIA up to Week 26, the… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Gan & Lee Insulin Glargine Injection and Lantus®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
576 participants
Where
85 sitesin 6 countries
Study dates
31 Oct 2017to 19 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or nonpregnant, nonlactating female subjects between the ages of 18 and 75 years, inclusive.
  • Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH GCP Guideline E6 and all applicable regulations, before initiating any study-related procedures.
  • Ability to understand and fully comply with all study procedures and restrictions.
  • Subjects with a confirmed diagnosis of type 1 diabetes mellitus who have been on an approved basal and bolus insulin regimen for at least 6 months (the type or brand of insulin should not have changed in the 6 months before screening).
  • HbA1c ≤ 11.0%.
  • BMI ≥ 19 kg/m2 and ≤ 35 kg/m2.
  • Adherence to a prudent diet and exercise regimen recommended by the medical provider, and willingness to maintain these consistently for the duration of the study.
  • Concomitant medications are allowed, provided that no significant dosing changes are anticipated during the study (see the exclusion criteria below for specific prohibited concomitant medications); for concomitant thyroid medications, subjects must have been on a stable dosage for 90 days before screening.

Who cannot join

  • Participation in another clinical study or use of any study drug within 30 days before screening.
  • Previous use of a biosimilar insulin, either basal or bolus.
  • Diabetic ketoacidosis within a year before screening.
  • Brittle type 1 diabetes mellitus within the year before screening (e.g., multiple hospitalizations related to diabetes mellitus and/or severe hypoglycemia for which the subject required 3rd party assistance).
  • Any severe, delayed sequela of diabetes mellitus, e.g., worsening end-stage renal disease, advanced coronary artery disease, or myocardial infarction within the year before screening, or autonomic peristaltic problems, e.g., gastroparesis.
  • Anticipated change in insulin used during the study (change in dosage is allowed, but change in type or brand of insulin will result in the subject being withdrawn from the study).
Show all 24Show fewer
  • Inadequately controlled thyroid disease, defined as a TSH or free T4 value > the upper limit of normal.
  • BMI < 19 kg/m2 or > 35 kg/m2.
  • Any clinically significant (in the opinion of the Investigator) hematology or chemistry test results at screening, including any liver function test > 3x the upper limit of normal (subjects with elevated bilirubin due to Gilbert syndrome are eligible to participate).
  • Documented history of anti-insulin antibodies.
  • Treatment with glucocorticosteroids, immunosuppressants, or cytostatic agents within 60 days before screening (newly-prescribed or high-dose corticosteroids are prohibited; chronically administered oral, inhaled, topical, or intra-articular corticosteroids at a stable dosage are allowed if no increase in dose is anticipated during the study; See Appendix 3 [Section 17.3] for a list of allowed and prohibited medications).
  • Current use of medication intended to cause weight loss or weight gain.
  • Alcohol or substance use disorder within the 2 years before screening.
  • Any previous or anticipated treatment with interferons.
  • Any history of malignant disease within 5 years before screening, except for adequately treated basal cell carcinoma.
  • Severe concomitant physical or psychiatric diseases or conditions
  • A history of a positive test result for HIV, hepatitis B, or hepatitis C; any subject who has a positive test result during the study may continue at the discretion of the Investigator.
  • Any history of pancreatitis or pancreatectomy.
  • Any diagnosis or condition that requires the subject to undergo procedures that could decrease antibodies in plasma or that would require treatment with immunosuppressant agents.
  • Any condition e.g., splenectomy, autoimmune disease, or rheumatologic disease, that could affect immunologic responses, could indicate an altered immune system, or could require treatment with a prohibited medication.
  • Any unresolved infection or a history of active infection within 30 days before screening other than mild or viral illness (as judged by the Investigator).
  • Any other disease or condition that in the opinion of the Investigator could confound the study results or limit the subject's ability to participate in the study or comply with follow-up procedures; or any other factor that would indicate a significant risk of loss to follow up.
  • Intolerance or history of hypersensitivity to insulin glargine or any excipient of IP.
  • Inability or unwillingness to wear the CGM sensor as required for the study, or to comply with the concomitant medication requirements in the FreeStyle Libre Pro Indications and Important Safety Information, during the CGM periods.

