A Study to Test How Well Empagliflozin Works in Japanese People With Type 2 Diabetes Who Are Older Than 65 Years

Sponsor
Boehringer Ingelheim
Study ID
NCT04531462
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is to assess the efficacy of empagliflozin 10 mg after 52 weeks compared to placebo in elderly patients with Type 2 diabetes mellitus (T2DM) and to explore if empagliflozin has any impact on patient physical condition compared to placebo in elderly patients with T2DM.

Key Dates

Start date
Oct 5, 2020
Status verified
Apr 2024
Primary completion
Aug 19, 2022
Completion
Aug 26, 2022

Study Design

Enrollment
129 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin 10 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in HbA1c From Baseline After 52 Weeks of Treatment [ Time Frame: Change in HbA1c from baseline after 52 weeks of treatment was calculated using the MMRM model which is a longitudinal analyses and it incorporates HbA1c values from baseline and after 4 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks of treatment. ]

Related Studies