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Diabetes Mellitus, Type 2Phase 2NCT02390050

A Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets in Subjects With Type 2 Diabetes Mellitus

A Phase 2 study testing Bexagliflozin tablets in people with Diabetes Mellitus, Type 2, run by Theracos at 50 sites in 2 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 was to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM). Bexagliflozin is an orally administered drug for the treatment of T2DM and is classified as a Sodium Glucose co-Transporter 2 (SGLT2) Inhibitor. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Bexagliflozin tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
292 participants
Where
50 sitesin 2 countries
Study dates
12 May 2015to 3 Jun 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

The following subjects were eligible for randomization:

  1. men or women ≥ 20 years of age at screening. Women of childbearing potential must test negative by urine pregnancy test.
  2. were treatment naïve or taking one oral anti-diabetic medication in combination with diet and exercise
  3. were diagnosed with T2DM with HbA1c levels at screening between 7.0% and 8.5% (inclusive) if treatment naïve or with HbA1c levels between 6.5 and 8.5% (inclusive) if on one oral anti-diabetic medication
  4. had a body mass index (BMI) ≤ 40 kg/m2
  5. were taking stable doses of medication for hypertension or hyperlipidemia that has not changed for at least 30 days prior to screening (if applicable)
  6. were able to comprehend the study participation requirements and willing to provide written informed consent in accordance with institutional and regulatory guidelines
  7. were able to maintain adequate glycemic control at the run-in visit (for subjects who complete the washout)
  8. had an HbA1c between 7.0 and 8.5% (inclusive) prior to randomization (day -3 to -5)
  9. were capable of adhering to the investigational product administration requirements as evidenced by omission of no more than one dose of run-in medication

Subjects who exhibited any of the following characteristics were to be ineligible for randomization:

  1. Diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young
  2. Used parenteral therapy for treatment of diabetes
  3. Pregnancy or current breastfeeding status
  4. Hemoglobinopathy or carrier status for hemoglobin alleles that affect HbA1c measurement
  5. Genitourinary tract infection within 6 weeks of screening or history of ≥3 genitourinary infections requiring treatment within 6 months of screening
  6. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 at screening.
  7. Uncontrolled hypertension at screening
  8. A positive result on hepatitis B surface antigen, hepatitis C, or positive result from screen for drugs of abuse
  9. History of human immunodeficiency virus infection
  10. Life expectancy < 2 years
  11. History of New York Heart Association Class 4 heart failure within 3 months of screening
  12. History of myocardial infarction, unstable angina, stroke, or hospitalization for heart failure within 3 months of screening
  13. History of treatment with an investigational drug within 30 days or within 7 half lives of the investigational drug, whichever is longer
  14. Previous treatment with bexagliflozin
  15. Had taken or within 6 months of taking any Sodium Glucose Transporter 2 (SGLT2) inhibitors prior to screening
  16. Participation of another interventional trial
  17. Not able to comply with the study scheduled visits
  18. Affected by any condition, disease, disorder, or clinically relevant abnormality that, in the opinion of the investigator, would jeopardize the subject's appropriate participation in this study.
  19. Liver function tests resulting in Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 2.5 x upper limit of normal (ULN) or total bilirubin ≥ 1.5 x ULN, with the exception of isolated Gilbert's syndrome ,at screening
  20. Exhibited fasting plasma glucose ≥ 250 mg/dL (13.9 mmol/L) on two or more consecutive days prior to randomization or exhibited severe clinical signs or symptoms of hyperglycemia during the washout or run-in periods, including weight loss, blurred vision, increased thirst, or increased urination, or fatigue
  21. Fasting Plasma Glucose ≥ 250 mg/dL at randomization
  22. Prior renal transplantation or evidence of nephrotic syndrome, defined as a urine albumin-to-creatinine ratio (UACR) > 2000 mg/g at screening

Trial locations and contacts

50 sites in 2 countries.

50 sites in 2 countries

United States32 sites

  • PICR Clinic

    Atlanta, Georgia, 30338

  • Calabash Medical Center

    Calabash, North Carolina, 28467

  • Hope Clinical Research, LLC

    Canoga Park, California, 91303

  • Catalina Research Institute

    Chino, California, 91710

  • CTI Research

    Cincinnati, Ohio, 45255

  • Global Medical Research

    DeSoto, Texas, 75115

  • Regional Clinical Research, Inc

    Endwell, New York, 13760

  • M&O Clinical Research LLC

    Fort Lauderdale, Florida, 33316

  • Rockwood Medical Clinic

    Fort Worth, Texas, 76164

  • AGA Clinical Trials

    Hialeah, Florida, 33012

  • National Research Institute

    Huntington Park, California, 90255

  • Detweiler Family Medicine and Associate, P.C.

