PMID- 23757615
OWN - NLM
STAT- MEDLINE
DCOM- 20140612
LR  - 20221207
IS  - 1934-2403 (Electronic)
IS  - 1530-891X (Linking)
VI  - 19
IP  - 5
DP  - 2013 Sep-Oct
TI  - Assessment of AACE/ACE recommendations for initial dual antihyperglycemic therapy 
      using the fixed-dose combination of sitagliptin and metformin versus metformin.
PG  - 751-7
LID - 10.4158/EP12436.OR [doi]
AB  - OBJECTIVE: The American Association of Clinical Endocrinologists and American 
      College of Endocrinology (AACE/ACE) diabetes algorithm recommends a stratified 
      approach to initial therapy to achieve a glycated hemoglobin (HbA1c) goal of 
      </=6.5% in patients with type 2 diabetes mellitus (T2DM) who have inadequate 
      glycemic control. Data from a double-blind study in drug-naive T2DM patients 
      comparing initial monotherapy with metformin (MET) with initial dual therapy with 
      a fixed-dose combination of sitagliptin and MET (SITA/MET FDC) was used to 
      determine AACE/ACE HbA1c goal attainment in these treatment groups. METHODS: A 
      total of 1,250 patients (mean baseline HbA1c = 9.9%) were randomized 1:1 to 
      SITA/MET FDC 50/500 mg twice daily (b.i.d.) or MET 500 mg b.i.d. for 18 weeks. 
      SITA/MET FDC and MET were uptitrated over 4 weeks to 50/1,000 mg b.i.d. and 1,000 
      mg b.i.d., respectively. RESULTS: At week 18, a higher percentage of patients 
      receiving SITA/MET FDC had HbA1c levels </=6.5% and <7% than those receiving MET 
      alone within each of the 3 AACE/ACE HbA1c categories (6.5-7.5%, >7.5-9.0%, and 
      >9.0%). Of patients with a baseline HbA1c >7.5-9.0% who initiated SITA/MET FDC, 
      48.6% achieved an HbA1c </=6.5% at week 18 compared with 23.1% of patients who 
      initiated MET monotherapy (P<.001). In patients with a baseline HbA1c >9.0%, 
      24.0% on SITA/MET FDC achieved an HbA1c </=6.5% compared with 12.8% on MET alone 
      (P<.001). CONCLUSION: In T2DM patients with a baseline HbA1c >7.5-9.0%, 
      substantially more achieved the HbA1c goal of </=6.5% with initial dual therapy 
      (SITA/MET FDC) than with initial monotherapy (MET), which is in agreement with 
      the AACE/ACE diabetes algorithm.
FAU - Engel, Samuel S
AU  - Engel SS
AD  - Clinical Research, Diabetes and Endocrine, Merck Sharp & Dohme Corp, Rahway, New 
      Jersey.
FAU - Seck, Thomas L
AU  - Seck TL
FAU - Golm, Gregory T
AU  - Golm GT
FAU - Meehan, Alan G
AU  - Meehan AG
FAU - Kaufman, Keith D
AU  - Kaufman KD
FAU - Goldstein, Barry J
AU  - Goldstein BJ
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Endocr Pract
JT  - Endocrine practice : official journal of the American College of Endocrinology 
      and the American Association of Clinical Endocrinologists
JID - 9607439
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Pyrazines)
RN  - 0 (Triazoles)
RN  - 9100L32L2N (Metformin)
RN  - TS63EW8X6F (Sitagliptin Phosphate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/*therapeutic use
MH  - Male
MH  - Metformin/administration & dosage/*therapeutic use
MH  - Middle Aged
MH  - Pyrazines/administration & dosage/*therapeutic use
MH  - Sitagliptin Phosphate
MH  - Triazoles/administration & dosage/*therapeutic use
MH  - Young Adult
EDAT- 2013/06/13 06:00
MHDA- 2014/06/13 06:00
CRDT- 2013/06/13 06:00
PHST- 2013/06/13 06:00 [entrez]
PHST- 2013/06/13 06:00 [pubmed]
PHST- 2014/06/13 06:00 [medline]
AID - S1530-891X(20)44645-2 [pii]
AID - 10.4158/EP12436.OR [doi]
PST - ppublish
SO  - Endocr Pract. 2013 Sep-Oct;19(5):751-7. doi: 10.4158/EP12436.OR.