NCT01691989 is a Phase 3 clinical trial of aleglitazar in Diabetes Mellitus Type 2, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT01691989?

NCT01691989 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT01691989?

Interventions in NCT01691989: aleglitazar, placebo.

What condition does NCT01691989 study?

NCT01691989 studies Diabetes Mellitus Type 2.

Is NCT01691989 still recruiting?

NCT01691989 is currently completed. Last updated 1 November 2016.

Last reviewed 2016-11-01 · How we verify

NCT01691989

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 1 November 2016

What this trial tests

Phase 3 trial testing aleglitazar in Diabetes Mellitus Type 2 in 197 participants. Completed in 1 September 2013.

Timeline

1 December 2012

Primary endpoint
1 September 2013

1 September 2013

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	197
Start date	1 December 2012
Primary completion	1 September 2013
Estimated completion	1 September 2013
Sites	28 locations across United States, Argentina, Colombia, Guatemala, Mexico

Drugs / interventions tested

aleglitazar — full drug profile →
placebo

Conditions studied

Diabetes Mellitus Type 2 — all drugs for Diabetes Mellitus Type 2 →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Diabetes Mellitus Type 2. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change from baseline in hemoglobin HbA1c
Time frame: From baseline to week 26

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus Type 2

Currently open trials in the same condition.

NCT07011147 — Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery · NA · recruiting
NCT07420634 — Multilevel Ecological and COM-B Determinants of Medication Adherence in Adults With Diabetes · recruiting
NCT07114822 — HOPE Intervention for Fitness · NA · recruiting
NCT07245082 — Patients With Type 2 Diabetes · recruiting
NCT07065383 — Rebalancing the Fat Content of the Heart and Muscles · NA · recruiting

Other Hoffmann-La Roche trials

Trials by the same sponsor.

NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01691989 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 1 November 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01691989.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing