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LCQ908A

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Novartis AG|Last Updated: Jan 9, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment693

FDA Designations

No designations recorded

Clinical trial landscape

LCQ908A · 1 trial · 1 indication

Phase 2 1
NCT00901979A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)Type 2 Diabetes Mellitus
COMPLETED693 Analytics
PHASE2COMPLETED
A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Effect of LCQ on measures of glucose control
12 weeks

Secondary Endpoints

Changes in body weight and related measures
12 weeks
Insulin sensitivity
12 weeks
Safety and tolerability
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LCQ908 Dose 1EXPERIMENTAL -
LCQ908 Dose 2EXPERIMENTAL -
LCQ908 Dose 3EXPERIMENTAL -
LCQ908 Dose 4EXPERIMENTAL -
LCQ908 Dose 5EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
SitagliptinACTIVE_COMPARATOR -

Interventions

NameTypeDescription
LCQ908ADRUG -
PlaceboDRUG -
SitagliptinDRUG -
metforminDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites67

Inclusion Criteria: * HbA1c from 7.0-10.0%, Stable Metformin dose Exclusion Criteria: * CHF Class III-IV, Liver disease Other protocol-defined inclusion/exclusion criteria may apply

Countries:United StatesCanadaItalyPolandPuerto Rico
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Frequently asked questions about LCQ908A

What is LCQ908A used for in Type 2 Diabetes Mellitus?

LCQ908A is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus. It is in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is intended to address the metabolic condition, though its exact mechanism of action is not specified.

Who makes LCQ908A?

LCQ908A is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Type 2 Diabetes Mellitus.

What phase is LCQ908A in?

LCQ908A is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The Phase 2 trial has been completed, and the drug is not currently in active clinical trials.

What clinical trials is LCQ908A in?

LCQ908A has one completed clinical trial, identified as NCT00901979, titled 'A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)'. This Phase 2, randomized, double-blind, placebo-controlled study enrolled 693 participants across the United States, Canada, Italy, Poland, and Puerto Rico.

Is LCQ908A FDA approved?

LCQ908A is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Type 2 Diabetes Mellitus. The completed Phase 2 trial was a randomized, double-blind, placebo-controlled study, but the drug has not yet received marketing authorization from regulatory agencies.