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NCT01691989 · ClinicalTrials.gov registry record · Phase 3

A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin Therapy

A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
197
Enrollment target
20
Study locations

NCT01691989 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Hoffmann-La Roche. The registered enrollment target is 197 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT01691989, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
197 participants
Enrollment target
20
Study locations

Study Summary

This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar compared with placebo when added to a sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or sulfonylurea plus metformin therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.

Conditions Studied

Interventions

  • DRUG placebo
  • DRUG aleglitazar

Study Locations (20)

Other

  • - Buenos Aires
  • - Caba
  • - Rosario
  • - Bogotá
  • - Floridablanca

California

  • - Chino
  • - Los Angeles
  • - San Diego
  • - Santa Ana

Florida

  • - Jacksonville
  • - Kissimmee
  • - St. Petersburg

Georgia

  • - Atlanta

Indiana

  • - Avon

Maryland

  • - Bethesda

North Carolina

  • - Durham

Pennsylvania

  • - Morrisville

Trial Details

FieldValue
Enrollment Target 197 participants
Start Date 2012-12
Est. Completion 2013-09
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT01691989

The ClinicalTrials.gov registry entry for NCT01691989 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 197 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 (96% 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.

NCT01691989 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, California, Florida.

Frequently Asked Questions

What is clinical trial NCT01691989 about?

NCT01691989 is a clinical study titled "A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin Therapy". This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar compared with placebo when added to a sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with type 2 diabetes mellitus who are in...

What is the current status of trial NCT01691989?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 197 participants. The study started on 2012-12. Estimated completion is 2013-09.

What conditions does trial NCT01691989 study?

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

What interventions are being tested in trial NCT01691989?

The interventions under investigation include: placebo (DRUG), aleglitazar (DRUG).

Who is sponsoring clinical trial NCT01691989?

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

Where is trial NCT01691989 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Indiana, Maryland. 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 Editorial

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