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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04531462
Collaborator
(none)
129
Enrollment
18
Locations
2
Arms
22.7
Anticipated Duration (Months)
7.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
129 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomised, Double-blind, Placebo-controlled, Parallel Group, 52 Weeks Phase IV Trial to Evaluate Efficacy and Safety of Oral, Once Daily Empagliflozin in Elderly Japanese Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
Actual Study Start Date :
Oct 5, 2020
Anticipated Primary Completion Date :
Aug 19, 2022
Anticipated Study Completion Date :
Aug 26, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Empagliflozin

Drug: Empagliflozin
Empagliflozin

Placebo Comparator: Placebo

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Change in glycated hemoglobin (HbA1c) from baseline after 52 weeks of [up to 52 weeks]

    HbA1c will be measured in the units of % and mmol/mol at all clinical visits; the primary endpoint will use units of %.

Secondary Outcome Measures

  1. Change of muscle mass from baseline to Week 52 [Up to 52 weeks]

  2. Change of body fat measurement from baseline to Week 52 [Up to 52 weeks]

  3. Change of lean body mass from baseline to Week 52 [Up to 52 weeks]

  4. Change of total body water from baseline to Week 52 [Up to 52 weeks]

  5. Change of bone mineral content from baseline to Week 52 [Up to 52 weeks]

    Bone mineral content: Estimated bone mass in kilogram will be measured as a proxy for bone mineral content by bioelectrical impedance analysis (BIA). BIA is a tool for assessing body composition by passing a very small current through the body assessing differences in impedance caused by the fact that fat and lean tissues have different electrical properties.

  6. Change of skeletal muscle index from baseline to Week 52 [Up to 52 weeks]

  7. Change of grip strength from baseline to Week 52 [Up to 52 weeks]

  8. Change of time in the 5-time chair stand test from baseline to Week 52 [Up to 52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 <75

  • HbA1c ≥8.0% and ≤10.0% for age ≥75

  • Patients on diet and exercise regimen who are drug-naïve (drug-naïve is defined as no antidiabetic drugs for at least 12 weeks prior to informed consent) or on treatment with any oral antidiabetic drug (OAD) other than Glucagon-Like Peptide-1 (GLP-1) agonists and Sodium-glucose cotransporter 2 (SGLT-2) inhibitor. Antidiabetic therapy has to be unchanged for 12 weeks prior to randomisation (any thiazolidinedione therapy has to be unchanged for at least 18 weeks prior to informed consent).

  • Age ≥65 years at informed consent

  • BMI ≥22 kg/m2 at Visit 1 (screening)

  • Male or post-menopausal (a point in time 12 months after a woman's last period) female patients

  • Patient signed and dated written informed consent in accordance with International Conference on Harmonization (ICH)- Good Clinical Practice (GCP) and local legislation prior to admission to the Trial

Exclusion Criteria:
  • Uncontrolled hyperglycaemia with a fasting glucose level >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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Meitetsu HospitalAichi, NagoyaJapan451-8511
2Chubu Rosai HospitalAichi, NagoyaJapan455-8530
3Daido HospitalAichi, NagoyaJapan457-8511
4Seino Internal Medicine ClinicFukushima, KoriyamaJapan963-8851
5Gifu University HospitalGifu, GifuJapan501-1194
6Watanabe ClinicHyogo, NishinomiyaJapan662-0971
7Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika ClinicKanagawa, YokohamaJapan231-0023
8Medical Corporation KEISEIKAI Kajiyama clinicKyoto, KyotoJapan600-8898
9Medical Corporation Hayashi Katagihara ClinicKyoto, KyotoJapan615-8125
10Iryouhouijneiwakai Minamiakatsuka clinicMito, IbarakiJapan311-4153
11Moriya Keiyu HospitalMoriya, IbarakiJapan302-0118
12North Alps Medical Center Azumi HospitalNagano, Kitaazumi-gunJapan399-8695
13Asama Nanroku Komoro Medical CenterNagano, KomoroJapan384-8588
14Koshigaya Municipal HospitalSaitama, KoshigayaJapan343-8577
15Dojinkinenkai Meiwa HospitalTokyo, Chiyoda-kuJapan101-0041
16Tokyo Asbo ClinicTokyo, Chuo-kuJapan104-0031
17Shinagawa East one Medical ClinicTokyo, Minato-kuJapan108-0075
18Ikebukuro Metropolitan ClinicTokyo, Toshima-kuJapan171-0021

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT04531462
Other Study ID Numbers:
  • 1245-0218
First Posted:
Aug 28, 2020
Last Update Posted:
Oct 5, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2021