Category Archives: SGLT2i

Sotagliflozin T2DM renal Ph3 studies initiated by Sanofi

Two new Sanofi-sponsored clinical trial records for sotagliflozin, SOTA-CKD3 and SOTA-CKD4 have been observed. The aim of the studies is to demonstrate that sotagliflozin provides superior A1C reductions in patients with T2DM and renal impairment (stage 3 and stage 4) compared to placebo.

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Invokana CANVAS/R Demonstrates 14% RRR in 3-point MACE at ADA ’17

Results of the CV outcomes trials meta-analysis for canagliflozin, CANVAS and CANVAS-R, were published in the NEJM in conjunction with the data presentation at ADA ’17. A one-hour session reviewed background and trial design including the study population and integrated analysis methods, CV outcomes, renal outcomes, safety, and context.

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J&J Investor Event Summary

J&J hosted their pharmaceutical business review and provided commentary on the Invokana boxed warning, CANVAS/R and CREDENCE, and their pipeline dual GLP-1/glucagon agonist from Hanmi.

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Invokana Boxed Warning for Lower Limb Amputations

FDA has issued a Drug Safety Communication regarding an increased risk of lower limb amputations associated with canagliflozin therapies (Invokana, Invokamet, Invokamet XR) based on results from the CANVAS CV outcomes study. As such, FDA is requiring a Boxed Warning to be added to the labels of the respective drugs.

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Lexicon announces additional Ph3 sotagliflozin results in T1DM

Lexicon has announced additional positive data from the Ph3 inTandem1 study. Of note, a slight increase in DKA was seen in the sotagliflozin groups during the extension period with 6 cases (2.5%) on 200mg and 3 cases (1.3%) for 400mg compared to 1 patient (0.4%) on placebo.

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Lexicon Q1 ’17 Earnings Update

Lexicon hosted its Q1 earnings call and provided updates to their T1DM and T2DM diabetes development programs for sotagliflozin and LX2761.

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Lilly Q1 ’17 Earnings Update

Lilly hosted its Q1 ’17 earnings call and provided an update to its diabetes portfolio including pipeline and LCM activities.

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Lilly Initiates Ph1 for New OAD

A Lilly sponsored Ph1 ClinicaTrials.gov record has been observed for LY3325656. According to the record, the compound is dosed orally and is being compared to liraglutide and in combination with sitagliptin. MOA for LY3325656 remains to be determined.

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J&J Q1 ’17 Earnings Update

J&J presented its Q1 ’17 earnings results and provided a brief update to its diabetes business including drugs and devices. Of note, J&J is hosting its Pharmaceutical Business Review on May 17.

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