The main purpose of this study is to evaluate the efficacy in reducing glycated hemoglobin of ipragliflozin in combination with metformin compared with metformin plus placebo in subjects with type 2 diabetes mellitus who have inadequate glycemic control on metformin.
This is a phase 3, double-blind, randomized study to assess the efficacy and safety of ipragliflozin in combination with metformin compared to metformin plus placebo in subjects in Russia with type 2 diabetes mellitus who have inadequate glycemic control on metformin. Subjects will enter a 10-day (± 3 days) screening period, followed by a 2-week single-blind placebo run-in period, followed by a 24-week randomized double-blind treatment period and a 4-week follow-up period
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
268
Site RU70011
Moscow, Russia
Site RU70005
Moscow, Russia
Site RU70003
Moscow, Russia
Change from baseline in HbA1c with ipragliflozin once daily added on to metformin compared to placebo added on to metformin
Glycated hemoglobin (HbA1c)
Time frame: Baseline and 12 weeks
Change from baseline in HbA1c in each treatment group
Time frame: Baseline and 24 weeks
Change from baseline in FPG in each treatment group
Fasting plasma glucose (FPG)
Time frame: Baseline, 12 weeks and 24 weeks
Number of patients reaching a treatment goal in HbA1c of < 7.0% in each treatment group
Time frame: Up to 24 weeks
Change in body weight in each treatment group
Time frame: Baseline, 12 weeks and 24 weeks
Change in blood pressure in each treatment group
Time frame: Baseline, 12 weeks and 24 weeks
Number of patients with AEs
Adverse Events (AEs)
Time frame: Up to 24 weeks
Number of patients with AEs of special interest
AEs of special interest include: hypoglycemic events, dehydration/hypovolemia, urinary tract infections and genital infections
Time frame: Up to 24 weeks
Percentage of patients reaching a treatment goal in HbA1c of < 7.0% in each treatment group
Time frame: Up to 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site RU70009
Moscow, Russia
Site RU70010
Nizhny Novgorod, Russia
Site RU70008
Saint Petersburg, Russia
Site RU70014
Saint Petersburg, Russia
Site RU70007
Saint Petersburg, Russia
Site RU70002
Saint Petersburg, Russia
Site RU70006
Samara, Russia
...and 4 more locations
Change from baseline in PROs as measured by European Quality of Life 5 Dimensions 5 Levels [EQ-5D-5L] questionnaire
Patient-reported outcomes (PROs)
Time frame: Baseline, 12 weeks and 24 weeks
Change from baseline in PROs as measured by Audit of Diabetes Dependent Quality of Life [ADDQoL-19] questionnaire
Time frame: Baseline, 12 weeks and 24 weeks
Change from baseline in PROs as measured by Work Productivity and Activity Impairment: General Health [WPAI:GH] questionnaire
Time frame: Baseline, 12 weeks and 24 weeks
Change from baseline in PROs as measured by Diabetes Medication Satisfaction [Diab-MedSat] questionnaire
Time frame: Baseline, 12 weeks and 24 weeks
Percentage of patients with AEs
Time frame: Up to 24 weeks
Percentage of patients with AEs of special interest
AEs of special interest include: hypoglycemic events, dehydration/hypovolemia, urinary tract infections and genital infections
Time frame: Up to 24 weeks