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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Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Invokana CKD Outcomes Trial (CREDENCE) Primary Completion Date Delayed

The ClincalTrials.gov record for the CREDENCE trial has been updated to reflect a later primary completion date. The estimated primary completion date has been pushed back from February 11, 2019 to June 28, 2019, which may be due to trial recruitment.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.