Phase 4 N=129 Randomized Quadruple-blind Treatment

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

Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT04531462 ↗

Enrolled (actual)

129

Serious AEs

12.4%

Results posted

Mar 2024

Primary outcome: Primary: Change in HbA1c From Baseline After 52 Weeks of Treatment — -0.12; -0.69 percentage of glycated hemoglobin — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Empagliflozin (Drug); Placebo (Drug)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Aug 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in HbA1c From Baseline After 52 Weeks of Treatment	-0.12; -0.69	<0.0001 sig
SECONDARY Change of Muscle Mass From Baseline to Week 52	-0.96; -1.57	0.2310
SECONDARY Change of Body Fat Measurement From Baseline to Week 52	0.08; -1.77	<0.0001 sig
SECONDARY Change of Lean Body Mass From Baseline to Week 52	-1.08; -1.61	0.1632
SECONDARY Change of Total Body Water From Baseline to Week 52	-0.72; -1.35	0.0384 sig
SECONDARY Change of Bone Mineral Content From Baseline to Week 52	-0.06; -0.09	0.1975
SECONDARY Change of Skeletal Muscle Index From Baseline to Week 52	-0.245; -0.326	0.3725
SECONDARY Change of Grip Strength From Baseline to Week 52	-0.6; -0.9	0.4208
SECONDARY Change of Time in the 5-time Chair Stand Test From Baseline to Week 52	-0.9; -0.9	0.9267

Summary

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.

Eligibility Criteria

Inclusion Criteria

Japanese (defined as patient has parents who are Japanese) patients with diagnosis of Type 2 diabetes mellitus (T2DM) prior to informed consent
Glycated hemoglobin (HbA1c) ≥7.0% and ≤10.0% for patients at Visit 1 (screening). If the patient is on treatment with oral antidiabetic drug(s) potentially associated with severe hypoglycaemia (e.g., sulfonylurea or glinides), the following HbA1c value is used as criterion
HbA1c ≥7.5% and ≤10.0% for age ≥65 and 200 milligram per deciliter (mg/dL) (>11.1 millimol per Liter (mmol/L)) during run-in period
Treatment with insulin within 12 weeks prior to informed consent
Impaired cognitive ability as supported by Mini mental state examination (MMSE-J, defined as ≤23) and verified by the investigator at screening
Acute coronary syndrome (ST-elevation myocardial infarction [STEMI], non-STEMI, and unstable angina pectoris), stroke or transient ischemic attack within 12 weeks prior to informed consent
Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT = serum glutamic-pyruvic transaminase [SGPT]), aspartate aminotransferase (AST = serum glutamic-oxaloacetic transaminase[SGOT]), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN) as determined during screening and run-in period
Impaired renal function, defined as Estimated glomerular filtration rate (eGFR) <45 milliliter per minute per 1.73 square meter (mL/min/1.73 m2, severe renal impairment, Modification of Diet in Renal Disease (MDRD) formula) as determined during screening and run-in period
Low grip strength defined as <28 kilogram (kg) for male or as <18 kg for female at screening
Short length of calf circumference defined as <34 centimeter (cm) for male or 33 cm for female at screening
further exclusion criteria apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04531462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.