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SB756050

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |GSK plc|Last Updated: Jul 13, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

SB756050 · 1 trial · 1 indication

Phase 1 1
NCT00733577A Study to Test How SB756050 Affects Subjects With Type 2 Diabetes Mellitus After 6 Days of Dosing.Diabetes Mellitus, Type 2
COMPLETED48 Analytics
PHASE1COMPLETED
A Study to Test How SB756050 Affects Subjects With Type 2 Diabetes Mellitus After 6 Days of Dosing.
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety measures including: AEs daily; laboratory testing: day -1,2,5,7 and follow up; ECG: day -1, 2, 5, 6, 7 and follow-up; vital signs: daily; PK parameters day -1,5, and 6.
6 days of dosing

Secondary Endpoints

Pharmacodynamic endpoints will include fasting and meal or OGTT-related weighted mean AUC for glucose, GLP-1 (total and active), glucagon, insulin, PYY (active) and C-peptide levels.
6 days of dosing
Safety and tolerability parameters including adverse events, clinical laboratory, ECGs and vital signs assessments.
6 days of dosing
Subject reports of hunger and craving as reported on the Hunger and Craving questionnaire
6 days of dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTAL15 mg SB756050 or placebo
Cohort 2EXPERIMENTALPlanned dose for Cohorts 2 50mg SB756050 or placebo
Cohort 3EXPERIMENTALPlanned dose for Cohort 3 150mg SB756050 or placebo
Cohort 4EXPERIMENTALPlanned dose for Cohort 4 600mg SB756050 or placebo

Interventions

NameTypeDescription
SB756050DRUGdoses are planned to be 15mg to 600mg doses may be altered based on plasma concentrations
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Male or female subjects, 18 - 60 years of age, inclusive, at the time of signing the informed consent * A female subject is eligible to participate if she is of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or p...

Countries:United States
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Frequently asked questions about SB756050

What is SB756050 used for?

SB756050 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus. It is in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is intended to affect subjects with Type 2 diabetes, as evaluated in a completed clinical trial.

Who makes SB756050?

SB756050 is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research on this investigational drug for Type 2 Diabetes Mellitus.

What phase is SB756050 in?

SB756050 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved for commercial use. The Phase 1 trial has been completed, and the drug is no longer in active clinical testing according to available data.

What clinical trials is SB756050 in?

SB756050 has one completed clinical trial registered under NCT00733577, titled "A Study to Test How SB756050 Affects Subjects With Type 2 Diabetes Mellitus After 6 Days of Dosing." This Phase 1 study enrolled 48 participants in the United States and was a controlled, randomized trial.

Is SB756050 the same as any other drug?

No alternative names for SB756050 have been identified. The drug is known by its code name SB756050 and is being developed by GSK plc for Type 2 Diabetes Mellitus. It is a small molecule in Phase 1 clinical development.