PMID- 36692230
OWN - NLM
STAT- MEDLINE
DCOM- 20230404
LR  - 20230406
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 25
IP  - 5
DP  - 2023 May
TI  - Integrated safety and efficacy analysis of dasiglucagon for the treatment of 
      severe hypoglycaemia in individuals with type 1 diabetes.
PG  - 1351-1360
LID - 10.1111/dom.14987 [doi]
AB  - AIMS: To perform an integrated analysis of the safety and efficacy of 
      dasiglucagon, a glucagon analogue available in a ready-to-use aqueous 
      formulation, to treat severe hypoglycaemia (SH) in type 1 diabetes (T1D). 
      MATERIALS AND METHODS: An integrated analysis of dasiglucagon safety was 
      conducted on data from two placebo-controlled trials (placebo-controlled pool) 
      and two placebo-controlled and four non-placebo-controlled trials (broad pool) in 
      adults with T1D. An integrated analysis of dasiglucagon efficacy was conducted of 
      pooled data and within demographic subgroups from the two placebo-controlled and 
      two non-placebo-controlled trials in adults with T1D. RESULTS: Dasiglucagon had a 
      similar safety and tolerability profile to that of reconstituted glucagon. In the 
      placebo-controlled datasets, no serious adverse events (AEs), AEs leading to 
      withdrawal from the trial, or deaths were reported. The most common causally 
      related AEs were nausea (56.5%) and vomiting (24.6%). The broad pool safety 
      analysis showed similar results. Dasiglucagon efficacy in time to plasma glucose 
      recovery from insulin-induced SH was similar to that of reconstituted glucagon 
      (median 10.0 and 12.0 minutes, respectively) and superior to placebo (median 
      40.0 minutes; P < 0.0001). The median recovery time was consistent across all 
      placebo-controlled trial subgroups. CONCLUSIONS: Dasiglucagon was well tolerated 
      and effective as a rapid rescue agent for insulin-induced SH in people with T1D.
CI  - (c) 2023 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & 
      Sons Ltd.
FAU - Heller, Simon
AU  - Heller S
AUID- ORCID: 0000-0002-2425-9565
AD  - University of Sheffield, Sheffield, UK.
FAU - Battelino, Tadej
AU  - Battelino T
AUID- ORCID: 0000-0002-0273-4732
AD  - University Medical Center Ljubljana, and Faculty of Medicine, University of 
      Ljubljana, Ljubljana, Slovenia.
FAU - Bailey, Timothy S
AU  - Bailey TS
AUID- ORCID: 0000-0003-4178-3462
AD  - AMCR Institute, Escondido, California, USA.
FAU - Pieber, Thomas R
AU  - Pieber TR
AUID- ORCID: 0000-0003-3554-0405
AD  - Medical University of Graz, Graz, Austria.
FAU - Hovelmann, Ulrike
AU  - Hovelmann U
AUID- ORCID: 0000-0002-0940-8972
AD  - Profil, Neuss, Germany.
FAU - Plum-Morschel, Leona
AU  - Plum-Morschel L
AD  - Profil, Neuss, Germany.
AD  - Profil, Mainz, Germany.
FAU - Melgaard, Anita E
AU  - Melgaard AE
AD  - Zealand Pharma A/S, Soborg, Denmark.
FAU - Aronson, Ronnie
AU  - Aronson R
AUID- ORCID: 0000-0002-8976-2321
AD  - LMC Diabetes and Endocrinology, Toronto, Ontario, Canada.
FAU - DiMeglio, Linda A
AU  - DiMeglio LA
AD  - Indiana University, Indianapolis, Indiana, USA.
FAU - Johansen, Thue
AU  - Johansen T
AD  - Zealand Pharma A/S, Soborg, Denmark.
FAU - Danne, Thomas
AU  - Danne T
AUID- ORCID: 0000-0002-8424-3944
AD  - Children's Hospital AUF DER BULT, Hannover, Germany.
LA  - eng
GR  - Zealand Pharma A/S/
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230214
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (dasiglucagon)
RN  - 9007-92-5 (Glucagon)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Blood Glucose)
RN  - 0 (Insulins)
SB  - IM
MH  - Adult
MH  - Humans
MH  - *Diabetes Mellitus, Type 1/drug therapy
MH  - Glucagon
MH  - Hypoglycemic Agents/adverse effects
MH  - Blood Glucose
MH  - *Hypoglycemia
MH  - *Insulins/adverse effects
OTO - NOTNLM
OT  - glucagon
OT  - glycaemic control
OT  - hypoglycaemia
OT  - type 1 diabetes
EDAT- 2023/01/25 06:00
MHDA- 2023/04/04 06:42
CRDT- 2023/01/24 08:42
PHST- 2023/01/20 00:00 [revised]
PHST- 2022/07/22 00:00 [received]
PHST- 2023/01/22 00:00 [accepted]
PHST- 2023/04/04 06:42 [medline]
PHST- 2023/01/25 06:00 [pubmed]
PHST- 2023/01/24 08:42 [entrez]
AID - 10.1111/dom.14987 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2023 May;25(5):1351-1360. doi: 10.1111/dom.14987. Epub 2023 
      Feb 14.