Trial locations and contacts

85 sites in 6 countries.

85 sites in 6 countries

United States50 sites

  • Texas Diabetes & Endocrinology - Central Austin

    Austin, Texas, 78731-4309

  • Texas Diabetes & Endocrinology - South Austin

    Austin, Texas, 78749

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • River Birch Research Alliance, LLC

    Blue Ridge, Georgia, 30513

  • Meridien Research

    Bradenton, Florida, 34201

  • Burke Internal Medicine & Research

    Burke, Virginia, 22105

  • University Diabetes & Endocrine Consultants

    Chattanooga, Tennessee, 37411

  • ClinSearch - Clinical Research Specialists

    Chattanooga, Tennessee, 37421

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

  • John H. Stroger Jr. Hospital of Cook County

    Chicago, Illinois, 60612

  • Endocrinology Reserach Associates, Inc.

    Columbus, Ohio, 43201

  • Aventiv Research, Inc.

    Columbus, Ohio, 43213-6523

  • Midwest CRC

    Crystal Lake, Illinois, 60012

  • Research Institute of Dallas

    Dallas, Texas, 75231

  • PriMed Clinical Research

    Dayton, Ohio, 45419

  • iResearch Atlanta

    Decatur, Georgia, 30030

  • Lillestol Research LLC

    Fargo, North Dakota, 58104

  • Stonesifer Clinical Research

    Federal Way, Washington, 98003

  • The Center for Diabetes and Endocrine Care

    Fort Lauderdale, Florida, 33312

  • Valley Research

    Fresno, California, 93720

  • Physicians East - Greenville

    Greenville, North Carolina, 27834

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut, 06517

  • Homestead Associates in Research

    Homestead, Florida, 33032

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • New Phase Research & Development

    Knoxville, Tennessee, 37909

  • Palm Research Center, Inc.

    Las Vegas, Nevada, 89148

  • Kentucky Diabetes Endocrinology Center

    Lexington, Kentucky, 40503-1473

  • Central Florida Endocrine and Diabetes Consultants - Maitland

    Maitland, Florida, 32751

  • Sestron Clinical Research

    Marietta, Georgia, 30060

  • Advanced Clinical Research - Idaho

    Meridian, Idaho, 83642

  • Biotech Pharmaceutical Group, LLC

    Miami, Florida, 33155

  • New Horizon Research Center

    Miami, Florida, 33175

  • Miami Dade Medical Research Institute, LLC

    Miami, Florida, 33176

  • Radiant Research

    Murray, Utah, 84123

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • The Rose Salter Medical Research Foundation

    Newport Beach, California, 92663-3303

  • California Medical Research Association

    Northridge, California, 91324

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Peninsula Research

    Ormond Beach, Florida, 32174

  • Oviedo Medical Research, LLC

    Oviedo, Florida, 32765

  • Rainier Clinical Research Center, Inc.

    Renton, Washington, 98057

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia, 30076

  • Texas Diabetes & Endocrinology - Round Rock

    Round Rock, Texas, 78681

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

  • Northeast Clinical Research of San Antonio

    Schertz, Texas, 78154

  • MultiCare Health System Institute for Research & Innovation

    Tacoma, Washington, 98405

  • Metabolic Institute of America

    Tarzana, California, 91356

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

Other trials in United States

Spain8 sites

  • Complejo Hospitalario Universitario La Coruña

    A Coruña, 15006

  • Complejo Hospitalario Universitario de Ferrol

    Ferrol, LA Coruna, 15405

  • Hospital Universitari de Girona Doctor Josep Trueta

    Girona, Gerona, 17007

  • Hospital Universitario Ramón Y Cajal

    Madrid, 28034

  • Centro de Especialidades San Jose Obrero. Hospital Universitario Virgen de la Victoria

    Málaga, Malaga, 29006

  • Nuevas Tecnologías en Diabetes y Endocrinología

    Seville, 41003

  • Hospital Universitario Nuestra Señora de Valme

    Seville, 41014

  • Consorci Hospital General Universitari de València

    Valencia, 46014

Other trials in Spain

Czechia7 sites

  • Diabetologie České Budějovice s.r.o

    České Budějovice, South Bohemian Region, 370 01

  • Diahaza s.r.o.

