Trial Outcomes & Findings for Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849) (NCT NCT02564211)

Last Updated: 2018-09-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

77 participants

Primary outcome timeframe

Up to 54 weeks

Results posted on

2018-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	Ipragliflozin 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.
Overall Study STARTED	77
Overall Study COMPLETED	73
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Ipragliflozin 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.
Overall Study Adverse Event	4

Baseline Characteristics

Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ipragliflozin n=77 Participants 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.
Age, Continuous	58.9 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	77 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
HbA1c	8.01 Percentage STANDARD_DEVIATION 0.69 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 54 weeks

Population: All participants who received at least 1 dose of treatment period study medication.

Outcome measures

Outcome measures
Measure	Ipragliflozin n=77 Participants 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.
Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)	77.9 Percentage of participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: All participants who received at least 1 dose of treatment period study medication.

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

Outcome measures

Outcome measures
Measure	Ipragliflozin n=77 Participants 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.
Percentage of Participants Who Had Study Drug Discontinued Due to an AE	5.2 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: All participants who received at least 1 dose of treatment period study medication. had at least 1 measurement of the outcome variable (baseline or post-baseline) and had baseline data for those analyses that required baseline data.

Participants had HbA1c levels determined at baseline and at Week 52. HbA1c is reported as a percentage. A negative number reflects a decrease in percentage.

Outcome measures

Outcome measures
Measure	Ipragliflozin n=73 Participants 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.
Change From Baseline in HbA1c	-0.80 Percent Interval -0.96 to -0.65

Adverse Events

Ipragliflozin 50 mg

Serious events: 5 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ipragliflozin 50 mg n=77 participants at risk 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.
Cardiac disorders Angina pectoris	2.6% 2/77 • Number of events 2 • Up to 54 weeks All participants that received at least 1 dose of study drug.
Injury, poisoning and procedural complications Contusion	1.3% 1/77 • Number of events 1 • Up to 54 weeks All participants that received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	1.3% 1/77 • Number of events 1 • Up to 54 weeks All participants that received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	1.3% 1/77 • Number of events 1 • Up to 54 weeks All participants that received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Ipragliflozin 50 mg n=77 participants at risk 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.
Gastrointestinal disorders Constipation	7.8% 6/77 • Number of events 6 • Up to 54 weeks All participants that received at least 1 dose of study drug.
General disorders Thirst	10.4% 8/77 • Number of events 8 • Up to 54 weeks All participants that received at least 1 dose of study drug.
Infections and infestations Influenza	6.5% 5/77 • Number of events 5 • Up to 54 weeks All participants that received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	28.6% 22/77 • Number of events 33 • Up to 54 weeks All participants that received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	5.2% 4/77 • Number of events 4 • Up to 54 weeks All participants that received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	14.3% 11/77 • Number of events 12 • Up to 54 weeks All participants that received at least 1 dose of study drug.
Renal and urinary disorders Pollakiuria	14.3% 11/77 • Number of events 11 • Up to 54 weeks All participants that received at least 1 dose of study drug.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER