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COMPLETED Phase 1

A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of JNJ-28431754 in Patients With Type 2 Diabetes Mellitus

NCT01177163 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamic effects and pharmacokinetic characteristics of JNJ-28431754 after multiple dosing in patients with Type 2 Diabetes Mellitus who are on a stable dose of insulin.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG JNJ 28431754 300 mg/placebo
  • DRUG JNJ 28431754 100 mg/placebo

Study Locations (2)

California

  • — Chula Vista

Texas

  • — San Antonio

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2008-05
Est. Completion 2009-03
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01177163

The ClinicalTrials.gov registry entry for NCT01177163 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 18 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01177163 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01177163 about?

NCT01177163 is a clinical study titled "A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of JNJ-28431754 in Patients With Type 2 Diabetes Mellitus". The purpose of this study is to evaluate the safety, tolerability, pharmacodynamic effects and pharmacokinetic characteristics of JNJ-28431754 after multiple dosing in patients with Type 2 Diabetes Mellitus who are on a stable dose of insulin.

What is the current status of trial NCT01177163?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2008-05. Estimated completion is 2009-03.

What conditions does trial NCT01177163 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01177163?

The interventions under investigation include: Placebo (DRUG), JNJ 28431754 300 mg/placebo (DRUG), JNJ 28431754 100 mg/placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01177163?

This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 18 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01177163 being conducted?

This trial has 2 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial