A Phase 3 interventional study of Placebo and taspoglutide in Diabetes Mellitus Type 2, sponsored by Hoffmann-La Roche. Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4 weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12 weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a paracetamol test at intervals during the study. The anticipated time on study treatment is 3 months, and the target sample size is \<100 individuals.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 60 is below 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: taspoglutide
Drug: taspoglutide
Drug: Placebo
sc once weekly for 12 weeks
10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks
10mg sc once weekly for 12 weeks
Tmax, log (AUC), log(Cmax)of paracetamol
Time frame: Days -1, 1, 5, 29, 33, 78 and 82
Adverse events, laboratory parameters, vital signs
Time frame: Throughout study
renal function (creatinine clearance, urine volume and electrolytes)
Time frame: Throughout study
Multiple dose pharmacokinetics of Taspoglutide
Time frame: Throughout study
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche