2019 Post-ADA Report
2019 Post-ADA Report
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Author: Biomedtracker
Publisher: Datamonitor Healthcare
- Highlights
- Description
- Contents
- Trulicity’s REWIND had the most new data and was the first glucagon-like peptide-1 (GLP-1) agonist CVOTto show a benefit in primary prevention patients, though key opinion leaders (KOLs) felt this was due tothe trial design, and overall the results were fairly modest. The data of course feed into the competitionbetween Eli Lilly and Novo Nordisk on GLP-1 agonists and co-agonists, which was a major topic of interestat the conference, as they seek to top each other with higher doses and novel approaches that will winout on glycated hemoglobin (A1C) reduction and weight loss, without compromising too much ontolerability.
- With the strong evidence for a renal benefit with sodium-glucose cotransporter-2 (SGLT-2) inhibitors, ashighlighted in presentations on Invokana’s CREDENCE and analyses from Farxiga’s DECLARE, a battle isalso brewing between these agents and the GLP-1 agonists in the diabetic nephropathy (DN) segment,where their CV benefits are also important. Trulicity showed interesting evidence of a strong renal benefitin an updated analysis from AWARD-7 (Eli Lilly, though, also markets the SGLT-2 inhibitor Jardiance), andat its investor call, Novo Nordisk highlighted its FLOW cardiorenal outcomes trial for Ozempic, which hadbeen announced earlier in the year, with plans to bridge the data to oral semaglutide. FLOW only startedto enroll just after the conference, however, and will take some years to complete.
- The major review of oral semaglutide’s Phase III program, taking a full session at the conference,manifested how the drug is poised to disrupt the field of branded oral drugs, though many details werealready known from prior releases of data.
Overview
The American Diabetes Association (ADA) 79th Scientific Sessions was held in San Francisco, CA from 7–11 June 2019. This year’s conference was filled with major sessions dedicated to outcomes trials and Phase III programs, notably: first details from Trulicity’s REWIND (LLY, Sumitomo Dainippon) cardiovascular outcomes trial (CVOT), first conference presentation of oral semaglutide’s (NVO, EMIS) PIONEER 6 CV safety study and other trials from its Phase III program, first ADA presentation of Invokana’s (JNJ, Mitsubishi Tanabe, Daiichi Sankyo) CREDENCE cardiorenal outcomes trial, an update with new CV and renal details from Farxiga’s (AZN, Ono) DECLARE-TIMI 58 CVOT, first details from Tradjenta’s (Boehringer, LLY) CAROLINA CVOT trial against glimepiride, and first ADA presentation of Tradjenta’s CARMELINA CVOT against placebo.
Contents
Selected Abstracts Featured at the American Diabetes Association 79th Scientific Sessions…………..13
GLP-1 Agonists……………………………………………………………………………………………………………………….13
Trulicity (LLY, Sumitomo Dainippon; NDA Cardiovascular Disease)……………………………………………….13
Trulicity (LLY, Sumitomo Dainippon; Approved Type 2)………………………………………………………………24
Oral Semaglutide (NVO, EMIS; NDA Type 2)……………………………………………………………………………..25
GLP-1 Co-Agonists ………………………………………………………………………………………………………………….34
LY3298176 (LLY; Phase III Type 2) …………………………………………………………………………………………..34
Other GLP-1 Co-Agonists News……………………………………………………………………………………………..37
SGLT Inhibitors ………………………………………………………………………………………………………………………38
Invokana (JNJ, Mitsubishi Tanabe, Daiichi Sankyo; NDA Diabetic Nephropathy)……………………………..38
Other SGLT Inhibitor News……………………………………………………………………………………………………47
DPP-IV Inhibitors……………………………………………………………………………………………………………………48
Tradjenta (Boehringer, LLY; Approved Type 2) ………………………………………………………………………….48
Insulins………………………………………………………………………………………………………………………………….51
LY900014 (LLY; Phase III Type 1 and Type 2) …………………………………………………………………………….51
Dance 501 (Dance; Phase II Type 2) ………………………………………………………………………………………..55
Afrezza (MNKD; Approved Type 1)………………………………………………………………………………………….57
Afrezza (MNKD; Approved Type 2)………………………………………………………………………………………….58
SAR341402 (SNY; Phase III Type 1)………………………………………………………………………………………….59
SAR341402 (SNY; Phase III Type 1)………………………………………………………………………………………….61
SAR341402 (SNY; Phase III Type 1)………………………………………………………………………………………….62
Other Insulin News………………………………………………………………………………………………………………63
Prevention of Type 1 Diabetes…………………………………………………………………………………………………64
PRV-031 (teplizumab; PRVB, MGNX; Phase III Type 1)………………………………………………………………..64
Non-Alcoholic Steatohepatitis (NASH)……………………………………………………………………………………..69
MSDC-0602K (Cirius Therapeutics; Phase II NASH)…………………………………………………………………….69
LY3298176 (LLY; Phase I NASH)………………………………………………………………………………………………72
MK-3655 (formerly NGM313; MRK, NGM; Phase I NASH)…………………………………………………………..74
Other NASH News ……………………………………………………………………………………………………………….81
Notes on Dyslipidemia ……………………………………………………………………………………………………………81
Vascepa (AMRN; Approved Hypertriglyceridemia, NDA Cardiovascular Disease) ……………………………81
Apheresis and PCSK9 inhibitors………………………………………………………………………………………………83
Other Mechanisms…………………………………………………………………………………………………………………83
Other Mechanisms News ……………………………………………………………………………………………………..83
Devices………………………………………………………………………………………………………………………………….85
Artificial Pancreas System – Tandem (TNDM, DXCM; Approved Type I) ………………………………………..85
Artificial Pancreas System – Tandem (TNDM, DXCM; Approved Type I) ………………………………………..88
MiniMed 780G (MDT; Development Type 1)…………………………………………………………………………….89
MiniMed 670G (MDT; Approved Type 1) …………………………………………………………………………………90
FreeStyle Libre Flash Glucose Monitoring System (ABT; Approved Type 2)……………………………………91
Other Device News………………………………………………………………………………………………………………94
List of Biomedtracker and Meddevicetracker ADA 2019 Events……………………………………………………….95
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