A Phase 3 interventional study of aleglitazar+metformin and placebo+metformin in Diabetes Mellitus Type 2, sponsored by Hoffmann-La Roche. Completed at 31 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar plus metformin combination therapy compared with placebo plus metformin in patients with type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. 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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 200 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: aleglitazar+metformin
Drug: placebo+metformin
150 mcg aleglitazar given orally once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)
Oral doses of matching placebo once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)
Change from baseline in hemoglobin HbA1c
Time frame: From baseline to week 26
Change in lipid profile
Time frame: From baseline to week 26
Change from baseline in fasting plasma glucose
Time frame: From baseline to week 26
Responder rate as defined of hemoglobin HbAc1 <7.0% (<6.5%)
Time frame: From baseline to week 26
Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS)
Time frame: From baseline to week 26
Change from baseline in homeostatic index of beta cell function (HOMA-BCF)
Time frame: From baseline to week 26
Safety: incidence of adverse events
Time frame: 30 weeks (26 weeks treatment and 4 weeks follow-up)
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche