PMID- 31758520
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 11
IP  - 1
DP  - 2020 Jan
TI  - Once-Weekly Dulaglutide with Insulin Therapy for Type 2 Diabetes: Efficacy and 
      Safety Results from a Phase 4, Randomized, Placebo-Controlled Study.
PG  - 133-145
LID - 10.1007/s13300-019-00726-8 [doi]
AB  - INTRODUCTION: Although global studies have investigated the combination of 
      dulaglutide with insulin in patients with type 2 diabetes mellitus (T2DM), 
      differences in lean body mass and dulaglutide dosing can complicate the 
      extrapolation of global study results to Japanese patients. This phase 4, 
      randomized, placebo-controlled, double-blind, and subsequent open-label study 
      aimed to assess the efficacy and safety of once-weekly dulaglutide 0.75 mg in 
      combination with insulin therapy in patients with T2DM. METHODS: Patients 
      enrolled in this multicenter study were Japanese with T2DM who had inadequate 
      glycemic control (HbA1c 7.5-10.5%) with insulin therapy (basal insulin, premixed 
      insulin, or basal/mealtime insulin) in combination with or without one or two 
      oral antidiabetic agents (OADs). Patients were randomized in a 3:1 ratio to 
      dulaglutide or placebo. The first 16 weeks was the double-blind period with 
      stable insulin dosing, and patients taking placebo were switched to dulaglutide 
      for an additional 36-week open-label period in which all patients took 
      dulaglutide (52 weeks total). RESULTS: Patients (N = 159) were randomized to 
      dulaglutide (n = 120) or placebo (n = 39). The least-squares (LS) mean changes 
      from baseline in HbA1c at week 16 were dulaglutide - 1.45% and placebo 0.06%. The 
      LS mean and 95% confidence interval for the difference were - 1.50% (- 1.73%, 
      - 1.28%) and dulaglutide was superior to placebo. There were no significant 
      differences between treatment groups in changes from baseline in body weight and 
      insulin dose. The most frequently observed treatment-emergent adverse events in 
      dulaglutide were nasopharyngitis, constipation, abdominal discomfort, nausea, and 
      decreased appetite. The incidence rates of hypoglycemic events by week 16 were 
      dulaglutide 42.5% and placebo 30.8% (P = 0.258). CONCLUSION: Once-weekly 
      dulaglutide 0.75 mg was superior to once-weekly placebo in glycemic control 
      improvement and well tolerated in patients with T2DM in combination with insulin 
      therapy with or without OADs. TRIAL REGISTRATION: ClinicalTrials.gov, 
      NCT02750410. FUNDING: Eli Lilly and Company.
FAU - Ishii, Hitoshi
AU  - Ishii H
AD  - Department of Diabetology, Nara Medical University, Kashihara, Nara, Japan.
FAU - Onishi, Yukiko
AU  - Onishi Y
AD  - The Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan.
FAU - Oura, Tomonori
AU  - Oura T
AD  - Eli Lilly Japan K.K., Medical Development Unit-Japan, Kobe, Japan.
FAU - Takeuchi, Masakazu
AU  - Takeuchi M
AUID- ORCID: 0000-0003-3176-3118
AD  - Eli Lilly Japan K.K., Medical Development Unit-Japan, Kobe, Japan. 
      takeuchi_masakazu@yahoo.co.jp.
LA  - eng
SI  - ClinicalTrials.gov/NCT02750410
PT  - Journal Article
DEP - 20191122
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC6965529
OTO - NOTNLM
OT  - Dulaglutide
OT  - GLP-1 analog
OT  - Insulin therapy
OT  - Phase IV study
OT  - Type 2 diabetes mellitus
EDAT- 2019/11/24 06:00
MHDA- 2019/11/24 06:01
PMCR- 2019/11/22
CRDT- 2019/11/24 06:00
PHST- 2019/09/04 00:00 [received]
PHST- 2019/11/24 06:00 [pubmed]
PHST- 2019/11/24 06:01 [medline]
PHST- 2019/11/24 06:00 [entrez]
PHST- 2019/11/22 00:00 [pmc-release]
AID - 10.1007/s13300-019-00726-8 [pii]
AID - 726 [pii]
AID - 10.1007/s13300-019-00726-8 [doi]
PST - ppublish
SO  - Diabetes Ther. 2020 Jan;11(1):133-145. doi: 10.1007/s13300-019-00726-8. Epub 2019 
      Nov 22.