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The purpose of the study is to evaluate the efficacy of EGT0001442 in lowering glycosylated Hemoglobin (HbA1c, A laboratory test to diagnose three months average of blood sugar)levels at 24th week from baseline, when compared to placebo group(no diabetic medication given). The secondary aim of the study is to evaluate the efficacy of EGT0001442 in lowering fasting blood glucose at the weeks 2 and 24 and comparing the results with placebo group. This study assess the efficacy of EGT0001442 based on the proportion of subjects who reach the American Diabetes Association (ADA) target of HbA1c of < 7% in EGT0001442 group and comparison with placebo. The study also evaluates the effect of EGT0001442 on systolic, diastolic pressures, body weight and compare with the respective placebo groups.This study also assess the change from baseline in HbA1c overtime, from week 1 to week 96. Finally, to assess the safety of EGT0001442 in the Type 2 Diabetic patients (adult/maturity onset).
EGT0001442 is a compound that may inhibit the effect of other compounds in the body known as sugar transporters. The use of EGT0001442 may enhance the elimination of glucose from the blood by increasing the amount of urine produced. Hence the blood glucose levels are significantly decreased and the efficacy of EGT001442 can be established by assessing the three months average blood glucose levels (HbA1c). Due to the increased urinary output, the effect of EGT001442 on blood pressure levels are also assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGT0001442 | Experimental | EGT0001442 capsule, 20 mg, daily, 96 weeks |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGT0001442 | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c at 24 Weeks | Changes from baseline in HbA1c in placebo and treatment group at end of 24 weeks treatment | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Systolic and Diastolic Blood Pressure at Week 24 | Changes from baseline in systolic and diastolic blood pressure in placebo and treatment group after 24 weeks of treatment | Baseline and Week 24 |
| Changes in Body Weight at Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mason W Freeman, M.D. | Massachusetts General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 5 | Buena Park | California | United States | |||
| Site 4 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21193625 | Background | American Diabetes Association. Standards of medical care in diabetes--2011. Diabetes Care. 2011 Jan;34 Suppl 1(Suppl 1):S11-61. doi: 10.2337/dc11-S011. No abstract available. | |
| 15624123 | Background | Ehrenkranz JR, Lewis NG, Kahn CR, Roth J. Phlorizin: a review. Diabetes Metab Res Rev. 2005 Jan-Feb;21(1):31-8. doi: 10.1002/dmrr.532. |
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| ID | Title | Description |
|---|---|---|
| FG000 | EGT0001442 | EGT0001442 capsule, 20 mg, orally once daily |
| FG001 | Placebo | Placebo capsule, orally once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EGT0001442 | EGT0001442 capsule, 20 mg, orally once daily |
| BG001 | Placebo | Placebo capsule, 20 mg, orally once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin A1c at 24 Weeks | Changes from baseline in HbA1c in placebo and treatment group at end of 24 weeks treatment | Number of subjects with a value at baseline and at the specified visit | Posted | Least Squares Mean | Standard Error | percentage of glycated hemoglobin | Baseline and Week 24 |
|
The adverse event data were collected from Week 0 (Visit 3) up to Week 97 (Visit 15, 1 week follow-up after completion of study).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EGT0001442 | EGT0001442 capsule, 20 mg, orally once daily | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Albert Collinson, Ph.D. | Theracos Sub, LLC | (508) 688-4221 | acollinson@theracos.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2011 | Mar 26, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2011 | Mar 26, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000705992 | bexagliflozin |
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| Drug |
|
Changes from baseline in body weight in placebo and treatment group after 24 weeks of treatment
| Baseline and week 24 |
| Change From Baseline in HbA1c Over 96 Weeks Time | Change from baseline in HbA1c level over 96 weeks in placebo and treatment group. The treatment group was treated with EGT0001442 for 24 weeks. | Baseline and up to 96 weeks |
| Change From Baseline Over Time in Fasting Plasma Glucose (FPG) | Changes from baseline in FPG in placebo and treatment group over 24 weeks of treatment | 24 weeks |