    Holešov, 769 01

  • StefaMed

    Hradec Králové, 503 41

  • Diabetologie MUDr. Tomáš Edelsberger

    Krnov, 794 01

  • PreventaMed

    Olomouc, 779 00

  • Genom s.r.o

    Ostrava, 709 00

  • Krajská zdravotní, a.s., Masarykova nemocnice v Ústí nad Labem

    Ústí nad Labem, Severoceský KRAJ, 401 13

Other trials in Czechia

Hungary7 sites

  • Lausmed Egeszsegugyi es Szolgaltato Kft.

    Baja, Bács-Kiskun county, 6500

  • Betegapolo-Irgalmasrend Budai Irgalmasrendi Kórház, Diabetológiai Ambulancia

    Budapest, 1023

  • Synexus Magyarország

    Budapest, 1036

  • Semmelweis Egyetem II. Sz. Belgyógyászati Klinika

    Budapest, 1088

  • Markhot Ferenc Oktatókórház és Rendelointézet

    Eger, Heves County, 3300

  • CRU Hungary Egészségügyi és Szolgáltató Kft.

    Miskolc, Borsod-Abauj Zemplen county, 3529

  • Zala County Hospital

    Zalaegerszeg, Zala County, H-8900

Other trials in Hungary

Poland7 sites

  • Centrum Badań Klinicznych PI-House

    Gdansk, Pomeranian Voivodeship, 80-546

  • Niepubliczny Zaklad Opieki Zdrowotnej Gdanska Poradnia Cukrzycowa

    Gdansk, Pomeranian Voivodeship, 80-858

  • Pratia MCM Kraków

    Krakow, Lesser Poland Voivodeship, 30-510

  • NZOZ Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne "Diab-Endo-Met"

    Krakow, Lesser Poland Voivodeship, 31-261

  • KO-MED Centra Kliniczne Lublin - Królewska

    Lublin, Lublin Voivodeship, 20-109

  • Praktyka Lekarska Ewa Krzyzagórska

    Poznan, Greater Poland Voivodeship, 61-655

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

    Warsaw, Masovian Voivodeship, 02-507

Other trials in Poland

Germany6 sites

  • Studienzentrum Aschaffenburg

    Aschaffenburg, Bavaria, 63739

  • Gemeinschaftspraxis Diabeteszentrum Dortmund

    Dortmund, North Rhine-Westphalia, 44137

  • Diabetes Schwerpunktpraxis, Gemeinschaftspraxis Alain Barakat und Helene Willems

    Duisburg, North Rhine-Westphalia, 47051

  • Diabetes-falkensee.de

    Falkensee, Brandenburg, 14612

  • RED-Institut GmbH

    Oldenburg in Holstein, Schleswig-Holstein, 23758

  • Diabetologische Schwerpunktpraxis Pirna

    Pirna, Saxony, 01796

Other trials in Germany

About this study

Official title: An Open Label, Randomized, Multicenter, Phase 3 Study to Compare the Immunogenicity, Efficacy and Safety of Gan & Lee Pharmaceuticals Insulin Glargine Injection to Lantus in Adult Subjects With Type 1 Diabetes Mellitus.

Primary Objective:

•To evaluate equivalence of Gan \& Lee Insulin Glargine Injection and Lantus® in terms of immunogenicity

Read more

Secondary Objective:

Immunogenicity:

  • To evaluate the percentage of subjects with negative anti-insulin antibodies (AIAs) at baseline who develop confirmed positive AIA up to Week 26, the percentage of baseline in AIA titers between treatment groups, the percentage of subjects with confirmed positive AIA who develop any anti-insulin neutralizing antibodies up to visit Week 26, and percentage of subjects who develop confirmed positive AIA up to visit Week 26 of Gan \& Lee Insulin Glargine Injection in comparison with that of Lantus®.

Safety:

•To evaluate the safety of Gan \& Lee Insulin Glargine Injection in comparison with that of Lantus®.