    Lansdale, Pennsylvania, 19446

  • Compass Research North

    Leesburg, Florida, 34748

  • Long Beach Clinical Trials

    Long Beach, California, 90806

  • Sweet Hope Research Specialty, Inc

    Miami Lakes, Florida, 33016

  • Diabetes & Endocrinology Consultants PC

    Morehead City, North Carolina, 28557

  • North Myrtle Beach Family Practice

    Myrtle Beach, South Carolina, 29582

  • Synergy San Diego

    National City, California, 91950

  • Sunshine Research Center

    Opa-locka, Florida, 33054

  • Compass Research LLC

    Orlando, Florida, 32806

  • Phoenix Medical Research Institute LLC

    Peoria, Arizona, 85381

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Columbia Research Group, Inc.

    Portland, Oregon, 97239

  • Northern California Research

    Sacramento, California, 95821

  • PMG Research of Salisbury

    Salisbury, North Carolina, 28144

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • Artemis Institute for Clinical Research, LLC

    San Diego, California, 92103

  • Sundance Clinical Research

    St Louis, Missouri, 63141

  • Summit Research Group, LLC

    Stow, Ohio, 44224

  • Premier Research Ltd

    Trenton, New Jersey, 08611

  • Advanced Arizona Clinical Research

    Tucson, Arizona, 85712

  • Infosphere Clinical Research, Inc

    West Hills, California, 91307

Other trials in United States

Japan18 sites

  • Medical Corp. SEIKOUKAI New Medical Research System Clinic

    Hachioji-shi, Tokyo, 192-0046

  • Medical Corporation Segawa Hospital

    Hikigun Ogawamachi, Saitama, 355-0328

  • Ikeoka Medical Corp. Ikeoka Clinic

    Joto-ku, Osaka, 536-0008

  • Medical Corporation Jototowakai Shinkoiwa ekimae sogo Clinic

    Katsushika-ku, Tokyo, 124-0024

  • Medical Corporation Yukeikai Asano Clinic

    Kawagoe-shi, Saitama, 350-0851

  • Medical Corporation Ishii Internal Medicine Clinic

    Kawaguchi, Saitama, 333-0844

  • Medical Corporation IHL Pedi Shiodome Medical Clinic

    Minato-ku, Tokyo, 105-7390

  • Medical Corporation IHL Shinagawa East One Medical Clinic

    Minato-ku, Tokyo, 108-0075

  • Medical Corporation Hayashi katagihara Clinic

    Nishikyo-ku, Kyoto, 615-8125

  • Kenkokan Suzuki Clinic

    Ōta-ku, Tokyo, 143-0015

  • Medical Corporation Fusanokai Shimizu Clinic Fusa

    Saitama-shi, Saitama, 336-0963

  • Medical Corporation Souyu-kai Hirahata Clinic

    Shibuya-ku, Tokyo, 150-0002

  • Medical Corporation Yuhokai Miho-Clinic

    Shinagawa-ku, Tokyo, 141-0032

  • Miyauchi Medical Center

    Takatsuki-shi, Osaka, 569-1123

  • Ikebukuro Metropolitan Clinic

    Toshima-ku, Tokyo, 171-0021

  • Medical Corporation Senrichuo Ekimae Clinic

    Toyonaka-shi, Osaka, 560-0082

  • Medical Corporation KEISEIKAI Kajiyama clinic

    Ukyou-ku, Kyoto, 615-0035

  • Medical Corporation Hitomi-kai Motomachi Takatsuka Naika Clinic

    Yokohama Naka-ku, Kanagawa, 231-0023

Other trials in Japan

About this study

Official title: A Phase 2b, Multi-center, Double-blind, Placebo-controlled, Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets on HbA1c in Subjects With Type 2 Diabetes Mellitus

The purpose of this study was to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM). Bexagliflozin is an orally administered drug for the treatment of T2DM and is classified as a Sodium Glucose co-Transporter 2 (SGLT2) Inhibitor. This study was to enroll both treatment naive and those subjects previously treated with one oral hypoglycemic agent (OHA). Approximately 320 subjects eligible for randomization was to receive bexagliflozin tablets, 5, 10, 20 mg or placebo, once daily for 12 weeks in an outpatient setting.

