Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT01691989

Public ClinicalTrials.gov record NCT01691989. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 8:55 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PHASE III STUDY TO ASSESS THE EFFICACY,SAFETY AND TOLERABILITY OF ALEGLITAZAR ADDED TO A SU OR ADDED TO A SU IN COMBINATION WITH MET IN PATIENTS WITH T2D INADEQUATELY CONTROLLED WITH SU MONOTHERAPY OR WITH SU + METFORMIN COMBINATION THERAPY

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01691989
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
197 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2012
Primary completion
Aug 31, 2013
Completion
Aug 31, 2013
Last update posted
Nov 1, 2016

2012 – 2013

United States locations

U.S. sites
15
U.S. states
10
U.S. cities
15
Facility City State ZIP Site status
Not listed Chino California 91710
Not listed Los Angeles California 90057
Not listed San Diego California 92161
Not listed Santa Ana California 92701
Not listed Jacksonville Florida 32216
Not listed Kissimmee Florida 34741
Not listed St. Petersburg Florida 33716
Not listed Atlanta Georgia 30338
Not listed Avon Indiana 46123
Not listed Bethesda Maryland 20817
Not listed Durham North Carolina 27713
Not listed Morrisville Pennsylvania 19067
Not listed Greer South Carolina 29651
Not listed Dallas Texas 75230
Not listed Richmond Virginia 23249

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01691989, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 1, 2016 · Synced Sep 5, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01691989 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →