A Single Blind, (Subject and Investigator Blinded, Sponsor Unblinded), Two-Period, Placebo-Controlled, Randomized, Sequential, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DS 7309 In Subjects With Type 2 Diabetes Mellitus
Abstract
DS-7309 is being developed for the treatment of type 2 diabetes mellitus (T2DM). This will be a randomized, placebo-controlled, blinded, sequential, multiple ascending dose study to assess the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of multiple doses of DS-7309 in subjects with T2DM.
Conditions: Type 2 Diabetes Mellitus.
Primary outcome: safety and tolerability of DS-7309; determine the pharmacokinetics of DS-7309 after repeated doses; determine glycemic response.
Enrollment: 48 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 48 participants or records.
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