A Phase 3 interventional study of Dutogliptin and Placebo in Diabetes Mellitus, Type II, sponsored by Forest Laboratories. Terminated at 147 sites in 8 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2011-09-21.
Sponsored by Forest Laboratories · Phase 3, Interventional, and Treatment
This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background therapy of glimepiride with or without metformin.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 677 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dutogliptin
Drug: Dutogliptin
Placebo
Drug: Placebo
Dutogliptin oral administration once daily on background of glimepiride with or without metformin
Placebo, oral administration once daily on background of glimepiride with or without metformin
Hemoglobin A1c (HbA1c)
Time frame: HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18), Visit 8 (Week 26).
Fasting Plasma Glucose (FPG)
Time frame: FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18), Visit 8 (Week 26).
Showing the first 100 of 147 sites across 8 countries.
This study is terminated, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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Forest Laboratories