Unique ID issued by UMIN | UMIN000017014 |
---|---|
Receipt number | R000019628 |
Scientific 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 |
Date of disclosure of the study information | 2015/04/01 |
Last modified on | 2016/10/11 15:30:18 |
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
A Phase 2b Study of Bexagliflozin Tablets on HbA1c in Subjects with Type 2 Diabetes Mellitus
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
A Phase 2b Study of Bexagliflozin Tablets on HbA1c in Subjects with Type 2 Diabetes Mellitus
Japan | North America |
Type 2 Diabetes Mellitus
Medicine in general |
Others
NO
Primary Objective
The primary objective of this study is to identify the optimal dose(s) through the comparison of mean HbA1c change in subjects who receive bexagliflozin tablets, 5 mg, 10 mg, 20 mg, or placebo, after 12 weeks of treatment.
Efficacy
Change in HbA1c over 12 weeks of treatment
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
4
Treatment
Medicine |
Intervention 1
After wash-out (6-10wks)and run-in period (2wks) or run-in period (2wks) only, 12wks of treatment with study drug (Placebo)
Intervention 2
After wash-out (6-10wks)and run-in period (2wks) or run-in period (2wks) only, 12wks of treatment with study drug (5mg)
Intervention 3
After wash-out (6-10wks)and run-in period (2wks) or run-in period (2wks) only, 12wks of treatment with study drug (10mg)
Intervention 4
After wash-out (6-10wks)and run-in period (2wks) or run-in period (2wks) only, 12wks of treatment with study drug (20mg)
20 | years-old | <= |
Not applicable |
Male and Female
1. Men or women =>20 years of age at screening. Women of childbearing potential must test negative by urine pregnancy test and agree to abstain from coitus or use contraception during the entire study period to avoid any possible pregnancy. Females who are surgically sterile (by reason of hysterectomy or oophorectomy) or postmenopausal (most recent menses more than 12 months prior to screening) are eligible if they test negative by urine pregnancy test.
2. Treatment naïve (i.e., have never received prescription anti-diabetic medications or have received no more than 14 days of prescription medications for diabetes in the 12 weeks prior to enrollment) or currently taking one OHA in combination with diet and exercise
3. 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. Currently having a body mass index (BMI) =< 40 kg/m2
5. Taking stable doses of medication for hypertension or hyperlipidemia as determined by adherence to a regimen that has not changed for at least 30 days prior to screening (if applicable)
6. Able to comprehend the study participation requirements and willing to provide written informed consent in accordance with institutional and regulatory guidelines
7. Able to maintain adequate glycemic control at the run-in visit (for subjects who complete the washout)
8. Having an HbA1c between 7.0 and 8.5% (inclusive) prior to randomization (day -3 to -5)
9. Capable of adhering to the investigational product administration requirements as evidenced by omission of no more than one dose of run-in medication
1.A diagnosis of type 1 diabetes mellitus or maturity onset diabetes of the young (MODY) 2.Current use of parenteral therapy for treatment of diabetes (insulin or glucagon-like peptide-1 (GLP-1) receptor agonist therapy) 3.Hemoglobinopathy or carrier status for hemoglobin alleles that affect HbA1c measurement 4.Genitourinary tract infection (e.g. urinary tract infection, vaginitis, balanitis) within 6 weeks of screening or history of =>genitourinary infections requiring treatment within 6 months of screening 5.Estimated glomerular filtration rate (eGFR), as calculated by the modification of diet in renal disease study equation (MDRD), < 60 mL/min/1.73 m2 at screening (Appendix 2) 6.Uncontrolled hypertension (average of two sitting measurements of systolic blood pressure >160 mmHg or diastolic blood pressure > 95 mmHg) at screening 7.History of New York Heart Association (NYHA) Class 4 heart failure within 3 months of screening 8.History of MI, unstable angina, stroke, or hospitalization for heart failure within 3 months of screening 9.History of treatment with an investigational drug within 30 days or within 7 half lives of the investigational drug, whichever is longer 10.Previous treatment with bexagliflozin or EGT0001474 11.Currently or within 6 months of taking any SGLT2 inhibitors from screening 12.ALT or 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 13.Exhibiting fasting plasma glucose=> 250 mg/dL (13.9 mmol/L) on two or more consecutive days prior to randomization or exhibiting 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 14.FPG =>250 mg/dL at randomization 15.Prior renal transplantation or evidence of nephrotic syndrome, defined as a urine albumin-to-creatinine ratio (UACR) > 2000 mg/g at screening
320
1st name | |
Middle name | |
Last name | Yuan-Di C.Halvorsen |
Massachusetts General Hospital
NA
55 Fruit Street,Boston,MA 02114 US
+1-617-467-4590
YHALVORSEN@CCIB.MGH.HARVARD.EDU
1st name | |
Middle name | |
Last name | Yoshitaka Ando |
Integraed Development Associates k.k
Clinical and Regulatory Operation
11F 1-11-44 Akasaka, Minato-ku, Tokyo
03-6685-5191
yoshitaka.ando@i-d-a.com
Theracos, Sub., LLC
Theracos, Sub., LLC
Profit organization
NO
2015 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2015 | Year | 02 | Month | 16 | Day |
2015 | Year | 05 | Month | 18 | Day |
2015 | Year | 04 | Month | 01 | Day |
2016 | Year | 10 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019628