PMID- 25633662
OWN - NLM
STAT- MEDLINE
DCOM- 20150909
LR  - 20221207
IS  - 1935-5548 (Electronic)
IS  - 0149-5992 (Linking)
VI  - 38
IP  - 3
DP  - 2015 Mar
TI  - Initial combination of empagliflozin and linagliptin in subjects with type 2 
      diabetes.
PG  - 394-402
LID - 10.2337/dc14-2365 [doi]
AB  - OBJECTIVE: To evaluate the efficacy and safety of empagliflozin/linagliptin in 
      subjects with type 2 diabetes. RESEARCH DESIGN AND METHODS: Subjects not 
      receiving antidiabetes therapy for >/=12 weeks were randomized to empagliflozin 25 
      mg/linagliptin 5 mg (n = 137), empagliflozin 10 mg/linagliptin 5 mg (n = 136), 
      empagliflozin 25 mg (n = 135), empagliflozin 10 mg (n = 134), or linagliptin 5 mg 
      (n = 135) for 52 weeks. The primary end point was change from baseline in HbA1c 
      at week 24. RESULTS: Mean HbA1c at baseline was 7.99-8.05% (64 mmol/mol). At week 
      24, adjusted mean (SE) changes from baseline in HbA1c with empagliflozin 25 
      mg/linagliptin 5 mg, empagliflozin 10 mg/linagliptin 5 mg, empagliflozin 25 mg, 
      empagliflozin 10 mg, and linagliptin 5 mg were -1.08 (0.06)% (-11.8 [0.7] 
      mmol/mol), -1.24 (0.06)% (-13.6 [0.7] mmol/mol), -0.95 (0.06)% (-10.4 [0.7] 
      mmol/mol), -0.83 (0.06)% (-9.1 [0.7] mmol/mol), and -0.67 (0.06)% (-7.3 [0.7] 
      mmol/mol), respectively. Reductions in HbA1c were significantly greater for 
      empagliflozin 25 mg/linagliptin 5 mg compared with linagliptin 5 mg (P < 0.001) 
      but not compared with empagliflozin 25 mg and were significantly greater for 
      empagliflozin 10 mg/linagliptin 5 mg compared with the individual components (P < 
      0.001 for both). At week 24, 55.4%, 62.3%, 41.5%, 38.8%, and 32.3% of subjects 
      with baseline HbA1c >/=7% (>/=53 mmol/mol) reached HbA1c <7% with empagliflozin 25 
      mg/linagliptin 5 mg, empagliflozin 10 mg/linagliptin 5 mg, empagliflozin 25 mg, 
      empagliflozin 10 mg, and linagliptin 5 mg, respectively. Efficacy was maintained 
      at week 52. The proportion of subjects with adverse events (AEs) over 52 weeks 
      was similar across groups (68.9-81.5%), with no confirmed hypoglycemic AEs. 
      CONCLUSIONS: Reductions from baseline in HbA1c with empagliflozin/linagliptin 
      were significantly different versus linagliptin and empagliflozin 10 mg but not 
      versus empagliflozin 25 mg. Empagliflozin/linagliptin was well tolerated.
CI  - (c) 2015 by the American Diabetes Association. Readers may use this article as long 
      as the work is properly cited, the use is educational and not for profit, and the 
      work is not altered.
FAU - Lewin, Andrew
AU  - Lewin A
AD  - National Research Institute, Los Angeles, CA.
FAU - DeFronzo, Ralph A
AU  - DeFronzo RA
AD  - University of Texas Health Science Center, San Antonio, TX defronzo@uthscsa.edu.
FAU - Patel, Sanjay
AU  - Patel S
AD  - Boehringer Ingelheim Ltd., Bracknell, Berkshire, U.K.
FAU - Liu, Dacheng
AU  - Liu D
AD  - Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT.
FAU - Kaste, Renee
AU  - Kaste R
AD  - Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT.
FAU - Woerle, Hans J
AU  - Woerle HJ
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
FAU - Broedl, Uli C
AU  - Broedl UC
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT01422876
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150129
PL  - United States
TA  - Diabetes Care
JT  - Diabetes care
JID - 7805975
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Blood Glucose)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glucosides)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Purines)
RN  - 0 (Quinazolines)
RN  - 3X29ZEJ4R2 (Linagliptin)
RN  - HDC1R2M35U (empagliflozin)
SB  - IM
EIN - Diabetes Care. 2015 Jun;38(6):1173. PMID: 25998299
MH  - Benzhydryl Compounds/*administration & dosage
MH  - Blood Glucose/drug effects
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/*administration & dosage
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glucosides/*administration & dosage
MH  - Glycated Hemoglobin/drug effects
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage
MH  - Linagliptin
MH  - Male
MH  - Middle Aged
MH  - Purines/*administration & dosage
MH  - Quinazolines/*administration & dosage
MH  - Treatment Outcome
EDAT- 2015/01/31 06:00
MHDA- 2015/09/10 06:00
CRDT- 2015/01/31 06:00
PHST- 2015/01/31 06:00 [entrez]
PHST- 2015/01/31 06:00 [pubmed]
PHST- 2015/09/10 06:00 [medline]
AID - dc14-2365 [pii]
AID - 10.2337/dc14-2365 [doi]
PST - ppublish
SO  - Diabetes Care. 2015 Mar;38(3):394-402. doi: 10.2337/dc14-2365. Epub 2015 Jan 29.