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JNJ16269110

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Johnson & Johnson|Last Updated: Jul 14, 2014

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment352

FDA Designations

No designations recorded

Clinical trial landscape

JNJ16269110 · 1 trial · 4 indications

Phase 2 1
NCT00672386A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED352 Analytics
PHASE2COMPLETED
A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Mean change in HbA1c from baseline to week 12
baseline, week 4, 6, 8, 10 and 12

Secondary Endpoints

Changes in fasting plasma glucose
every 2 weeks
Changes in body weight
every 2 weeks
Changes in plasma lipids
baseline, week 6 and 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTALJNJ16269110 5 mg twice daily for 12 weeks
002EXPERIMENTALJNJ16269110 10 mg twice daily for 12 weeks
003EXPERIMENTALJNJ16269110 15 mg twice daily for 12 weeks
004PLACEBO_COMPARATORPlacebo twice daily for 12 weeks

Interventions

NameTypeDescription
JNJ16269110DRUG5 mg twice daily for 12 weeks
PlaceboDRUGtwice daily for 12 weeks
MetforminDRUGParticipants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.
Dietary CounselingOTHERParticipants will receive dietary counseling at Screening, Week 4, 8, 12, and will be instructed to remain on a calorically appropriate diet with a maximum of 30% of calories derived from fat (in accordance with local practice guidelines for the treatment of type 2 diabetes mellitus) during the entire study.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites62

Inclusion Criteria: * History of Type 2 Diabetes Mellitus and treated with a stable dose of metformin for at least 2 months * Women must be postmenopausal or surgically incapable of childbearing or if sexually active, be practicing an effective method of birth control * BMI between 25 and 45 kg/m2 ...

Countries:BelgiumDenmarkFinlandGermanyIndiaNetherlandsNorwayPolandRussiaSwedenUnited Kingdom
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Frequently asked questions about JNJ16269110

What is JNJ16269110 used for?

JNJ16269110 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 being evaluated for its safety and effectiveness in patients with this condition.

Who makes JNJ16269110?

JNJ16269110 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the drug's potential in treating Type 2 Diabetes Mellitus.

What phase is JNJ16269110 in?

JNJ16269110 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received approval from regulatory agencies. The drug is being studied for its safety and effectiveness in patients with Type 2 Diabetes Mellitus.

What clinical trials is JNJ16269110 in?

JNJ16269110 has been studied in one completed Phase 2 clinical trial registered as NCT00672386. This randomized, double-blind, placebo-controlled study enrolled 352 participants with Type 2 Diabetes Mellitus across multiple countries including Belgium, Denmark, Finland, Germany, India, Netherlands, Norway, Poland, Russia, Sweden, and the United Kingdom.

Is JNJ16269110 FDA approved?

JNJ16269110 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Type 2 Diabetes Mellitus. The drug has completed one clinical trial, but it has not yet received regulatory approval and remains under investigation for its safety and effectiveness.