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NCT01691846COMPLETEDanonymous

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Plus Metformin Combination Therapy Compared With Placebo Plus Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy

Sponsor

Source record

Hoffmann-La Roche

Phase

Source record

Phase 3

Modality

AI-normalized

small molecule

Target

AI-normalized

Dual PPAR agonist (PPAR-alpha and PPAR-gamma)

Indication / condition

AI-normalized

Diabetes Mellitus Type 2

Intervention

Source record

aleglitazar+metformin, placebo+metformin

Source & freshness

Source record

NCT ID

NCT01691846

Original source

ClinicalTrials.gov

Source last updated

Feb 23, 2017

Ingested at

Jun 17, 2026

Internal sync

Jun 17, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT01691846

Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Plus Metformin Combination Therapy Compared With Placebo Plus Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy

Sponsor

Hoffmann-La Roche

Status

COMPLETED

Phase

Phase 3

Condition raw

Diabetes Mellitus Type 2

Condition normalized

Diabetes Mellitus Type 2

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Dual PPAR agonist (PPAR-alpha and PPAR-gamma)

Target normalized

Dual PPAR agonist (PPAR-alpha and PPAR-gamma)

Interventions

aleglitazar+metformin, placebo+metformin

Public preview

Source record

Aleglitazar, in combination with metformin, is being evaluated for its efficacy in patients with inadequately controlled Type 2 Diabetes Mellitus (T2D) on metformin monotherapy. The market for diabetes treatments is substantial, with a growing demand for combination therapies that enhance glycemic control and address associated metabolic issues. If successful, aleglitazar could position Hoffmann-La Roche favorably against competitors in the diabetes space, particularly those offering single-agent therapies or less effective combinations. The completion of this Phase 3 trial could facilitate regulatory approval and subsequent market entry, enhancing Roche's portfolio in diabetes management.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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