PMID- 30760125
OWN - NLM
STAT- MEDLINE
DCOM- 20200609
LR  - 20200609
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 35
IP  - 8
DP  - 2019 Aug
TI  - Results of VERTIS SU extension study: safety and efficacy of ertugliflozin 
      treatment over 104 weeks compared to glimepiride in patients with type 2 diabetes 
      mellitus inadequately controlled on metformin.
PG  - 1335-1343
LID - 10.1080/03007995.2019.1583450 [doi]
AB  - Objective: To assess the safety and efficacy of ertugliflozin over 104 weeks in 
      patients with type 2 diabetes mellitus (T2DM) inadequately controlled on 
      metformin. Methods: In this double-blind, multicenter, randomized, phase III 
      study (VERTIS SU; NCT01999218), adults with T2DM and glycated hemoglobin (HbA1c) 
      7.0-9.0% on metformin >/=1500 mg/day received ertugliflozin 5 mg or 15 mg, or 
      glimepiride. The primary efficacy time point was Week 52; double-blinded 
      treatment continued until Week 104. Results: Baseline characteristics of 
      randomized, treated patients (n = 1315) were similar across groups (mean age 58.2 
      years, HbA1c 7.8%); 76.4% completed the study; 61.6% completed on study 
      medication. Mean glimepiride dose at 104 weeks was 3.5 mg/day. At Week 104, least 
      squares mean change from baseline in HbA1c (95% confidence intervals) were -0.3% 
      (-0.4, -0.2), -0.4% (-0.5, -0.3) and -0.4% (-0.5, -0.3) for ertugliflozin 5 mg, 
      15 mg, and glimepiride, respectively. Ertugliflozin provided sustained reductions 
      in body weight and systolic blood pressure (SBP) over 104 weeks. The incidence of 
      adverse events (AEs) and serious AEs was similar across groups. The incidence of 
      symptomatic hypoglycemia was 3.8%, 6.4% and 22.1% in the ertugliflozin 5 mg, 
      15 mg, and glimepiride groups, respectively. Genital mycotic infections were 
      reported in 5.3%, 2.6% and 0% of men, respectively, and 9.2%, 12.3% and 1.4% of 
      women, respectively. The incidence of urinary tract infection and hypovolemia AEs 
      was similar across groups. Conclusions: Ertugliflozin was well tolerated and 
      provided clinically meaningful glycemic control and durable reductions in body 
      weight and SBP over 104 weeks.
FAU - Hollander, Priscilla
AU  - Hollander P
AD  - a Baylor Endocrine Center , Dallas , TX , USA.
FAU - Hill, Julie
AU  - Hill J
AD  - b Merck & Co. Inc. , Kenilworth , NJ , USA.
FAU - Johnson, Jeremy
AU  - Johnson J
AD  - b Merck & Co. Inc. , Kenilworth , NJ , USA.
FAU - Wei Jiang, Zhi
AU  - Wei Jiang Z
AD  - c MSD R&D (China) Co. Ltd , Beijing , China.
FAU - Golm, Gregory
AU  - Golm G
AD  - b Merck & Co. Inc. , Kenilworth , NJ , USA.
FAU - Huyck, Susan
AU  - Huyck S
AD  - b Merck & Co. Inc. , Kenilworth , NJ , USA.
FAU - Terra, Steven G
AU  - Terra SG
AD  - d Pfizer Inc. , Andover , MA , USA.
FAU - Mancuso, James P
AU  - Mancuso JP
AD  - e Pfizer Inc. , Groton , CT , USA.
FAU - Engel, Samuel S
AU  - Engel SS
AD  - b Merck & Co. Inc. , Kenilworth , NJ , USA.
FAU - Lauring, Brett
AU  - Lauring B
AD  - f formerly of Merck & Co. Inc. , Kenilworth , NJ , USA.
AD  - g Currently at Takeda Pharmaceuticals , Cambridge , MA , USA.
FAU - Liu, Jie
AU  - Liu J
AD  - b Merck & Co. Inc. , Kenilworth , NJ , USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01999218
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20190325
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Bridged Bicyclo Compounds, Heterocyclic)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Sulfonylurea Compounds)
RN  - 6C282481IP (ertugliflozin)
RN  - 6KY687524K (glimepiride)
RN  - 9100L32L2N (Metformin)
SB  - IM
MH  - Blood Pressure
MH  - Body Weight
MH  - *Bridged Bicyclo Compounds, Heterocyclic/administration & dosage/adverse 
      effects/therapeutic use
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Female
MH  - Humans
MH  - *Hypoglycemic Agents/administration & dosage/adverse effects/therapeutic use
MH  - Male
MH  - Metformin/adverse effects/therapeutic use
MH  - Middle Aged
MH  - *Sulfonylurea Compounds/administration & dosage/adverse effects/therapeutic use
OTO - NOTNLM
OT  - Type 2 diabetes mellitus
OT  - ertugliflozin
OT  - glimepiride
OT  - glycemic control
OT  - sodium-glucose cotransporter 2 inhibitor
OT  - sulfonylurea
EDAT- 2019/02/15 06:00
MHDA- 2020/06/10 06:00
CRDT- 2019/02/15 06:00
PHST- 2019/02/15 06:00 [pubmed]
PHST- 2020/06/10 06:00 [medline]
PHST- 2019/02/15 06:00 [entrez]
AID - 10.1080/03007995.2019.1583450 [pii]
AID - 10.1080/03007995.2019.1583450 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2019 Aug;35(8):1335-1343. doi: 10.1080/03007995.2019.1583450. 
      Epub 2019 Mar 25.