NCT01680978 is a Phase 2 clinical trial of aleglitazar in Diabetes Mellitus Type 2, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT01680978?

NCT01680978 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT01680978?

Interventions in NCT01680978: aleglitazar, placebo.

What condition does NCT01680978 study?

NCT01680978 studies Diabetes Mellitus Type 2.

Is NCT01680978 still recruiting?

NCT01680978 is currently completed. Last updated 1 November 2016.

Last reviewed 2016-11-01 · How we verify

NCT01680978

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

A SINGLE CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, CROSSOVER, PHASE II STUDY TO ASSESS THE EFFECT OF ALEGLITAZAR ON CARDIAC ENERGETICS AND FUNCTION IN PATIENTS WITH UNCOMPLICATED TYPE 2 DIABETES MELLITUS AND NO HISTORY OF CORONARY ARTERY DISEASE WHO ARE DRUG-NAÏVE OR TREATED WITH STABLE METFORMIN MONOTHERAPY

Completed Phase 2 Last updated 1 November 2016

What this trial tests

Phase 2 trial testing aleglitazar in Diabetes Mellitus Type 2 in 18 participants. Completed in 1 September 2013.

Timeline

1 October 2012

Primary endpoint
1 September 2013

1 September 2013

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Design	crossover
Masking	double
Enrollment	18
Start date	1 October 2012
Primary completion	1 September 2013
Estimated completion	1 September 2013
Sites	1 location across United Kingdom

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

Adults 40 to 70, 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.

Cardiac energetics: Change in PCr/ATP ratio using phosphorus magnetic resonance spectroscopy (MRS)
Time frame: from baseline to Week 6

Sponsor's own description

A single center, double-blind, placebo-controlled, randomized, crossover, phase II study to assess the effect of aleglitazar on cardiac energetics and function in patients with uncomplicated type 2 diabetes mellitus and no history of coronary artery disease who are drug-naïve or treated with stable metformin. Eligible patients will receive either 150 mcg aleglitazar or placebo orally daily for 6 weeks. After a washout period of 6 weeks, patients will cross over to the treatment not yet received.

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 NCT01680978 (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/NCT01680978.

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