empagliflozin medium dose - Diabetes Mellitus, Type 2 | Phase 3 | Eli Lilly and Company | BiopharmaWatch

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empagliflozin medium dose

Phase 3

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Jul 31, 2018

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

RandomizedDouble-BlindCONTROLLEDBiomarker

Total Trials3

Total Enrollment253

FDA Designations

No designations recorded

Clinical Trials (3)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT02182830	24 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus and Hypertension	PHASE3	COMPLETED	166	—	—	Jul 25, 2014	May 18, 2017	Jul 31, 2018	92	United States
NCT01947855	Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus	PHASE3	COMPLETED	60	—	—	Sep 1, 2013	Dec 1, 2013	Dec 24, 2014	2	Japan
NCT02121483	Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus	PHASE1	COMPLETED	27	—	—	Jun 1, 2014	Feb 1, 2016	Sep 19, 2016	11	United States, France +3

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Study Endpoints

Primary Endpoints

Change From Baseline in Glycated Haemoglobin (HbA1c) (%) at 24 Weeks

baseline and 24 weeks

Change from baseline in HbA1c (%) at 24 weeks is presented. The term "baseline" refers to the last observation prior to randomisation of the patient. Means presented are the adjusted means. Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) model is used in the statistical analysis.

Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment

1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28

The primary endpoint is the change in AUC1-4h for postprandial plasma glucose based on meal tolerance test from baseline after 28 days of treatment. Baseline refers to the last observation prior to administration of randomised study medication.

AUC0-inf

Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.

Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).

AUC0-tz

Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.

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

Cmax

Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.

Maximum measured concentration in plasma (Cmax).

Tmax

Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.

Maximum measured concentration in plasma (tmax).

t1/2

Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.

Terminal half-life in plasma (t1/2).

Secondary Endpoints

Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (SBP) at Week 12

baseline and 12 weeks

Changes From Baseline in Trough Mean Ambulatory SBP at Week 12

baseline and 12 weeks

Change From Baseline in Body Weight at Week 24

baseline and 24 weeks

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Study Design & Arms

AllocationRANDOMIZED

MaskingDOUBLE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Empagliflozin	EXPERIMENTAL	starting dose 10mg; forced titration after 4 weeks 25mg dose
Placebo	PLACEBO_COMPARATOR	starting dose 10mg; forced titration after 4 weeks 25mg dose
Empagliflozin low dose	EXPERIMENTAL	Empagliflozin low dose tablet once daily
Empagliflozin high dose	EXPERIMENTAL	Empagliflozin high dose tablet once daily
empagliflozin medium dose	EXPERIMENTAL	Patient to receive a medium dose of empagliflozin

Interventions

Name	Type	Description
Empagliflozin low dose	DRUG	starting dose 10mg; forced titration after 4 weeks 25mg dose
placebo	DRUG	starting dose 10mg; forced titration after 4 weeks 25mg dose
Empagliflozin high dose	DRUG	starting dose 10mg; forced titration after 4 weeks 25mg dose
Empagliflozin	DRUG	Empagliflozin low dose
empagliflozin medium dose	DRUG	-

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Eligibility Criteria

Age Range18 Years — N/A

SexALL

Healthy VolunteersNo

Study Sites92

Inclusion criteria: * Diagnosis of Type 2 Diabetes Mellitus (T2DM) prior to informed consent. * Male and female black/African American patients on diet and exercise regimen who are EITHER drug-naïve (defined as absence of any oral antidiabetic therapy, glucagon like peptide-1 (GLP-1) analog or insu...

Countries:United StatesJapanFranceIsraelMexicoSouth Africa

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