Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
+113 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Boehringer Ingelheim
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.
Research Team
BI
Boehringer Ingelheim
Principal Investigator
Boehringer Ingelheim
Eligibility Criteria
Inclusion Criteria
Signed and dated ICF (Informed Consent Form)
Male or female on diet and exercise regime and on stable background metformin > or equal to 1500 mg or maximun dose according to local label
HBA1c (Glicoslated Hemoglobin) > or equal to 8% and < or equal to 10.5 % at Visit 1
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Treatment Details
Interventions
- Empagliflozin (Sodium-glucose co-transporter 2 (SGLT2) Inhibitor)
- Linagliptin (Dipeptidyl Peptidase-4 (DPP-4) Inhibitor)
- Metformin (Drug)
Participant Groups
8Treatment groups
Experimental Treatment
Group I: Placebo add on 25 mg doseExperimental Treatment2 Interventions
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in
Group II: Placebo add on 10 mg doseExperimental Treatment2 Interventions
Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in
Group III: Empagliflozin/Linagliptin 25/5 mg Dose.Experimental Treatment2 Interventions
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
Group IV: Empagliflozin/Linagliptin 25/5 mg DoseExperimental Treatment2 Interventions
Empagliflozin / Linagliptin 25/5 mg Dose FDC active
Group V: Empagliflozin/Linagliptin 10/5 mg Dose.Experimental Treatment2 Interventions
Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
Group VI: Empagliflozin/Linagliptin 10/5 mg DoseExperimental Treatment2 Interventions
Empagliflozin / Linagliptin 10/5 mg Dose FDC active
Group VII: Empagliflozin 25 mg doseExperimental Treatment1 Intervention
Empagliflozin open label treatment period
Group VIII: Empagliflozin 10 mg doseExperimental Treatment1 Intervention
Empagliflozin open label treatment period
Empagliflozin is already approved in Canada, Japan for the following indications:
Approved in Canada as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
Approved in Japan as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
1275.10.01010 Boehringer Ingelheim Investigational SiteElkton, MD
1275.10.01001 Boehringer Ingelheim Investigational SiteStevensville, MI
1275.10.01007 Boehringer Ingelheim Investigational SiteSalisbury, NC
1275.10.01014 Boehringer Ingelheim Investigational SiteNorth Richland Hills, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor
Trials
2566
Patients Recruited
16,150,000+
Eli Lilly and Company
Industry Sponsor
Trials
2708
Patients Recruited
3,720,000+