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GSK1614235

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |GSK plc|Last Updated: Jun 8, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

GSK1614235 · 1 trial · 1 indication

Phase 1 1
NCT00976261A 2-Part Trial in Subjects With Type 2 Diabetes and in Healthy Subjects to Evaluate GSK1614235, a New Glucose Lowering Drug to Treat Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED72 Analytics
PHASE1COMPLETED
A 2-Part Trial in Subjects With Type 2 Diabetes and in Healthy Subjects to Evaluate GSK1614235, a New Glucose Lowering Drug to Treat Type 2 Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Part A: Safety, tolerability parameters: adverse events, gastro-intestinal side effects, subject reported outcomes, clinical laboratory results, ECGs and vital signs
6 days
Part B: Safety, tolerability parameters: adverse events, gastro-intestinal side effects, subject reported outcomes, clinical laboratory results, ECGs and vital signs
1 day

Secondary Endpoints

Part A: Pharmacokinetics
6 days
Part A: Pharmacodynamics
6 days
Part B: Pharmacokinetics
1 day
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GSK1614235EXPERIMENTALGlucose lowering agent under investigation.
SitagliptinACTIVE_COMPARATORGlucose lowering comparator
PlaceboPLACEBO_COMPARATORPlacebo to match GSK1614235 and placebo to match Sitagliptin

Interventions

NameTypeDescription
GSK1614235DRUGGlucose lowering in Type 2 Diabetes Mellitus
SitagliptinDRUGGlucose lowering in Type 2 Diabetes Mellitus
PlaceboOTHERComparator
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Eligibility Criteria

Age Range30 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites9

Inclusion Criteria Part A: * Subjects with documented type 2 diabetes mellitus diagnosis whose HbA1c levels are \>7 and at or less than 9.5%; at screening, who are either controlled by diet alone, or are on monotherapy with oral sulfonylureas, DPP-IV inhibitors (e.g. sitagliptin), or metformin. * M...

Countries:United StatesFranceGermanyUnited Kingdom
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Frequently asked questions about GSK1614235

What is GSK1614235 used for?

GSK1614235 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is designed as a glucose lowering drug and is currently in Phase 1 clinical development. The drug is not yet approved and remains under investigation for this metabolic condition.

Who makes GSK1614235?

GSK1614235 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Type 2 Diabetes Mellitus.

What phase is GSK1614235 in?

GSK1614235 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under evaluation for the treatment of Type 2 Diabetes Mellitus.

What clinical trials is GSK1614235 in?

GSK1614235 has one completed Phase 1 clinical trial, identified as NCT00976261. This was a two-part study conducted in subjects with Type 2 Diabetes and healthy volunteers, involving 72 participants across the United States, France, Germany, and the United Kingdom. The trial was randomized, double-blind, and placebo-controlled.

Is GSK1614235 the same as a glucose lowering drug?

GSK1614235 is a new glucose lowering drug being developed to treat Type 2 Diabetes Mellitus. It is a small molecule designed to lower blood glucose levels. The drug is currently in Phase 1 clinical trials and is not yet approved for clinical use.