PMID- 27738482
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220409
IS  - 1918-3003 (Print)
IS  - 1918-3011 (Electronic)
IS  - 1918-3003 (Linking)
VI  - 8
IP  - 11
DP  - 2016 Nov
TI  - Comparison of Combined Tofogliflozin and Glargine, Tofogliflozin Added to 
      Insulin, and Insulin Dose-Increase Therapy in Uncontrolled Type 2 Diabetes.
PG  - 805-814
AB  - BACKGROUND: Some patients with type 2 diabetes mellitus (T2DM) on insulin have 
      poor glycemic control and require add-on therapy to reach target glucose values. 
      Increased insulin doses or the addition of an oral antidiabetic drug (OAD) may 
      improve glycemic control, but many patients fail to achieve target values. The 
      aim of this study was to compare the treatment efficacy and safety of three 
      different therapies in such patients. METHODS: T2DM outpatients with poor 
      glycemic control (HbA1c >/= 7.0%) despite insulin therapy (including patients on 
      OADs other than a sodium-glucose cotransporter 2 (SGLT2) inhibitor) were 
      included. The patients had a body mass index (BMI) of >/= 22 kg/m(2) and an 
      estimated glomerular filtration rate (eGFR) of >/= 45 mL/min/1.73 m(2), did not 
      have depletion of endogenous insulin, and had stable glucose levels for 3 months 
      before study entry on insulin therapy. Treatment was continued for 24 weeks with 
      insulin dose-increase therapy, tofogliflozin add-on therapy, or a combination of 
      insulin glargine + tofogliflozin. The primary endpoints were HbA1c, weight, and 
      total insulin dose. Secondary endpoints included fasting plasma glucose (FPG), 
      blood pressure, lipid profiles, and incidence of adverse events. RESULTS: At 
      baseline, the participants' median age was 59.0 years, mean BMI was 28.7 kg/m(2), 
      mean eGFR was 89.2 mL/min/1.73 m(2), mean HbA1c was 8.7%, and mean FPG was 174.1 
      mg/dL. The mean duration of insulin therapy was approximately 7 years. The mean 
      daily insulin dose was approximately 40 U in the three groups. Overall, 85% 
      received other background OADs in addition to insulin. Over the 24-week period, 
      HbA1c in the insulin group decreased slightly initially and then plateaued; daily 
      total insulin dose and weight increased, and blood pressure increased slightly. 
      In the insulin + tofogliflozin group and the glargine + tofogliflozin group, 
      HbA1c decreased greatly initially, and this continued over the 24-week period, 
      with HbA1c decreases of -1.0% and -0.8%, respectively; total daily insulin dose 
      (-2.6 and -12.7 U, respectively) and weight (-2.9 and -3.4 kg, respectively) 
      decreased, and blood pressure decreased slightly. Tofogliflozin therapy was well 
      tolerated. CONCLUSIONS: Tofogliflozin may offer a new option for patients whose 
      T2DM remains inadequately controlled on insulin therapy with or without 
      additional oral glucose-lowering agents.
FAU - Suzuki, Katsunori
AU  - Suzuki K
AD  - Division of Endocrinology and Metabolism, Saiseikai Niigata Daini Hospital, 
      Niigata, Japan.
FAU - Mitsuma, Yurie
AU  - Mitsuma Y
AD  - Division of Endocrinology and Metabolism, Saiseikai Niigata Daini Hospital, 
      Niigata, Japan.
FAU - Sato, Takaaki
AU  - Sato T
AD  - Division of Endocrinology and Metabolism, Saiseikai Niigata Daini Hospital, 
      Niigata, Japan.
FAU - Anraku, Takumi
AU  - Anraku T
AD  - Division of Endocrinology and Metabolism, Saiseikai Niigata Daini Hospital, 
      Niigata, Japan.
FAU - Hatta, Mariko
AU  - Hatta M
AD  - Department of Nutrition, Saiseikai Niigata Daini Hospital, Niigata, Japan.
LA  - eng
PT  - Journal Article
DEP - 20160929
PL  - Canada
TA  - J Clin Med Res
JT  - Journal of clinical medicine research
JID - 101538301
PMC - PMC5047019
OTO - NOTNLM
OT  - Glycemic control
OT  - Insulin
OT  - Insulin glargine
OT  - SGLT2 inhibitor
OT  - Tofogliflozin
OT  - Type 2 diabetes mellitus
EDAT- 2016/10/16 06:00
MHDA- 2016/10/16 06:01
PMCR- 2016/09/29
CRDT- 2016/10/15 06:00
PHST- 2016/09/21 00:00 [accepted]
PHST- 2016/10/15 06:00 [entrez]
PHST- 2016/10/16 06:00 [pubmed]
PHST- 2016/10/16 06:01 [medline]
PHST- 2016/09/29 00:00 [pmc-release]
AID - 10.14740/jocmr2741w [doi]
PST - ppublish
SO  - J Clin Med Res. 2016 Nov;8(11):805-814. doi: 10.14740/jocmr2741w. Epub 2016 Sep 
      29.