| Trial ID: | L2624 |
| Source ID: | NCT02794792
|
| Associated Drug: |
Ipragliflozin L-Proline
|
| Title: |
A Study to Assess the Efficacy and Safety of Ipragliflozin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin
|
| Acronym: |
IMPRESSION
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Ipragliflozin L-proline|DRUG: Metformin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c with ipragliflozin once daily added on to metformin compared to placebo added on to metformin, Glycated hemoglobin (HbA1c), Baseline and 12 weeks | Secondary: Change from baseline in HbA1c in each treatment group, Baseline and 24 weeks|Change from baseline in FPG in each treatment group, Fasting plasma glucose (FPG), Baseline, 12 weeks and 24 weeks|Number of patients reaching a treatment goal in HbA1c of < 7.0% in each treatment group, Up to 24 weeks|Change in body weight in each treatment group, Baseline, 12 weeks and 24 weeks|Change in blood pressure in each treatment group, Baseline, 12 weeks and 24 weeks|Number of patients with AEs, Adverse Events (AEs), 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, Up to 24 weeks|Percentage of patients reaching a treatment goal in HbA1c of < 7.0% in each treatment group, Up to 24 weeks|Change from baseline in PROs as measured by European Quality of Life 5 Dimensions 5 Levels [EQ-5D-5L] questionnaire, Patient-reported outcomes (PROs), Baseline, 12 weeks and 24 weeks|Change from baseline in PROs as measured by Audit of Diabetes Dependent Quality of Life [ADDQoL-19] questionnaire, Baseline, 12 weeks and 24 weeks|Change from baseline in PROs as measured by Work Productivity and Activity Impairment: General Health [WPAI:GH] questionnaire, Baseline, 12 weeks and 24 weeks|Change from baseline in PROs as measured by Diabetes Medication Satisfaction [Diab-MedSat] questionnaire, Baseline, 12 weeks and 24 weeks|Percentage of patients with AEs, 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, Up to 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Astellas Pharma Europe B.V.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
268
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-05-11
|
| Completion Date: |
2017-06-20
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-12
|
| Locations: |
Site RU70011, Moscow, 117036, Russian Federation|Site RU70005, Moscow, 119034, Russian Federation|Site RU70003, Moscow, 121374, Russian Federation|Site RU70009, Moscow, 125315, Russian Federation|Site RU70010, Nizhniy Novgorod, 603018, Russian Federation|Site RU70006, Samara, 443067, Russian Federation|Site RU70004, Saratov, 410012, Russian Federation|Site RU70008, St. Petersburg, 191119, Russian Federation|Site RU70014, St. Petersburg, 194354, Russian Federation|Site RU70007, St. Petersburg, 197022, Russian Federation|Site RU70002, St. Petersburg, 197706, Russian Federation|Site RU70015, Volgograd, 400001, Russian Federation|Site RU70001, Yaroslavl, 150003, Russian Federation|Site RU70013, Yaroslavl, 150062, Russian Federation
|
| URL: |
https://clinicaltrials.gov/show/NCT02794792
|
