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GSK716155 injections

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |GSK plc|Last Updated: Sep 11, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment123

FDA Designations

No designations recorded

Clinical trial landscape

GSK716155 injections · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT00354536In-patient Study With GSK716155 In Patients With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2
COMPLETED60 Analytics
PHASE2COMPLETED
In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

blood plasma levels of GSK716155
on days 2 & 9
Pharmacokinetic measurements for different injection sites after one dose.
Pre-dose, 6, 24, 48, 96, 216, 312, 480, 672 and 984 hours

Secondary Endpoints

blood plasma levels of GSK716155
on days 2 & 9
Pharmacodynamic measurements at three different times after one dose.
Up to Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
albiglutideACTIVE_COMPARATORalbiglutide injection
albiglutide placeboPLACEBO_COMPARATORplacebo injection
Group AEXPERIMENTALIn Group A healthy subjects will be randomized to receive 16 milligram (mg) of GSK716155 to abdomen.
Group BEXPERIMENTALIn Group B healthy subjects will be randomized to receive 64 mg of GSK716155 to abdomen.
Group CEXPERIMENTALIn Group C Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to abdomen.
Group DEXPERIMENTALIn Group D Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to arm.
Group EEXPERIMENTALIn Group E Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to leg.
Group FEXPERIMENTALIn Group F Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to abdomen.
Group GEXPERIMENTALIn Group G Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to arm.
Group HEXPERIMENTALIn Group H Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to leg.

Interventions

NameTypeDescription
GSK716155 subcutaneous injectionsDRUGalbiglutide subcutaneous injection
placebo injectionBIOLOGICALplacebo injection
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion criteria: * Subjects must have type 2 diabetes mellitus that has been diagnosed for at least three months. * Must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea. * Subjects must be willing to wash-out of these...

Countries:United States
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Frequently asked questions about GSK716155 injections

What is GSK716155 injections used for?

GSK716155 injections are used for the treatment of Type 2 Diabetes Mellitus. The drug is being developed by GSK plc and is currently in Phase 2 clinical development. It is an investigational small molecule being studied for its effects on blood sugar control in patients with this condition.

Who makes GSK716155?

GSK716155 is being developed by GSK plc, a global pharmaceutical 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 the treatment of Type 2 Diabetes Mellitus.

What phase is GSK716155 in?

GSK716155 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug is being evaluated for its potential use in treating Type 2 Diabetes Mellitus.

What clinical trials is GSK716155 in?

GSK716155 has been studied in two completed clinical trials. NCT00354536 was a Phase 2 in-patient study in 60 patients with Type 2 Diabetes Mellitus in the United States. NCT00394030 was a Phase 1 injection site study in 63 patients and healthy volunteers. Both trials are completed.

Is GSK716155 the same as any other drug?

No alternative names for GSK716155 have been identified. The drug is known by its development code GSK716155 and is being studied as an injection for the treatment of Type 2 Diabetes Mellitus. It is an investigational small molecule developed by GSK plc.