Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGIpragliflozin
one 50 mg tablet QD
DRUGSitagliptin
one 50 mg tablet QD
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced at Least 1 Adverse Event (AE) | Up to 54 weeks | 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. |
| Percentage of Participants Who Had Study Drug Discontinued Due to an AE | Up to 52 weeks | The percentage of participants who had study treatment stopped due to an AE regardless if they completed study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c | Baseline and Week 52 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 77 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
Baseline characteristics
| Characteristic | Ipragliflozin |
|---|---|
| Age, Continuous | 58.9 years STANDARD_DEVIATION 10.5 |
| HbA1c | 8.01 Percentage STANDARD_DEVIATION 0.69 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 77 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 77 |
| other Total, other adverse events | 44 / 77 |
| serious Total, serious adverse events | 5 / 77 |
Outcome results
Primary
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.
Time frame: Up to 54 weeks
Population: All participants who received at least 1 dose of treatment period study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ipragliflozin | Percentage of Participants Who Experienced at Least 1 Adverse Event (AE) | 77.9 Percentage of participants |
Primary
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.
Time frame: Up to 52 weeks
Population: All participants who received at least 1 dose of treatment period study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ipragliflozin | Percentage of Participants Who Had Study Drug Discontinued Due to an AE | 5.2 Percentage of Participants |
Secondary
Change From Baseline in HbA1c
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ipragliflozin | Change From Baseline in HbA1c | -0.80 Percent |