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Diamedica Inc Receives Phase I/II Clinical Trial Regulatory Approval For DM-199 As Potential Treatment For Diabetes


Monday, 8 Apr 2013 08:44am EDT 

Diamedica Inc announced that it has received regulatory approval to commence an anticipated 76 subject Phase I/II clinical trial for DM-199. The clinical trial, to be conducted in the Netherlands, is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of DM-199 in 36 healthy volunteers and in 40 T2D patients. Data from this trial will also support future DM-199 clinical trial regulatory filings for Type 1 and 2 diabetes and in other potential indications. The Phase I stage, a randomized, controlled trial to evaluate the safety, tolerability and pharmacokinetics of DM-199 in healthy volunteers, consists of both single ascending dose arms, and in multiple ascending dose for 14 days arms to assess the maximum tolerable dose. In the Phase II stage, T2D patients will initially be assessed for acute safety and efficacy in single ascending dose study via a meal tolerance test. A follow on 28-day dosing double-blinded placebo-controlled to assess the efficacy and safety of longer term DM-199 use. Efficacy endpoints will include measuring HbA1c, post-meal blood glucose, average blood glucose and glucose regulatory peptides levels over the 28-day study period. 

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