Read the detailed description

The study was a phase 2b multicenter, double-blind, placebo-controlled parallel group study to assess the effect of once daily bexagliflozin tablets on HbA1c in either treatment-naïve T2DM subjects or in subjects who were treated with one oral anti-diabetic agent. Treatment naïve subjects were eligible if their HbA1c values were between 7% and 8.5% at the screening visit while subjects who were treated with one oral hypoglycemic agent (OHA) were eligible if their HbA1c value was between 6.5% and 8.5% at screening and underwent a 6 or 10 week washout period. In addition, all eligible subjects underwent a two week placebo run-in period and those who showed good compliance in taking study medication (i.e., missed no more than one dose during the run-in period) during this period and whose HbA1c values were between 7 and 8.5% at the end of the run-in period were eligible for randomization.

Being tested
Bexagliflozin tablets, Bexagliflozin tablets, 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.

  • Bexagliflozin tabletsDrug

    Also called Code name: EGT0001442

    Bexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.

  • Bexagliflozin tablets, placeboDrug

    Bexagliflozin tablets, placebo, are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.

Study groups in NCT02390050
Study groupRoleWhat they receive
Bexagliflozin tablets, 5 mgActive comparatorBexagliflozin tablets, 5 mg, once daily by mouth before breakfast
Receives: Drug: Bexagliflozin tablets
Bexagliflozin tablets, 10 mgActive comparatorBexagliflozin tablets, 10 mg, once daily by mouth before breakfast
Receives: Drug: Bexagliflozin tablets
Bexagliflozin tablets, 20 mgActive comparatorBexagliflozin tablets, 20 mg, once daily by mouth before breakfast
Receives: Drug: Bexagliflozin tablets
Bexagliflozin tablets, placeboPlacebo comparatorBexagliflozin tablets, placebo, once daily by mouth before breakfast
Receives: Drug: Bexagliflozin tablets, placebo

What is being measured

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

  1. Change in HbA1c After 12 Weeks of Treatment

    Mixed model repeated measures (MMRM) analysis of covariance model (ANCOVA) with baseline HbA1c as a covariate will be fit to the available data, incorporating all visits at which HbA1c was measured for each subject including scheduled visits at Weeks 2, 6, and 12 as well as unscheduled visits for measurements of HbA1c. Treatment (placebo, 5 mg, 10 mg, 20 mg), study center, prior anti-diabetic treatment status, study visit and treatment-by-visit interaction will be applied as fixed effects and subject as a random effect. The least square mean (LSM) change from baseline to Week 12 was analyzed using the Mixed-Effect Model Repeated Measure (MMRM) Analysis of Covariance (ANCOVA) model using 95% Confidence Intervals (CIs) for the between-group mean changes.

    Measured: 12 weeks

Secondary outcomes (5)

  1. Proportion of Subjects With HbA1c < 7%

    To assess the efficacy of bexagliflozin based on the proportion of subjects who reach the American Diabetes Associate (ADA) and the Japan Diabetes Society target HbA1c of <7%.

    Measured: Baseline to up to 12 weeks

  2. Change in Body Weight Over Time

    The body weight was analyzed on the full analysis set using the MMRM ANCOVA model used for the primary efficacy analysis.

    Measured: Baseline to Week 2, Week 6 and Week 12

  3. Change in Fasting Plasma Glucose (FPG) Over Time

    The fasting plasma glucose (FPG) was analyzed on the full analysis set using the same MMRM ANCOVA model used in the primary efficacy analysis.

    Measured: Baseline to Week 2, Week 6 and Week 12

  4. Change in Systolic and Diastolic Blood Pressure Over Time

    The systolic blood pressure (SBP) and diastolic blood pressure (DBP) were analyzed on the full analysis set using the same MMRM ANCOVA model used in the primary efficacy analysis.

    Measured: Baseline to Week 2, Week 6 and Week 12

  5. Change in HbA1c Over Time

    The least square mean (LSM) change from baseline to Week 2, Week 6 and Week 12 was analyzed using the Mixed-Effect Model Repeated Measure (MMRM) Analysis of Covariance (ANCOVA) model using 95% Confidence Intervals (CIs) for the between-group mean changes. The LSM change was calculated by excluding HbA1c data obtained after rescue medication.