Efficacy:

•To evaluate the efficacy of Gan \& Lee Insulin Glargine Injection in comparison with that of Lantus®.

Being tested
Gan & Lee Insulin Glargine Injection, Lantus®
Keywords
Diabetes, Diabetes Type 1, Type 1, Basal, Insulin, Glargine, T1DM, Diabetes Mellitus, Insulin Dependent Diabetes
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance

What participants receive

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

  • Gan & Lee Insulin Glargine InjectionBiological

    Route of administration: subcutaneous injection

  • Lantus®Biological

    Route of administration: subcutaneous injection

Study groups in NCT03371082
Study groupRoleWhat they receive
Gan & Lee Insulin Glargine InjectionExperimentalGan \& Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan \& Lee injector pen. Subjects randomized to the Gan \& Lee Insulin Glargine Injection group will participate in the study for 26 weeks.
Receives: Biological: Gan & Lee Insulin Glargine Injection
Lantus®Active comparatorLantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL pre-filled insulin pen. Subjects randomized to the Lantus® group will participate for 26 weeks.
Receives: Biological: Lantus®

What is being measured

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

  1. Treatment-induced Anti-Insulin Antibody (TI-AIA)

    TI-AIA is the Composite of Newly Confirmed Positive AIA or Important-Increase in AIA titer

    Measured: Assessed up to Week 26

Secondary outcomes (8)

  1. Glycosylated Hemoglobin HbA1c

    The change between baseline (CFB) in HbA1c and at 26 weeks

    Measured: Assessed up to Week 26

  2. Number of Subjects in Each Treatment Group With Negative AIA at Baseline Who Develop Confirmed Positive AIA After Baseline

    The number of subjects in each treatment group with negative AIA at baseline who develop confirmed positive AIA after baseline and up to visit Week 26.

    Measured: Assessed up to Week 26

  3. Number of Subjects in Each Treatment Group With Confirmed Positive AIA at Baseline and at Least a 4-fold Increase in Titers After Baseline.

    The number of subjects in each treatment group with confirmed positive AIA at baseline and at least a 4-fold increase in titers after baseline and up to 26 weeks.

    Measured: Up to Week 26

  4. Mean Change From Baseline in Each Treatment Group in AIA Titers After Baseline

    The mean change from baseline in each treatment group in AIA titers after baseline and up to visit Week 26.

    Measured: Assessed up to Week 26

  5. Number of Subjects With Confirmed Positive AIA After Baseline Who Develop Any Anti-insulin Neutralizing Antibodies After Baseline.

    The number of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26 who develop any anti-insulin neutralizing antibodies after baseline and up to visit Week 26.

    Measured: Up to Week 26

  6. Number of Subjects With Confirmed Positive AIA After Baseline.

    The number of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26.

    Measured: Up to Week 26

  7. Postbaseline FBG Control

    The number of subjects who achieve an FBG test result of ≤ 6.0 mmol/L at visit Week 26.

    Measured: Up to Week 26

  8. HbA1c Control.

    The number of subjects who achieve a HbA1c of < 7.0% at visit Week 26.

    Measured: Up to Week 26

Timeline

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

  1. First posted13 Dec 2017
  2. Study start31 Oct 2017
  3. Primary completion19 Aug 2019
  4. Study completion19 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
Model description
Subjects who meet the study eligibility criteria will be centrally randomized 1:1 in an open-label fashion to receive either Gan \& Lee Insulin Glargine Injection or Lantus® for 26 weeks. Randomization will be stratified by country.
Masking
None (open label)
Enrolment
576 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03371082
Sponsor's protocol ID
GL-GLAT1-3001
Acronym
GLITTER1
Status last verified
Apr 2024
First submitted
20 Nov 2017
Last updated
14 May 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gan & Lee Insulin Glargine Injection and Lantus® in people with Diabetes Mellitus, Type 1, run by Gan and Lee Pharmaceuticals, USA at 85 sites in 6 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 8 inclusion and 24 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 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Spain, Czechia, Hungary, Poland and 1 more country. 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 14 May 2024). 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?

Treatment-induced Anti-Insulin Antibody (TI-AIA) (time frame: Assessed up to 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 NCT03371082.

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 14 May 2024.

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