| Percentage of Subjects Achieving HbA1c <7% | The number and percentage of subjects achieving HbA1c response levels <7% for the FAS using LOCF is reported | Baseline and up to 96 weeks |
| Los Angeles |
| California |
| United States |
| Site 3 | Santa Ana | California | United States |
| Site 1 | Hialeah | Florida | United States |
| Site 9 | Berlin | New Jersey | United States |
| Site 7 | Cary | North Carolina | United States |
| Site 6 | Marion | Ohio | United States |
| Site 8 | Munroe Falls | Ohio | United States |
| Site 2 | Portland | Oregon | United States |
| Site 11 | North Richland Hills | Texas | United States |
| Site 7 | San Antonio | Texas | United States |
| 20566676 | Background | Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care. 2010 Oct;33(10):2217-24. doi: 10.2337/dc10-0612. Epub 2010 Jun 21. |
| 18356408 | Background | Han S, Hagan DL, Taylor JR, Xin L, Meng W, Biller SA, Wetterau JR, Washburn WN, Whaley JM. Dapagliflozin, a selective SGLT2 inhibitor, improves glucose homeostasis in normal and diabetic rats. Diabetes. 2008 Jun;57(6):1723-9. doi: 10.2337/db07-1472. Epub 2008 Mar 20. |
| 19129748 | Background | Komoroski B, Vachharajani N, Boulton D, Kornhauser D, Geraldes M, Li L, Pfister M. Dapagliflozin, a novel SGLT2 inhibitor, induces dose-dependent glucosuria in healthy subjects. Clin Pharmacol Ther. 2009 May;85(5):520-6. doi: 10.1038/clpt.2008.251. Epub 2009 Jan 7. |
| 19129749 | Background | Komoroski B, Vachharajani N, Feng Y, Li L, Kornhauser D, Pfister M. Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther. 2009 May;85(5):513-9. doi: 10.1038/clpt.2008.250. Epub 2009 Jan 7. |
| 20205482 | Background | Neumiller JJ, White JR Jr, Campbell RK. Sodium-glucose co-transport inhibitors: progress and therapeutic potential in type 2 diabetes mellitus. Drugs. 2010 Mar 5;70(4):377-85. doi: 10.2165/11318680-000000000-00000. |
| 14569097 | Background | 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. |
| Background | Sicree, R., Shaw, J., and Zimmet, P. (2010). The Global Burden - Diabetes and Impaired Glucose Tolerance (Baker IDI Heart and Diabetes Institute). |
| 12436245 | Background | 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. |
| Adverse Event |
|
| Physician Decision |
|
| Study terminated by Sponsor |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Baseline HbA1c Category | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Changes in Systolic and Diastolic Blood Pressure at Week 24 | Changes from baseline in systolic and diastolic blood pressure in placebo and treatment group after 24 weeks of treatment | Number of subjects with a value at baseline and a the specified visit | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and Week 24 |
|
|
|
|
| Secondary | Changes in Body Weight at Week 24 | Changes from baseline in body weight in placebo and treatment group after 24 weeks of treatment | Number of subjects with a value at baseline and at the specified visit | Posted | Least Squares Mean | Standard Error | kg | Baseline and week 24 |
|
|
|
|
| Secondary | Change From Baseline in HbA1c Over 96 Weeks Time | Change from baseline in HbA1c level over 96 weeks in placebo and treatment group. The treatment group was treated with EGT0001442 for 24 weeks. | Number of subjects with a value at baseline and at the specified visit | Posted | Least Squares Mean | Standard Error | percentage glycated hemoglobin | Baseline and up to 96 weeks |
|
|
|
|
| Secondary | Change From Baseline Over Time in Fasting Plasma Glucose (FPG) | Changes from baseline in FPG in placebo and treatment group over 24 weeks of treatment | Only included number of subjects with a value at baseline and at the specified visit | Posted | Least Squares Mean | Standard Error | mmol/L | 24 weeks |
|
|
|
|
| Secondary | Percentage of Subjects Achieving HbA1c <7% | The number and percentage of subjects achieving HbA1c response levels <7% for the FAS using LOCF is reported | Only included number of subjects with a value at baseline and at the specified visit | Posted | Count of Participants | Participants | Baseline and up to 96 weeks |
|
|
|
| 145 |
| 3 |
| 145 |
| 50 |
| 145 |
| EG001 | Placebo | Placebo capsule, 20 mg, orally once daily | 0 | 141 | 12 | 141 | 62 | 141 |
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Hypertensive crisis | Cardiac disorders | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | Systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Spinal column stenosis | Nervous system disorders | Systematic Assessment |
|
| Peripheral nerve lesion | Nervous system disorders | Systematic Assessment |
|
| Acute polyneuropathy | Nervous system disorders | Systematic Assessment |
|
| Lumbar spinal stenosis | Nervous system disorders | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
The PI is not allowed to publish trial results.
