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GSK716155 injections

Phase 2

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

GSK716155 injections target and mechanism

ModalitySmall molecule

Also known as GSK716155 subcutaneous injections

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment123

FDA Designations

No designations recorded

GSK716155 injections clinical trials

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 used for in type 2 diabetes?

GSK716155 is an investigational injectable medicine that was studied for the treatment of type 2 diabetes mellitus. It was evaluated in two completed clinical trials, including an injection site study and an inpatient Phase 2 study, both conducted in patients with type 2 diabetes in the United States.

Who is developing GSK716155?

GSK716155 is developed by GSK plc, which trades under the ticker GSK. The company sponsored both clinical trials of the drug in type 2 diabetes mellitus.

What phase is GSK716155 in?

GSK716155 reached Phase 2 clinical development for type 2 diabetes mellitus. It is an investigational drug and is not described as approved. Both of its registered trials are completed, and no trials are currently active.

What clinical trials is GSK716155 in?

GSK716155 was studied in two completed trials: NCT00394030, a Phase 1 injection site study in patients with type 2 diabetes and healthy volunteers, and NCT00354536, a Phase 2 inpatient study in patients with type 2 diabetes. Together they enrolled 123 participants, all in the United States.

Is GSK716155 the same as GSK716155 subcutaneous injections?

Yes. GSK716155 subcutaneous injections is another name for GSK716155, the same investigational injectable drug developed by GSK plc for type 2 diabetes mellitus. Searches using either name refer to the same asset and the same clinical trial program.

How many patients were enrolled in GSK716155 trials?

The two completed GSK716155 trials enrolled a total of 123 participants. NCT00394030 enrolled 63 patients with type 2 diabetes and healthy volunteers, and NCT00354536 enrolled 60 patients with type 2 diabetes. Both studies were controlled and randomized, and participants were 18 years or older.