A Phase 3 interventional study of placebo and taspoglutide in Diabetes Mellitus Type 2, sponsored by Hoffmann-La Roche. Completed at 71 sites in 10 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-07-28.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly) The anticipated time on study treatment is 12 months, and the target sample size is 100-500 individuals.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 305 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: placebo
Drug: taspoglutide
sc once weekly
10mg sc once weekly for 4 weeks, then 20mg sc once weekly
Absolute change from baseline in HbA1c
Time frame: 24 weeks
Change from baseline in body weight;% of patients achieving >=5% weight loss
Time frame: 24 weeks
% of patients achieving target HbA1c <=6.5%, <=7.0%; change from baseline in fasting plasma glucose; change from baseline in lipid profile; relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function
Time frame: 24 weeks
Safety:Adverse events,clinical laboratory tests, vital signs,physical examination, ECG, anti-taspoglutide antibodies\n
Time frame: At planned clinic visits, for 12 months
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche