A Phase 1 interventional study of RO5095932 and RO5095932 in Diabetes Mellitus Type 2, sponsored by Hoffmann-La Roche. Completed at 6 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
This randomized, double-blind, placebo-controlled study will assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO5095932 subcutaneously once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current stable doses of metformin.
9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 122 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 87 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.
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Exclusion Criteria:
Drug: RO5095932 · Drug: metformin
Drug: metformin · Drug: placebo
Drug: RO5095932 · Drug: metformin
Drug: metformin · Drug: placebo
cohorts receiving multiple ascending doses, sc once weekly for 4 weeks
dose titration to target dose, sc once weekly for 6 weeks
stable dose
sc once weekly for 4 weeks
Safety and tolerability: AEs, laboratory parameters, ECG, body weight, vital signs
Time frame: monitored throughout study, with weekly ECG and 2x weekly to 2-weekly laboratory assessments on study treatment and at intervals during follow-up
Change in hemoglobin A1c (HbA1c)
Time frame: from baseline to week 6
Pharmacokinetics: blood concentration of RO5095932 after multiple dosing
Time frame: multiple sampling weeks 1-4 or 1-6 respectively, and weekly during follow-up
Change in metabolic parameters: glucose, insulin, C-peptide
Time frame: assessed after 4 or 6 weeks on study treatment
The record gives a start of Jun 2009, a primary completion of Oct 2010 and a completion of Oct 2010. It does not say whether these dates are actual or estimated.
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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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