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GW677954

Phase 4

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |GSK plc|Trials Updated: Mar 23, 2017

GW677954 development status

Highest phase Phase 4 (NCT00879970)
Phase scored for GSKPhase 2
Registered trials 107 across 39 sponsors since Jul 2004

GW677954 target and mechanism

ModalitySmall molecule

Also known as Pioglitazone

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment738

FDA Designations

No designations recorded

GW677954 clinical trials

GW677954 · 2 trials · 2 indications

Phase 2 2
NCT00264667Study In Patients With DyslipidaemiaMetabolic Syndrome X
COMPLETED290 Analytics
NCT00196989Study In People With Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED448 Analytics
PHASE2COMPLETED
Study In Patients With Dyslipidaemia
Metabolic Syndrome XUnlock trial analytics
PHASE2COMPLETED
Study In People With Type 2 Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Percentage change from baseline in non-HDL-C based on log-transformed data at week 24.
Percentage change from Baseline (Day 1) in glycated hemoglobin (HbA1c) levels at Week 16 as a measure of improvement in glucose control
Week (W) 16

Improvement in glucose control was measured by means of reduction in glycated hemoglobin (Hb) levels in blood.

Secondary Endpoints

Percentage change from baseline in lipids, in Homeostasis Model Assessment-insulin sensitivity (HOMA-S), C-Reactive Protein (CRP), Fasting Plasma Glucose (FPG), body weight and waist circumference.
Percentage change from Baseline (Day 1) in fasting HbA1c levels at Weeks 4, 8 and 12
Weeks 4, 8, and 12
Change from Baseline (Day 1) in fasting plasma glucose (FPG) at Weeks 1, 2, 4, 6, 8, 12 and 16
W1, W2, W4, W6, W8, W12, and W16
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
GW677954DRUG -
PioglitazoneDRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites50

Inclusion Criteria: * Waist circumference =102cm (men) or =88cm (women) at visit 1. * Fasting plasma HDL C =40mg/dL (1.03mmol/L) (men) or =50mg/dL (1.29mmol/L) (women) at Screening Visit 1. * Fasting TGs =150mg/dL (1.69mmol/L) and =800mg/dL (8.96mmol/L) at Screening Visit 1. * Subjects whose plasma...

Countries:ArgentinaAustraliaChileCosta RicaIndiaLatviaMexicoNew ZealandPakistanRomaniaRussiaSlovakiaSpainUnited StatesCanadaColombiaCzechiaEcuadorPeru
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Frequently asked questions about GW677954

What is GW677954 used for?

GW677954 is an investigational small molecule being studied for Metabolic Syndrome X and Type 2 Diabetes Mellitus. It has been evaluated in Phase 2 clinical trials for these metabolic conditions. The drug is not approved and remains in clinical development.

Who makes GW677954?

GW677954 is being developed by GSK plc, which trades under the ticker GSK. The company has sponsored Phase 2 clinical trials of the drug for metabolic indications including Type 2 Diabetes and Metabolic Syndrome X.

What phase is GW677954 in?

GW677954 is in Phase 2 clinical development. It has completed two Phase 2 trials, one in Type 2 Diabetes and one in Metabolic Syndrome X. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is GW677954 in?

GW677954 has completed two Phase 2 trials. NCT00196989 enrolled 448 participants with Type 2 Diabetes, and NCT00264667 enrolled 290 participants with Metabolic Syndrome X. Both trials were completed and included participants from multiple countries.

Is GW677954 the same as any other drug?

GW677954 is the primary name for this investigational drug. No alternative names have been reported for this compound in the clinical trial data. It is a small molecule being developed for metabolic conditions.