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NCT01017302 · ClinicalTrials.gov registry record · Phase 1

A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.

A Phase 1 study of Diabetes Mellitus, Type 2, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target
1
Study location

NCT01017302 is a Phase 1 study of Diabetes Mellitus, Type 2 that has completed, run by Hoffmann-La Roche. The registered enrollment target is 32 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01017302, a Phase 1 study of Diabetes Mellitus, Type 2, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target
1
Study location

Study Summary

This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type 2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the study. There will be a 5-weeks exenatide run in period and a 5-weeks period when co-administered with the study drug. RO5095932 will be administered subcutaneously as a single dose or as escalating doses. Patients will be randomized to receive either active drug or placebo in weeks 1 to 4. Active drug or placebo will be administered once weekly for 4 weeks. Patients who received active drug in weeks 1 to 4 will receive placebo in week 5. Patients who received a single dose of placebo in weeks 1 to 4, will receive a single dose of active drug in week 5. The anticipated time of study treatment is \<6 months. The target sample size is \<100 patients.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG RO5095932

Study Locations (1)

Texas

  • - San Antonio

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2009-12
Est. Completion 2011-08
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT01017302

The ClinicalTrials.gov registry entry for NCT01017302 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01017302 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT01017302 about?

NCT01017302 is a clinical study titled "A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.". This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type 2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the study. There will be a 5-weeks e...

What is the current status of trial NCT01017302?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2009-12. Estimated completion is 2011-08.

What conditions does trial NCT01017302 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.

What interventions are being tested in trial NCT01017302?

The interventions under investigation include: Placebo (DRUG), RO5095932 (DRUG).

Who is sponsoring clinical trial NCT01017302?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01017302 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.