PMID- 26212528
OWN - NLM
STAT- MEDLINE
DCOM- 20160728
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 17
IP  - 11
DP  - 2015 Nov
TI  - Durability and tolerability of dapagliflozin over 52 weeks as add-on to metformin 
      and sulphonylurea in type 2 diabetes.
PG  - 1075-84
LID - 10.1111/dom.12543 [doi]
AB  - AIMS: To evaluate the safety and efficacy of dapagliflozin as add-on therapy to 
      metformin plus sulphonylurea over 52 weeks. METHODS: Patients with type 2 
      diabetes mellitus (T2DM) using sulphonylurea and metformin received dapagliflozin 
      10 mg/day or placebo added to therapy for 52 weeks (24-week randomized, 
      double-blind period plus 28-week double-blind extension). RESULTS: A total of 219 
      patients were randomized 1 : 1 to dapagliflozin or placebo. Over 52 weeks, 
      glycated haemoglobin (HbA1c) and fasting plasma glucose levels showed greater 
      improvement from baseline with dapagliflozin (-0.8% and -1.5 mmol/l) than with 
      placebo (-0.1% and 0.6 mmol/l). More patients achieved HbA1c <7.0% with 
      dapagliflozin (27.3%) than with placebo (11.3%) at 52 weeks. Dapagliflozin was 
      associated with greater reductions in body weight and systolic blood pressure 
      (-2.9 kg and -1.0 mmHg) compared with placebo (-1.0 kg and 1.1 mmHg). Greater 
      increases in total, LDL and HDL cholesterol and decreases in triglycerides were 
      observed with dapagliflozin (3.4, 4.8, 6.9 and -8.0%, respectively) versus 
      placebo (1.4, 0.9, 0.6 and 2.9%, respectively). Fewer patients were rescued for 
      failing to reach glycaemic targets with dapagliflozin (9.3%) than with placebo 
      (44.4%). Adverse events and serious adverse events were similar between groups 
      (dapagliflozin: 69.7 and 6.4%; placebo: 73.4 and 7.3%). More hypoglycaemic events 
      were observed with dapagliflozin (15.6%) than with placebo (8.3%). Genital 
      infections were reported in more patients in the dapagliflozin (10.1%) than in 
      the placebo group (0.9%) and urinary tract infection frequency was similar in the 
      two groups (10.1 and 11.0%). CONCLUSION: Dapagliflozin as add-on to metformin 
      plus a sulphonylurea was well tolerated and improvement in glycaemic control was 
      maintained over 52 weeks.
CI  - (c) 2015 John Wiley & Sons Ltd.
FAU - Matthaei, S
AU  - Matthaei S
AD  - Diabetes-Zentrum Quakenbruck, Quakenbruck, Germany.
FAU - Bowering, K
AU  - Bowering K
AD  - University of Alberta, Department of Medicine, Alberta, Canada.
FAU - Rohwedder, K
AU  - Rohwedder K
AD  - AstraZeneca, Wedel, Germany.
FAU - Sugg, J
AU  - Sugg J
AD  - Formerly AstraZeneca, Wilmington, DE, USA.
FAU - Parikh, S
AU  - Parikh S
AD  - AstraZeneca, Gaithersburg, MD, USA.
FAU - Johnsson, E
AU  - Johnsson E
AD  - AstraZeneca, Molndal, Sweden.
CN  - Study 05 Group
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150904
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 (Hypoglycemic Agents)
RN  - 0 (Sulfonylurea Compounds)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 1ULL0QJ8UC (dapagliflozin)
RN  - 9100L32L2N (Metformin)
RN  - 97C5T2UQ7J (Cholesterol)
SB  - IM
MH  - Aged
MH  - Benzhydryl Compounds/*administration & dosage/adverse effects
MH  - Blood Glucose/drug effects
MH  - Blood Pressure/drug effects
MH  - Body Weight/drug effects
MH  - Cholesterol/blood
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Fasting/blood
MH  - Female
MH  - Glucosides/*administration & dosage/adverse effects
MH  - Glycated Hemoglobin/drug effects
MH  - Humans
MH  - Hypoglycemia/chemically induced
MH  - Hypoglycemic Agents/*administration & dosage/adverse effects
MH  - Male
MH  - Metformin/*administration & dosage
MH  - Middle Aged
MH  - Sulfonylurea Compounds/*administration & dosage
MH  - Urinary Tract Infections/chemically induced
OTO - NOTNLM
OT  - SGLT2 inhibitor
OT  - dapagliflozin
OT  - metformin
OT  - sulphonylureas
EDAT- 2015/07/28 06:00
MHDA- 2016/07/29 06:00
CRDT- 2015/07/28 06:00
PHST- 2015/03/06 00:00 [received]
PHST- 2015/07/13 00:00 [revised]
PHST- 2015/07/16 00:00 [accepted]
PHST- 2015/07/28 06:00 [entrez]
PHST- 2015/07/28 06:00 [pubmed]
PHST- 2016/07/29 06:00 [medline]
AID - 10.1111/dom.12543 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2015 Nov;17(11):1075-84. doi: 10.1111/dom.12543. Epub 2015 
      Sep 4.