NCT02564211

Brief Summary

This is a study to assess the safety and efficacy of the addition of ipragliflozin to sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at below P25 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

October 26, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2017

Completed
1 year until next milestone

Results Posted

Study results publicly available

March 14, 2018

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2018

Enrollment Period

1.4 years

First QC Date

September 29, 2015

Results QC Date

February 16, 2018

Last Update Submit

August 3, 2018

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)

    An AE was any unfavorable or unintended sign, symptom, or disease, and a causal relationship to the relevant investigational product is not considered. An AE could therefore be any unfavorable and unintended sign, including results from laboratory assessments, physical examination, electrocardiograms, and vital sign assessments. The percentage of participants that had AE was recorded.

    Up to 54 weeks

  • Percentage of Participants Who Had Study Drug Discontinued Due to an AE

    The percentage of participants who had study treatment stopped due to an AE regardless if they completed study.

    Up to 52 weeks

Secondary Outcomes (1)

  • Change From Baseline in HbA1c

    Baseline and Week 52

Study Arms (1)

Ipragliflozin

EXPERIMENTAL

Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy.

Drug: IpragliflozinDrug: Sitagliptin

Interventions

IpragliflozinDRUG

one 50 mg tablet QD

Ipragliflozin
SitagliptinDRUG

one 50 mg tablet QD

Ipragliflozin

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has Type 2 diabetes mellitus
  • Has inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy
  • Hemoglobin A1C (HbA1c) ≥7.0% and ≤10.0% before study participation

You may not qualify if:

  • History of type 1 diabetes mellitus or a history of ketoacidosis
  • History of any of the following medications: Thiazolidinediones (TZD) and/or insulin within 12 weeks prior to study participation, sodium glucose cotransporter 2 (SGLT2) inhibitors anytime
  • Currently has a urinary tract infection or genital infection with subjective symptom

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kaku K, Kadowaki T, Seino Y, Okamoto T, Shirakawa M, Sato A, O'Neill EA, Engel SS, Kaufman KD. Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes and inadequate glycaemic control on sitagliptin. Diabetes Obes Metab. 2021 Sep;23(9):2099-2108. doi: 10.1111/dom.14448. Epub 2021 Jun 15.

    PMID: 34033212DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ipragliflozinSitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2015

First Posted

September 30, 2015

Study Start

October 26, 2015

Primary Completion

March 7, 2017

Study Completion

March 7, 2017

Last Updated

September 4, 2018

Results First Posted

March 14, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

More information