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NC-503

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |GSK plc|Last Updated: Aug 24, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

NC-503 · 2 trials · 8 indications

Phase 2 2
NCT00675857A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II DiabetesDiabetes Mellitus, Type 2
COMPLETED200 Analytics
NCT00035334Study of the Safety and Efficacy of NC-503 in Secondary (AA) AmyloidosisSecondary (AA) Amyloidosis
COMPLETED150 Analytics
PHASE2COMPLETED
A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE2COMPLETED
Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis
Secondary (AA) AmyloidosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline to Week 26 in HbA1c levels
26 weeks

Secondary Endpoints

Change in HbA1c levels
26 weeks
The rate of achieving glycemic control
26 weeks
Change in fasting serum glucose levels
26 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
APLACEBO_COMPARATOR -
BACTIVE_COMPARATOR -

Interventions

NameTypeDescription
NC-503 (eprodisate disodium)DRUGcapsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks
placeboOTHERDosage: 4 capsules BID for 26 weeks
NC-503 (Anti-amyloidotic (AA) Agent)DRUG -
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Eligibility Criteria

Age Range30 Years to 95 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Age and gender eligibility: 30 years and older * Diagnosis of Type 2 diabetes mellitus * Patients treated with a stable therapeutic dose of either metformin, a sulfonylurea agent, or metformin in combination with a sulfonylurea agent for a minimum period of 3 months prior to t...

Countries:CanadaUnited StatesFinlandFranceIsraelItalyLithuaniaNetherlandsPolandRussiaSpainTurkey (Türkiye)United Kingdom
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Frequently asked questions about NC-503

What is NC-503 used for?

NC-503 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is also being studied in patients with Metabolic Syndrome X. The drug is currently in Phase 2 clinical development and is not approved by regulatory authorities.

Who makes NC-503?

NC-503 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Type 2 Diabetes Mellitus.

What phase is NC-503 in?

NC-503 is in Phase 2 clinical development. A Phase IIa proof-of-concept study has been completed, which enrolled 200 participants with Type 2 Diabetes Mellitus. The drug is still investigational and has not received regulatory approval for any indication.

What clinical trials is NC-503 in?

NC-503 has one completed clinical trial registered under NCT00675857, titled "A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes." This was a randomized, double-blind, placebo-controlled study conducted in Canada with 200 participants aged 30 years and older.

Is NC-503 FDA approved?

NC-503 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Type 2 Diabetes Mellitus. The completed Phase IIa study was a proof-of-concept trial, and the drug has not yet progressed to later-stage trials or regulatory submission.