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Linagliptin

Phase 3

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Jan 7, 2020

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials7
Total Enrollment9,636
FDA Designations
No designations recorded
Clinical Trials (7)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01204294Comprehensive Add on Study in JapanPHASE3 COMPLETED 574 — — Sep 1, 2010Jan 1, 2012Mar 28, 201443 Japan
NCT0118301330 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 WeeksPHASE3 COMPLETED 936 — — Aug 1, 2010Feb 1, 2013Oct 20, 2014132 United States, Estonia +4
NCT01084005Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 DiabetesPHASE3 COMPLETED 241 — — Mar 1, 2010 -Jan 29, 201434 Australia, Canada +3
NCT01087502Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal ImpairmentPHASE3 COMPLETED 241 — — Mar 1, 2010 -Jun 27, 201452 United States, Australia +7
NCT00954447Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 DiabetesPHASE3 COMPLETED 1,263 — — Aug 1, 2009 -Dec 30, 2013169 United States, Argentina +17
NCT01243424CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 DiabetesPHASE3 COMPLETED 6,103 — — Nov 11, 2010Aug 21, 2018Jan 7, 2020613 United States, Argentina +41
NCT00996658Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With PioglitazonePHASE3 COMPLETED 278 — — Oct 1, 2009 -Mar 26, 201452 United States, France +2
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Study Endpoints
Primary Endpoints
Incidence of Adverse Events (AEs)
The first drug administration through 7 days after the last drug administration, up to 382 days

The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events

Change From Baseline in HbA1c After 30 Weeks of Treatment.
Baseline and 30 weeks

HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.

HbA1c Change From Baseline to Week 24
Baseline and week 24

HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.

HbA1c Change From Baseline to Week 12
Baseline and week 12

HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c, renal function impairment and prior use of antidiabetic agents.

Change From Baseline in HbA1c After 24 Weeks
Baseline and 24 weeks

HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)

The First 3-point Major Adverse Cardiovascular Events (3P-MACE)
From randomization until individual day of trial completion, up to 432 weeks

The first occurrence of any of the following Clinical Event Committee (CEC) confirmed adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), or nonfatal stroke is presented.

Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks
baseline, 24 weeks

Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

Secondary Endpoints
Glycosylated Haemoglobin A1c (HbA1c)
Baseline and 52 weeks
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment
Baseline and 30 weeks
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment
Baseline and 30 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Bigu+LinaEXPERIMENTALbiguanide plus linagliptin
Glin+LinaEXPERIMENTALglinide plus linagliptin
Glit+LinaEXPERIMENTALglitazone plus linagliptin
SU+LinaEXPERIMENTALsulfonylurea plus linagliptin
A-GI+LinaEXPERIMENTALalpha-glucosidase inhibitor plus linagliptin
SU+MetACTIVE_COMPARATORsulfonylurea plus metformin
A-GI+MetACTIVE_COMPARATORalpha-glucosidase inhibitor plus metformin
Pioglitazone 15 mgACTIVE_COMPARATORPioglitazone Capsules 15 mg once daily
Pioglitazone 30 mgACTIVE_COMPARATORPioglitazone Capsules 30 mg once daily
Pioglitazone 45 mgACTIVE_COMPARATORPioglitazone Capsules 45 mg once daily
Linagliptin 5mgACTIVE_COMPARATORLinagliptin 5mg Tablets once daily
Linagliptin 5mg / Pioglitazone 15 mgEXPERIMENTALLinagliptin 5mg / Pioglitazone 15 mg Tablets once daily
Linagliptin 5mg / Pioglitazone 30 mgEXPERIMENTALLinagliptin 5mg / Pioglitazone 30 mg Tablets once daily
Linagliptin 5mg / Pioglitazone 45 mgEXPERIMENTALLinagliptin 5mg / Pioglitazone 45 mg Tablets once daily
linagliptinEXPERIMENTALpatients receive linagliptin 5 mg tablets once daily
placeboPLACEBO_COMPARATORpatients receive placebo tablets matching linagliptin 5 mg once daily
GlimepirideACTIVE_COMPARATORPlacebo patients switch to glimepiride after 12 weeks (40 weeks treatment)
glimepiride 1-4 mg QDACTIVE_COMPARATORpatient to receive glimepiride 1-4 mg or linagliptin placebo tablet Quaque die (QD)
Interventions
NameTypeDescription
LinagliptinDRUGLinagliptin once daily
MetforminDRUGMetformin twice or three time per day
Pioglitazone 15 mgDRUGPioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks
Pioglitazone 45 mgDRUGPioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks
Pioglitazone 30 mgDRUGPioglitazone Capsules 30 mg once daily for up to 84 weeks
Linagliptin 5mg / Pioglitazone 45 mg FDCDRUGLinagliptin 5mg low dose / Pioglitazone 30 mg Tablets once daily for 6 weeks followed by Linagliptin 5mg low dose / Pioglitazone 45 mg FDC Tablets once daily for up to 78 weeks
Linagliptin 5mg / Pioglitazone 30 mg FDCDRUGLinagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks
Linagliptin 5mgDRUGLinagliptin 5mg Tablets low dose once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
Linagliptin 5mg / Pioglitazone 15 mg FDCDRUGLinagliptin 5mg low dose / Pioglitazone 15 mg FDC Tablets once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
placeboDRUGpatients receive placebo matching linagliptin 5 mg once daily
GlimepirideDRUG1-4 mg daily after 12 weeks
linagliptin placeboDRUGlinagliptin placebo
glimepiride placeboDRUGglimepiride placebo
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites43

Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus 2. Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug Exclusion criteria: 1. Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism 2. Impaired hepatic function 3. G...

Countries:JapanUnited StatesEstoniaGermanyLatviaSpainUnited KingdomAustraliaCanadaDenmarkNetherlandsSwedenFinlandIsraelNew ZealandSlovakiaArgentinaBelgiumBrazilCzechiaGreeceItalyMexicoNorwayPeruRussiaSouth KoreaTaiwanBulgariaChileColombiaFranceGeorgiaHong KongHungaryIndiaIrelandMalaysiaPhilippinesPortugalRomaniaSerbiaSouth AfricaSwitzerlandTunisiaUkraine
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