UMIN-CTR Clinical Trial

Public 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

Acronym

A Phase 2b Study of Bexagliflozin Tablets on HbA1c in Subjects with Type 2 Diabetes Mellitus

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

Scientific Title:Acronym

A Phase 2b Study of Bexagliflozin Tablets on HbA1c in Subjects with Type 2 Diabetes Mellitus

Region

Japan

North America

Condition

Type 2 Diabetes Mellitus

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

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.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in HbA1c over 12 weeks of treatment

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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)

Interventions/Control_2

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)

Interventions/Control_3

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)

Interventions/Control_4

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)

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

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

Target sample size

320

Name of lead principal investigator

1st name
Middle name
Last name	Yuan-Di C.Halvorsen

Organization

Massachusetts General Hospital

Division name

NA

Zip code

Address

55 Fruit Street,Boston,MA 02114 US

TEL

+1-617-467-4590

Email

YHALVORSEN@CCIB.MGH.HARVARD.EDU

Name of contact person

1st name
Middle name
Last name	Yoshitaka Ando

Organization

Integraed Development Associates k.k

Division name

Clinical and Regulatory Operation

Zip code

Address

11F 1-11-44 Akasaka, Minato-ku, Tokyo

TEL

03-6685-5191

Homepage URL

Email

yoshitaka.ando@i-d-a.com

Institute

Theracos, Sub., LLC

Institute

Department

Personal name

Organization

Theracos, Sub., LLC

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2015

Year

02

Month

16

Day

Date of IRB

Anticipated trial start date

2015

Year

05

Month

18

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

04

Month

01

Day

Last modified on

2016

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019628