PMID- 23906445
OWN - NLM
STAT- MEDLINE
DCOM- 20150512
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 16
IP  - 2
DP  - 2014 Feb
TI  - Dapagliflozin maintains glycaemic control while reducing weight and body fat mass 
      over 2 years in patients with type 2 diabetes mellitus inadequately controlled on 
      metformin.
PG  - 159-69
LID - 10.1111/dom.12189 [doi]
AB  - AIMS: Dapagliflozin, a highly selective inhibitor of sodium-glucose cotransporter 
      2 (SGLT2), reduces hyperglycaemia and weight in patients with type 2 diabetes 
      mellitus (T2DM) by increasing urinary glucose excretion. Long-term glycaemic 
      control, body composition and bone safety were evaluated in patients with T2DM 
      after 102 weeks of dapagliflozin treatment. METHODS: This randomized, 
      double-blind, placebo-controlled study (NCT00855166) enrolled patients with T2DM 
      [mean: age 60.7 years; HbA1c 7.2%; body mass index (BMI) 31.9 kg/m(2) ; body 
      weight 91.5 kg] inadequately controlled on metformin. Patients (N = 182) were 
      randomly assigned 1 : 1 to receive dapagliflozin 10 mg/day or placebo added to 
      open-label metformin for a 24-week double-blind treatment period followed by a 
      78-week site- and patient-blinded extension period. At week 102, changes from 
      baseline in HbA1c, weight, waist circumference, total body fat mass as measured 
      by dual-energy X-ray absorptiometry (DXA), serum markers of bone turnover, bone 
      mineral density (BMD) as measured by DXA, and adverse events were evaluated. 
      RESULTS: A total of 140 patients (76.9%) completed the study. Over 102 weeks, 
      dapagliflozin-treated patients showed reductions in HbA1c by -0.3%, weight by 
      -4.54 kg, waist circumference by -5.0 cm and fat mass by -2.80 kg without 
      increase in rate of hypoglycaemia. Compared with placebo, no meaningful changes 
      from baseline in markers of bone turnover or BMD were identified over 102 weeks. 
      One fracture occurred in each treatment group. The frequency of urinary tract 
      infection (UTI) and genital infection was similar in both treatment groups. 
      CONCLUSIONS: Over 102 weeks, dapagliflozin improved glycaemic control, and 
      reduced weight and fat mass, without affecting markers of bone turnover or BMD in 
      patients with T2DM inadequately controlled on metformin.
CI  - (c) 2013 John Wiley & Sons Ltd.
FAU - Bolinder, J
AU  - Bolinder J
AD  - Department of Endocrinology, Metabolism and Diabetes, Karolinska University 
      Hospital Huddinge, Karolinska Institute, Stockholm, Sweden.
FAU - Ljunggren, O
AU  - Ljunggren O
FAU - Johansson, L
AU  - Johansson L
FAU - Wilding, J
AU  - Wilding J
FAU - Langkilde, A M
AU  - Langkilde AM
FAU - Sjostrom, C D
AU  - Sjostrom CD
FAU - Sugg, J
AU  - Sugg J
FAU - Parikh, S
AU  - Parikh S
LA  - eng
SI  - ClinicalTrials.gov/NCT00855166
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130829
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Blood Glucose)
RN  - 0 (Glucosides)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (SLC5A2 protein, human)
RN  - 0 (Sodium-Glucose Transporter 2)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 1ULL0QJ8UC (dapagliflozin)
RN  - 9100L32L2N (Metformin)
SB  - IM
MH  - Absorptiometry, Photon
MH  - Benzhydryl Compounds/pharmacokinetics/*therapeutic use
MH  - Blood Glucose/drug effects/*metabolism
MH  - Body Mass Index
MH  - Bone Density/drug effects
MH  - Diabetes Mellitus, Type 2/blood/complications/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Glucosides/pharmacokinetics/*therapeutic use
MH  - Glycated Hemoglobin/drug effects/*metabolism
MH  - Humans
MH  - Male
MH  - Metformin/pharmacokinetics/*therapeutic use
MH  - Sodium-Glucose Transporter 2
MH  - *Sodium-Glucose Transporter 2 Inhibitors
MH  - Treatment Outcome
MH  - Weight Loss/*drug effects
OTO - NOTNLM
OT  - SGLT2 inhibitor
OT  - adipose tissue
OT  - bone mineral density
OT  - fat
OT  - metformin
OT  - randomized trial
OT  - type 2 diabetes
EDAT- 2013/08/03 06:00
MHDA- 2015/05/13 06:00
CRDT- 2013/08/03 06:00
PHST- 2013/04/24 00:00 [received]
PHST- 2013/05/26 00:00 [revised]
PHST- 2013/07/29 00:00 [accepted]
PHST- 2013/08/03 06:00 [entrez]
PHST- 2013/08/03 06:00 [pubmed]
PHST- 2015/05/13 06:00 [medline]
AID - 10.1111/dom.12189 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2014 Feb;16(2):159-69. doi: 10.1111/dom.12189. Epub 2013 Aug 
      29.