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1 Empagliflozin/2 Metformin

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Mar 9, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker

Total Trials1

Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

1 Empagliflozin/2 Metformin · 1 trial · 1 indication

Phase 1 1

NCT02106923Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) Compared With Single TabletsHealthy

COMPLETED72 Analytics

PHASE1COMPLETED

Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) Compared With Single Tablets

Healthy

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Study Endpoints

Primary Endpoints

AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point), for Empagliflozin

1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).

AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Metformin

1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point

Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Empagliflozin

1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Maximum measured concentration of empagliflozin in plasma (Cmax).

Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Metformin

1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Maximum measured concentration of metformin in plasma

Secondary Endpoints

AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Empagliflozin

1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Metformin

1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

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Study Design & Arms

AllocationRANDOMIZED

MaskingNONE

ModelCROSSOVER

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
High dose, fasted	EXPERIMENTAL	1 fixed dose combination (FDC) tablet vs 3 single tablets under fasted conditions
High dose, fed	EXPERIMENTAL	1 fixed dose combination (FDC) tablet vs 3 single tablets under fed conditions
Low dose, fasted	EXPERIMENTAL	2 fixed dose combination (FDC) tablets vs 4 single tablets under fasted conditions

Interventions

Name	Type	Description
1 tablet Empagliflozin/2 tablets Metformin XR	DRUG	Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets
10 mg Empagliflozin/1000 mg Metformin XR	DRUG	Experimental: high dose Empagliflozin/Metformin XR, FDC tablet
1 tablet 10 mg Empagliflozin/3 tablets Metformin XR	DRUG	Active Comparator: 1 x Empagliflozin/3 x Metformin XR tablets
2 tablets 5 mg Empagliflozin/750 Metformin XR	DRUG	Experimental:2 x low dose Empagliflozin/Metformin XR FDC tablets

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Eligibility Criteria

Age Range18 Years to 50 Years

SexALL

Healthy VolunteersYes

Study Sites1

Inclusion criteria: 1. Healthy males or females 2. Age 18-50 years (incl.) 3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.) 4. Subjects must be able to understand and comply with study requirements Exclusion criteria: Any deviation from healthy condition

Countries:United States

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Frequently asked questions about 1 Empagliflozin/2 Metformin

What is Empagliflozin/Metformin used for?

Empagliflozin/Metformin is a fixed-dose combination of two small molecule drugs being studied in healthy volunteers. It is currently in Phase 1 clinical development, with one completed trial that assessed the relative bioavailability of two extended-release formulations compared with single tablets.

Who makes Empagliflozin/Metformin?

Empagliflozin/Metformin is being developed by Eli Lilly and Company, which trades under the ticker LLY. The company conducted a Phase 1 clinical trial of the combination in the United States.

What phase is Empagliflozin/Metformin in?

Empagliflozin/Metformin is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The single Phase 1 trial has been completed, and the drug is not currently in any active clinical trials.

What clinical trials is Empagliflozin/Metformin in?

Empagliflozin/Metformin has one completed clinical trial, NCT02106923, titled "Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) Compared With Single Tablets." This Phase 1 study enrolled 72 healthy participants in the United States.

Is Empagliflozin/Metformin the same as Empagliflozin and Metformin taken separately?

Empagliflozin/Metformin is a fixed-dose combination of the two drugs empagliflozin and metformin. The completed clinical trial compared the relative bioavailability of two fixed-dose combination extended-release tablets against the single tablets of each component.