Delving into the Latest Updates on Linagliptin/Pioglitazone Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Linagliptin/pioglitazone, Pioglitazone/linagliptin

Target

DPP-4 x PPARγ

Action

inhibitors, agonists

Mechanism

DPP-4 inhibitors(Dipeptidyl peptidase IV inhibitors), PPARγ agonists(Peroxisome proliferator-activated receptor γ agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication-

Inactive Indication

Diabetes Mellitus, Type 2

Originator Organization

C.H. Boehringer Sohn AG & Co. KG

Active Organization-

Inactive Organization

Boehringer Ingelheim GmbH

License Organization-

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC19H21ClN2O3S

InChIKeyGHUUBYQTCDQWRA-UHFFFAOYSA-N

CAS Registry112529-15-4

View All Structures (2)

A Randomised, Double-blind Parallel Group Study to Compare the Efficacy and Safety of Initial Combination Therapy With Linagliptin 5 mg + Pioglitazone 15 mg, 30 mg, or 45 mg, vs. Monotherapy With Pioglitazone (15 mg, 30 mg, or 45 mg) or Linagliptin 5 mg Once Daily for 30 Weeks, Followed by a Blinded Trial Period on Linagliptin 5 mg + Pioglitazone 30 or 45 mg Versus Pioglitazone Monotherapy 30 or 45 mg or Linagliptin 5 mg for up to 54 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control on Diet and Exercise

The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and linagliptin (5 mg, administered orally once daily). In addition, durability of treatment effect and safety under chronic treatment conditions will be investigated.

Start Date01 Aug 2010

Sponsor / Collaborator

Boehringer Ingelheim GmbH

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100 Clinical Results associated with Linagliptin/Pioglitazone Hydrochloride

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100 Translational Medicine associated with Linagliptin/Pioglitazone Hydrochloride

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100 Patents (Medical) associated with Linagliptin/Pioglitazone Hydrochloride

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100 Deals associated with Linagliptin/Pioglitazone Hydrochloride

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	United States	Boehringer Ingelheim GmbH	01 Aug 2010
Diabetes Mellitus, Type 2	Phase 3	Estonia	Boehringer Ingelheim GmbH	01 Aug 2010
Diabetes Mellitus, Type 2	Phase 3	Germany	Boehringer Ingelheim GmbH	01 Aug 2010
Diabetes Mellitus, Type 2	Phase 3	Latvia	Boehringer Ingelheim GmbH	01 Aug 2010
Diabetes Mellitus, Type 2	Phase 3	Spain	Boehringer Ingelheim GmbH	01 Aug 2010
Diabetes Mellitus, Type 2	Phase 3	United Kingdom	Boehringer Ingelheim GmbH	01 Aug 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01276327 (CTgov)	Phase 1	-	64	linagliptin+pioglitazone (FDC L5P30 (Test))	vtelkjcwuz(xfjcxrjvhf) = axzvzvvclh isrvaavxng (nuakhqnzux, 20.6) View more	-	17 Apr 2014
				linagliptin+pioglitazone (L5+P30 (Ref))	vtelkjcwuz(xfjcxrjvhf) = qtwlmekmlw isrvaavxng (nuakhqnzux, 20.6) View more