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)
• Enrollment: 129
• Locations: 18
• Arms: 2
• Anticipated Duration (Months): 22.7
• Patients Per Site: 7.2
• Patients Per Site Per Month: 0.3

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 Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Empagliflozin; Drug: Placebo	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
• Actual Primary Completion Date: Aug 19, 2022
• Anticipated Study Completion Date: Aug 26, 2022

Arms and Interventions

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	Meitetsu Hospital	Aichi, Nagoya		Japan	451-8511
2	Chubu Rosai Hospital	Aichi, Nagoya		Japan	455-8530
3	Daido Hospital	Aichi, Nagoya		Japan	457-8511
4	Seino Internal Medicine Clinic	Fukushima, Koriyama		Japan	963-8851
5	Gifu University Hospital	Gifu, Gifu		Japan	501-1194
6	Watanabe Clinic	Hyogo, Nishinomiya		Japan	662-0971
7	Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic	Kanagawa, Yokohama		Japan	231-0023
8	Medical Corporation KEISEIKAI Kajiyama clinic	Kyoto, Kyoto		Japan	600-8898
9	Medical Corporation Hayashi Katagihara Clinic	Kyoto, Kyoto		Japan	615-8125
10	Iryouhouijneiwakai Minamiakatsuka clinic	Mito, Ibaraki		Japan	311-4153
11	Moriya Keiyu Hospital	Moriya, Ibaraki		Japan	302-0118
12	North Alps Medical Center Azumi Hospital	Nagano, Kitaazumi-gun		Japan	399-8695
13	Asama Nanroku Komoro Medical Center	Nagano, Komoro		Japan	384-8588
14	Koshigaya Municipal Hospital	Saitama, Koshigaya		Japan	343-8577
15	Dojinkinenkai Meiwa Hospital	Tokyo, Chiyoda-ku		Japan	101-0041
16	Tokyo Asbo Clinic	Tokyo, Chuo-ku		Japan	104-0031
17	Shinagawa East one Medical Clinic	Tokyo, Minato-ku		Japan	108-0075
18	Ikebukuro Metropolitan Clinic	Tokyo, Toshima-ku		Japan	171-0021

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

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: Aug 24, 2022
• Last Verified: Aug 1, 2022

• 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: Diabetes Mellitus; Diabetes Mellitus, Type 2; Empagliflozin

Study Results

No Results Posted as of Aug 24, 2022