Long-term Safety and Efficacy of Empagliflozin as Add on to GLP-1 RA

NCT02589626 | Completed Phase 4 Results

• 1 other identifier: 1245.106
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 16

Brief Summary

This is a multi-center, randomised, double-blind, parallel-group, safety and efficacy study of empagliflozin as add-on to GLP-1 RA in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment

  Percentage of patients with drug-related Adverse events (AEs) during 52 weeks of treatment are presented

  52 weeks

Secondary Outcomes (1)

• Change From Baseline in HbA1c After 52 Weeks of Treatment

  baseline and 52 weeks

Study Arms (2)

empagliflozin 10 mg

EXPERIMENTAL

empagliflozin 10 mg tablet and placebo matching empagliflozin 25 mg tablet

Drug: empagliflozin 10mg; Drug: Placebo

empagliflozin 25 mg

EXPERIMENTAL

empagliflozin 25 mg tablet and placebo matching empagliflozin 10 mg tablet

Drug: empagliflozin 25 mg; Drug: Placebo

Interventions

empagliflozin 10mg DRUG

empagliflozin 10 mg

empagliflozin 25 mg DRUG

empagliflozin 25 mg

Placebo DRUG

For blinding purposes

empagliflozin 10 mg; empagliflozin 25 mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 2 diabetes mellitus
• Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day alone for at least 10 weeks prior to screening must be \>=7.0% and \<=10.0% at screening
• Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day and one of oral antidiabetic drug (OAD) for at least 10 weeks prior to Visit 1 must be \>=7.0% and \<=9.0% at screening and \>=7.0% and \<=10.0% at placebo run-in
• Male and female patients on diet and exercise regimen who are pre-treated with OAD alone for at least 10 weeks prior to Visit 1 must be \>=7.0% and \<=10.0% at both screening and placebo run-in
• Age at informed consent must be \>=20 years
• BMI at screening must be \<=40 kg/m2

You may not qualify if:

• Uncontrolled hyperglycaemia with a glucose values \>270 mg/dL (\>15.0 mmol/L) after an overnight fast during switch/washout/placebo run-in period and confirmed by a second measurement
• Patients who are drug-naïve at screening visit or treat with any of insulin, thiazolidine dione, sodium-glucose co-transporter 2 (SGLT-2) inhibitor within 10 weeks prior to informed consent.
• Acute coronary syndrome, stroke or transient ischemic attack within 12 weeks prior to informed consent
• Indication of liver disease, defined by serum levels of either alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during screening and/or switch/washout/placebo run-in period
• Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m2 (Japanese equation) as determined during screening and/or switch/washout/placebo run-in period

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (16)

Kunisaki Makoto Clinic

Fukuoka, Fukuoka, 819-0168, Japan

Location

Seino I.M. Clinic, Fukushima, I.M.

Fukushima, Koriyama, 963-8851, Japan

Location

Nippon Kokan Fukuyama Hospital

Hiroshima, Fukuyama, 721-0927, Japan

Location

Nakakinen Clinic

Ibaraki, Naka, 311-0113, Japan

Location

Kubota Clinic

Kanagawa, Kawasaki, 214-0014, Japan

Location

Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic

Kanagawa, Yamato-shi, 242-0004, Japan

Location

Yokohama Minoru Clinic

Kanagawa, Yokohama, 232-0064, Japan

Location

Yokkaichi Diabetes Clinic

Mie, Yokkaichi, 510-0829, Japan

Location

Shiraiwa Medical Clinic

Osaka, Kashiwara-shi, 582-0005, Japan

Location

AMC Nishi-umeda Clinic

Osaka, Osaka-shi, 530-0001, Japan

Location

OCROM Clinic

Osaka, Suita, 565-0853, Japan

Location

Fukuwa Clinic

Tokyo, Chuo-ku, 103-0027, Japan

Location

Tokyo-Eki Center-building Clinic

Tokyo, Chuo-ku, 103-0027, Japan

Location

Minamino Heart Clinic

Tokyo, Hachioji, 192-0918, Japan

Location

ToCROM Clinic

Tokyo, Shinjuku-ku, 160-0022, Japan

Location

Shinjuku Research Park Clinic

Tokyo, Shinjuku-ku, 169-0073, Japan

Location

Related Publications (1)

• Terauchi Y, Utsunomiya K, Yasui A, Seki T, Cheng G, Shiki K, Lee J. Safety and Efficacy of Empagliflozin as Add-On Therapy to GLP-1 Receptor Agonist (Liraglutide) in Japanese Patients with Type 2 Diabetes Mellitus: A Randomised, Double-Blind, Parallel-Group Phase 4 Study. Diabetes Ther. 2019 Jun;10(3):951-963. doi: 10.1007/s13300-019-0604-8. Epub 2019 Mar 25.

  PMID: 30912033 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 28, 2015
• Study Start: October 29, 2015
• Primary Completion: June 2, 2017
• Study Completion: June 2, 2017
• Last Updated: January 7, 2019
• Results First Posted: January 7, 2019

Record last verified: 2019-01

Locations

JP (16)