    Measured: Baseline to Week 2, Week 6 and Week 12

Timeline

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

  1. First posted17 Mar 2015 (estimated)
  2. Study start12 May 2015
  3. Primary completion3 Jun 2016
  4. Study completion3 Jun 2016

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02390050
Sponsor's protocol ID
THR-1442-C-449
Status last verified
Jun 2021
First submitted
11 Mar 2015
Last updated
29 Jun 2021
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • American Diabetes Association. Standards of medical care in diabetes--2014. Diabetes Care. 2014 Jan;37 Suppl 1:S14-80. doi: 10.2337/dc14-S014. No abstract available.

    PubMed 24357209

  • Look AHEAD Research Group; Wing RR, Bolin P, Brancati FL, Bray GA, Clark JM, Coday M, Crow RS, Curtis JM, Egan CM, Espeland MA, Evans M, Foreyt JP, Ghazarian S, Gregg EW, Harrison B, Hazuda HP, Hill JO, Horton ES, Hubbard VS, Jakicic JM, Jeffery RW, Johnson KC, Kahn SE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montez MG, Murillo A, Nathan DM, Patricio J, Peters A, Pi-Sunyer X, Pownall H, Reboussin D, Regensteiner JG, Rickman AD, Ryan DH, Safford M, Wadden TA, Wagenknecht LE, West DS, Williamson DF, Yanovski SZ. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med. 2013 Jul 11;369(2):145-54. doi: 10.1056/NEJMoa1212914. Epub 2013 Jun 24.

    PubMed 23796131

  • Matsuo S, Imai E, Horio M, Yasuda Y, Tomita K, Nitta K, Yamagata K, Tomino Y, Yokoyama H, Hishida A; Collaborators developing the Japanese equation for estimated GFR. Revised equations for estimated GFR from serum creatinine in Japan. Am J Kidney Dis. 2009 Jun;53(6):982-92. doi: 10.1053/j.ajkd.2008.12.034. Epub 2009 Apr 1.

    PubMed 19339088

  • National Research Council (US) Panel on Handling Missing Data in Clinical Trials. The Prevention and Treatment of Missing Data in Clinical Trials. Washington (DC): National Academies Press (US); 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK209904/

    PubMed 24983040

  • Palaniappan LP, Wong EC, Shin JJ, Fortmann SP, Lauderdale DS. Asian Americans have greater prevalence of metabolic syndrome despite lower body mass index. Int J Obes (Lond). 2011 Mar;35(3):393-400. doi: 10.1038/ijo.2010.152. Epub 2010 Aug 3.

    PubMed 20680014

  • Santer R, Kinner M, Lassen CL, Schneppenheim R, Eggert P, Bald M, Brodehl J, Daschner M, Ehrich JH, Kemper M, Li Volti S, Neuhaus T, Skovby F, Swift PG, Schaub J, Klaerke D. Molecular analysis of the SGLT2 gene in patients with renal glucosuria. J Am Soc Nephrol. 2003 Nov;14(11):2873-82. doi: 10.1097/01.asn.0000092790.89332.d2.

    PubMed 14569097

  • Scheen AJ, Van Gaal LF. Combating the dual burden: therapeutic targeting of common pathways in obesity and type 2 diabetes. Lancet Diabetes Endocrinol. 2014 Nov;2(11):911-22. doi: 10.1016/S2213-8587(14)70004-X. Epub 2014 Feb 19.

    PubMed 24731666

  • Schwartz S, Fabricatore AN, Diamond A. Weight reduction in diabetes. Adv Exp Med Biol. 2012;771:438-58. doi: 10.1007/978-1-4614-5441-0_31.

    PubMed 23393695

  • van den Heuvel LP, Assink K, Willemsen M, Monnens L. Autosomal recessive renal glucosuria attributable to a mutation in the sodium glucose cotransporter (SGLT2). Hum Genet. 2002 Dec;111(6):544-7. doi: 10.1007/s00439-002-0820-5. Epub 2002 Sep 27.

    PubMed 12436245

  • Japan Diabetes Society (2012). Treatment Guidance for Diabetes 2012-2013.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bexagliflozin tablets in people with Diabetes Mellitus, Type 2, run by Theracos at 50 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c After 12 Weeks of Treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02390050, which also lists 10 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 29 Jun 2021.

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Clinical Trial NCT02390050 | AzTrials