Recent Updates
Recently added Catalysts

GW677954

Phase 2

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment448

FDA Designations

No designations recorded

Clinical trial landscape

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 X
NCT00264667290
Unlock trial analytics
PHASE2COMPLETED
Study In People With Type 2 Diabetes
Diabetes Mellitus, Type 2
NCT00196989448
Unlock 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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
GW677954DRUG -
PioglitazoneDRUG -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about GW677954

What is GW677954 used for?

GW677954 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus and Metabolic Syndrome X. It is in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being developed by GSK plc.

What does GW677954 target?

GW677954 is a small molecule being developed for metabolic conditions. Its specific molecular target has not been disclosed in available information. The drug is being studied in patients with Type 2 Diabetes and Metabolic Syndrome X, conditions related to insulin resistance and metabolic abnormalities.

Who makes GW677954?

GW677954 is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 2 clinical trials for metabolic indications, including Type 2 Diabetes Mellitus and Metabolic Syndrome X.

What phase is GW677954 in?

GW677954 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. Two Phase 2 studies have been completed, one in Type 2 Diabetes and one in Metabolic Syndrome X, with a total enrollment of 448 and 290 participants respectively.

What clinical trials is GW677954 in?

GW677954 has been studied in two completed Phase 2 clinical trials. The first, NCT00196989, enrolled 448 participants with Type 2 Diabetes across multiple countries. The second, NCT00264667, enrolled 290 participants with Metabolic Syndrome X. Both trials were randomized and double-blind, though the control type was uncontrolled.

Is GW677954 the same as another drug?

GW677954 is the primary identifier for this investigational drug. No alternative names have been reported in available clinical trial information. The drug is being developed by GSK plc and is currently in Phase 2 trials for Type 2 Diabetes Mellitus and Metabolic Syndrome X.