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Diabetes Mellitus, Type 2Phase 3GLITTER 2NCT03371108

Gan & Lee Insulin Glargine Target Type (2) Evaluating Research

A Phase 3 study testing Gan & Lee Insulin Glargine Injection and Lantus® in people with Diabetes Mellitus, Type 2, run by Gan and Lee Pharmaceuticals, USA at 57 sites in United States.

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 (AIA) at baseline who develop confirmed positive AIA up to Week 26, the percentage… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
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
567 participants
Where
57 sitesUnited States
Study dates
31 Oct 2017to 17 Apr 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 2 diabetes mellitus who meet one of the following:
  • If insulin-naïve, subjects should have been on at least 2 approved OAMs for at least 12 weeks before screening, and the clinician has decided to add insulin therapy.
  • If already being treated with a basal and/or bolus insulin, subjects should have been treated with insulin for at least 6 months in addition to at least 1 approved OAM, and must not have changed the type or brand of insulin within 6 months prior to screening.
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  • HbA1c values as follows:
  • If insulin-naïve, HbA1c ≤ 11.0%.
  • If previously on a basal insulin regimen, HbA1c ≥ 7.0% and ≤ 11.0%.
  • Body mass index (BMI) ≤ 45 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 2 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).
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  • Inadequately controlled thyroid disease, defined as a TSH or free T4 value > the upper limit of normal.
  • BMI > 45 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 concomitant 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

57 sites in 1 country.

57 sites in 1 country

United States57 sites

  • Austin Regional Clinic

    Austin, Texas, 78726

  • Texas Diabetes & Endocrinology - Central Austin

    Austin, Texas, 78731-4309

  • Texas Diabetes & Endocrinology - South Austin

    Austin, Texas, 78749

  • Simon Williamson Clinic

    Birmingham, Alabama, 35211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3407

  • 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 Associates, Inc.

    Columbus, Ohio, 43201

  • Aventiv Research, Inc.

    Columbus, Ohio, 43213-6523

  • Midwest CRC

    Crystal Lake, Illinois, 60012

  • 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, PA

    Greenville, North Carolina, 27834

  • Mountain View Clinical Research

    Greer, South Carolina, 29651

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut, 06517

  • Homestead Associates in Research

    Homestead, Florida, 33032

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Clinical Investigations Specialists-Wisconsin

    Kenosha, Wisconsin, 53144

  • Sante Clinical Research

    Kerrville, Texas, 78028

  • New Phase Research & Development

    Knoxville, Tennessee, 37909

  • Palm Research Center, Inc.

    Las Vegas, Nevada, 89128

  • Kentucky Diabetes Endocrinology Center

    Lexington, Kentucky, 40503-1473

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Sestron Clinical Research

    Marietta, Georgia, 30060

  • ActivMed Practices and Research - Methuen

    Methuen, Massachusetts, 01844

  • Biotech Pharmaceutical Group, LLC

    Miami, Florida, 33155

  • Genoma Research Group

    Miami, Florida, 33165

  • 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 Coast, California, 92657

  • California Medical Research Association

    Northridge, California, 91324

  • Peninsula Research

    Ormond Beach, Florida, 32174

  • Oviedo Medical Research

    Oviedo, Florida, 32765

  • Family Practice Specialists

    Phoenix, Arizona, 85018

  • Rainier Clinical Research Center, Inc.

    Renton, Washington, 98057

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia, 30076

  • Texas Diabetes & Endocrinology - Round Rock

    Round Rock, Texas, 78681

  • Northern California Research Corp.

    Sacramento, California, 95821

  • 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

  • Terence T. Hart, MD

    Tuscumbia, Alabama, 35674

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • Metabolic Research Institute

    West Palm Beach, Florida, 33401

Other trials in United States

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 2 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 (AIA) at baseline who develop confirmed positive AIA up to Week 26, the percentage of subjects with at least a 4-fold increase in titers compared to baseline value, mean change from 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 the percentage of subjects in each treatment group with confirmed positive AIA up to visit Week 26

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 2, Type 2, Basal, Insulin, Glargine, T2DM, Diabetes Mellitus
Medical subject headings
Diabetes Mellitus, Type 2, 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 NCT03371108
Study groupRoleWhat they receive
Gan & Lee Insulin Glargine InjectionExperimentalGan \& Lee Insulin Glargine Injection solution for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0 mL prefilled 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® solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3.0 mL prefilled 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) is the Primary Endpoint

    Subjects were classified as experiencing a TI-AIA or not. A TI-AIA is defined as a subject experiencing a newly confirmed positive AIA status, if they were negative at baseline or a 4-fold increase in their titer values if they were positive. The primary outcome measure is summarized as the percent of subjects experiencing a TI-AIA in the group.

    Measured: Baseline to Week 26

Secondary outcomes (8)

  1. CFB in HbA1c to Week 26

    Change is HbA1c value at week 26 minus the value at baseline.

    Measured: Baseline to Week 26

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

    The percentage 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: Baseline to Week 26

  3. Immunogenicity - Percentage of Subjects in Each Treatment Group With Confirmed Positive AIA at Baseline Who Developed at Least a 4-fold Increase in Titers After Baseline

    The percentage of subjects in each treatment group with confirmed positive AIA at baseline (n=6) who developed an important increase (at least a 4-fold increase in titers after baseline) up to visit Week 26.

    Measured: Baseline to Week 26

  4. Immunogenicity - 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: Baseline to Week 26

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

    The percentage 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: Baseline to Week 26

  6. Immunogenicity - Percentage of Subjects With Confirmed Positive AIA After Baseline

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

    Measured: Baseline to Week 26

  7. Efficacy - Postbaseline FBG Control

    The number and percentage of subjects who achieve an FBG test result of ≤ 8.0 mmol/L (≤ 144.0 mg/dL) at visit Week 26.

    Measured: Baseline to Week 26

  8. Efficacy - HbA1c Control

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

    Measured: At 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 completion17 Apr 2019
  4. Study completion17 Apr 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.
Masking
None (open label)
Enrolment
567 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03371108
Sponsor's protocol ID
GL-GLAT2-3002
Acronym
GLITTER 2
Status last verified
Dec 2021
First submitted
20 Nov 2017
Last updated
1 Apr 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Christofides EA, Puente O, Norwood P, Denham D, Maheshwari H, Lillestol M, Hart T, Nakhle S, Chadha A, Fitz-Patrick D, Sugimoto D, Soufer J, Young D, Warren M, Huffman D, Reed J, Bays H, Arora S, Rizzardi B, Tidman R, Rendell M, Johnson KA. Immunogenicity, efficacy, and safety of biosimilar insulin glargine (Gan & Lee glargine) compared with originator insulin glargine (Lantus(R)) in patients with type 2 diabetes after 26 weeks' treatment: A randomized open label study. Diabetes Obes Metab. 2024 Jun;26(6):2412-2421. doi: 10.1111/dom.15560. Epub 2024 Apr 1.

    PubMed 38558508

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 2, run by Gan and Lee Pharmaceuticals, USA at 57 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 12 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 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 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. 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 23 Mar 2022). 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) is the Primary Endpoint (time frame: Baseline 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 NCT03371108, 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 1 Apr 2022; AzTrials last refreshed its copy on 1 Nov 2026.

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