PMID- 37794628
OWN - NLM
STAT- MEDLINE
DCOM- 20231216
LR  - 20231216
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 26
IP  - 1
DP  - 2024 Jan
TI  - Glycaemic control, body weight, and safety of tirzepatide versus dulaglutide by 
      baseline glycated haemoglobin level in Japanese patients with type 2 diabetes: A 
      subgroup analysis of the SURPASS J-mono study.
PG  - 126-134
LID - 10.1111/dom.15296 [doi]
AB  - AIM: To evaluate glycaemic control, body weight, and safety outcomes following 
      treatment with tirzepatide or dulaglutide in patients with type 2 diabetes (T2D) 
      with a baseline haemoglobin (HbA1c) level of </=8.5% (</=69 mmol/mol) versus >8.5% 
      (>69 mmol/mol). MATERIALS AND METHODS: SURPASS J-mono was a 52-week, multicentre, 
      randomized, double-blind, parallel, active-controlled, phase 3 study conducted in 
      Japan. In this exploratory subgroup analysis of SURPASS J-mono, we examined mean 
      change in HbA1c and body weight and the incidence of adverse events (AEs) in 
      patients with a baseline HbA1c of </=8.5% versus >8.5% after treatment with 
      tirzepatide (5, 10 or 15 mg) or dulaglutide 0.75 mg. RESULTS: Of 636 randomized 
      participants, 203 had a baseline HbA1c of >8.5% and 433 had a baseline HbA1c of 
      </=8.5% (range >/=7.0% to </=10.0%). Both subgroups showed significantly greater 
      reductions in HbA1c and body weight with any-dose tirzepatide versus dulaglutide 
      0.75 mg, with greater HbA1c reductions observed in patients with a baseline HbA1c 
      of >8.5% treated with tirzepatide (least squares mean [LSM] differences of -3.13% 
      to -3.86%) or dulaglutide (LSM -1.81%) compared with patients with a baseline 
      HbA1c of </=8.5% (LSM -2.00% to -2.32%) or dulaglutide (LSM -1.05%; 
      treatment-by-baseline HbA1c subgroup interaction P </= 0.001). For the tirzepatide 
      treatment arms, LSM change from baseline in body weight ranged from -6.7 to 
      -10.7 kg for the baseline HbA1c </=8.5% subgroup and from -4.0 to -10.6 kg for the 
      baseline HbA1c >8.5% subgroup, compared with -0.6 kg and -0.4 kg, respectively, 
      for the dulaglutide arm. The incidence of hypoglycaemia was low, with no 
      substantial difference in hypoglycaemia or treatment-emergent AEs between 
      subgroups. CONCLUSIONS: Regardless of baseline HbA1c (</=8.5% or >8.5%), 
      tirzepatide at doses of 5, 10 and 15 mg is effective in Japanese patients with 
      T2D compared with dulaglutide 0.75 mg in terms of glycaemic control and body 
      weight reduction, with an adequate safety profile consistent with previous 
      reports.
CI  - (c) 2023 Eli Lilly Japan K.K and The Authors. Diabetes, Obesity and Metabolism 
      published by John Wiley & Sons Ltd.
FAU - Osonoi, Takeshi
AU  - Osonoi T
AD  - Nakakinen Clinic, Ibaraki, Japan.
FAU - Oura, Tomonori
AU  - Oura T
AUID- ORCID: 0000-0003-0872-8576
AD  - Japan Drug Development and Medical Affairs, Eli Lilly Japan K.K, Kobe, Japan.
FAU - Hirase, Tetsuaki
AU  - Hirase T
AUID- ORCID: 0000-0003-1691-8003
AD  - Japan Drug Development and Medical Affairs, Eli Lilly Japan K.K, Kobe, Japan.
LA  - eng
GR  - Eli Lilly and Company/
GR  - Mitsubishi Tanabe Pharma Corporation/
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20231004
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Glycated Hemoglobin)
RN  - 0 (Hypoglycemic Agents)
RN  - WTT295HSY5 (dulaglutide)
RN  - OYN3CCI6QE (tirzepatide)
RN  - 0 (Blood Glucose)
RN  - 0 (Immunoglobulin Fc Fragments)
RN  - 0 (Recombinant Fusion Proteins)
RN  - 62340-29-8 (Glucagon-Like Peptides)
SB  - IM
MH  - Humans
MH  - *Diabetes Mellitus, Type 2/drug therapy/chemically induced
MH  - Glycated Hemoglobin
MH  - Hypoglycemic Agents/adverse effects
MH  - Japan/epidemiology
MH  - Glycemic Control
MH  - Blood Glucose
MH  - Immunoglobulin Fc Fragments/adverse effects
MH  - Recombinant Fusion Proteins/adverse effects
MH  - *Hypoglycemia/chemically induced/epidemiology/prevention & control
MH  - Body Weight
MH  - Glucagon-Like Peptides/adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Japan
OT  - body weight
OT  - dulaglutide
OT  - glycaemic control
OT  - tirzepatide
OT  - type 2 diabetes
EDAT- 2023/10/05 06:43
MHDA- 2023/12/17 09:45
CRDT- 2023/10/05 00:43
PHST- 2023/09/06 00:00 [revised]
PHST- 2023/03/29 00:00 [received]
PHST- 2023/09/06 00:00 [accepted]
PHST- 2023/12/17 09:45 [medline]
PHST- 2023/10/05 06:43 [pubmed]
PHST- 2023/10/05 00:43 [entrez]
AID - 10.1111/dom.15296 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2024 Jan;26(1):126-134. doi: 10.1111/dom.15296. Epub 2023 
      Oct 4.