| ANCOVA |
Based on analysis of covariance, including treatment group, baseline diastolic BP, baseline HbA1c category, site, age category, gender and race |
| 0.0015 |
The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level. |
| Difference of LS Means |
| -2.67 |
| 2-Sided |
| 95 |
| -4.30 |
| -1.04 |
| Superiority |
| Week 12 |
|
| Week 18 |
|
| Week 24 |
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| Week 36 |
|
| Week 48 |
|
| Week 60 |
|
| Week 72 |
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| Week 84 |
|
| Week 96 |
|
| Change from baseline in HbA1c (%) at Week 6 | ANCOVA | Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race | < 0.0001 | The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level. | Difference of LS Means | -0.59 | 2-Sided | 95 | -0.78 | -0.41 | Superiority |
| Change from baseline in HbA1c (%) at Week 12 | ANCOVA | Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race | < 0.0001 | The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level. | Difference of LS Means | -0.72 | 2-Sided | 95 | -0.96 | -0.48 | Superiority |
| Change from baseline in HbA1c (%) at Week 18 | ANCOVA | Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race | < 0.0001 | The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level. | Difference of LS Means | -0.71 | 2-Sided | 95 | -0.97 | -0.44 | Superiority |
| Change from baseline in HbA1c (%) at Week 24 | ANCOVA | Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race | < 0.0001 | The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level. | Difference of LS Means | -0.79 | 2-Sided | 95 | -1.06 | -0.53 | Superiority |
| Change from baseline in HbA1c (%) at Week 36 | ANCOVA | Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race | < 0.0001 | The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level. | Difference of LS Means | -0.93 | 2-Sided | 95 | -1.21 | -0.66 | Superiority |
| Change from baseline in HbA1c (%) at Week 48 | ANCOVA | Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race | < 0.0001 | The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level | Difference of LS Means | -0.99 | 2-Sided | 95 | -1.28 | -0.70 | Superiority |
| Change from baseline in HbA1c (%) at Week 60 | ANCOVA | Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race | < 0.0001 | The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level | Difference of LS Means | -0.98 | 2-Sided | 95 | -1.27 | -0.68 | Superiority |
| Change from baseline in HbA1c (%) at Week 72 | ANCOVA | Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race | < 0.0001 | The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level | Difference of LS Means | -0.93 | 2-Sided | 95 | -1.22 | -0.64 | Superiority |
| Change from baseline in HbA1c (%) at Week 84 | ANCOVA | Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race | < 0.0001 | The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level. | Difference of LS Means | -0.98 | 2-Sided | 95 | -1.27 | -0.69 | Superiority |
| Change from baseline in HbA1c (%) at Week 96 | ANCOVA | Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race | < 0.0001 | The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level. | Difference of LS Means | -1.02 | 2-Sided | 95 | -1.31 | -0.73 | Superiority |
| Week 6 |
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| Week 12 |
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| Week 18 |
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| Week 24 |
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| Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 6, between EGT0001442 and Placebo group. | ANCOVA | Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race | < 0.0001 | The p-value is from a two-sided t-test for the difference in means of change from baseline | Difference of LS Means | -2.45 | 2-Sided | 95 | -3.09 | -1.81 | Superiority |
| Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 12, between EGT0001442 and Placebo group. | ANCOVA | Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race | < 0.0001 | The p-value is from a two-sided t-test for the difference in means of change from baseline | Difference of LS Means | -2.42 | 2-Sided | 95 | -3.06 | -1.77 | Superiority |
| Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 18, between EGT0001442 and Placebo group. | ANCOVA | Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race | < 0.0001 | The p-value is from a two-sided t-test for the difference in means of change from baseline. | Difference of LS Means | -2.71 | 2-Sided | 95 | -3.30 | -2.11 | Superiority |
| Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 24, between EGT0001442 and Placebo group. | ANCOVA | Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race | < 0.0001 | The p-value is from a two-sided t-test for the difference in means of change from baseline. | Difference of LS Means | -2.63 | 2-Sided | 95 | -3.24 | -2.02 | Superiority |
| Week 6 |
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| Week 12 |
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| Week 18 |
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| Week 24 |
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| Week 36 |
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| Week 48 |
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| Week 60 |
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| Week 72 |
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| Week 84 |
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| Week 96 |
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