PMID- 25850968
OWN - NLM
STAT- MEDLINE
DCOM- 20151201
LR  - 20181202
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 31
IP  - 6
DP  - 2015 Jun
TI  - Long-term efficacy of sitagliptin as either monotherapy or add-on therapy to 
      metformin: improvement in glycemic control over 2 years in patients with type 2 
      diabetes.
PG  - 1071-7
LID - 10.1185/03007995.2015.1037259 [doi]
AB  - OBJECTIVE: To evaluate the efficacy of once daily sitagliptin 100 mg as 
      monotherapy or as add-on to metformin in patients with type 2 diabetes mellitus 
      (T2DM) over 2 years of treatment. RESEARCH DESIGN AND METHODS: The monotherapy 
      analysis used pooled 104 week data from 64 patients in two randomized, 
      double-blind trials evaluating the safety and efficacy of sitagliptin 
      monotherapy. Data used were from patients who were randomized to sitagliptin 
      100 mg/day, were not on an antihyperglycemic agent at the screening visit, had 
      baseline A1C of 7.0%-10.0%, and had Week 104 A1C measurements. The add-on to 
      metformin analysis used pooled data from 347 patients in two randomized 
      double-blind trials evaluating the safety and efficacy of sitagliptin + metformin 
      combination therapy. Data used were from patients who were randomized to 
      sitagliptin 100 mg/day + metformin >/=1500 mg/day, had baseline A1C of 7%-10%, and 
      had Week 104 A1C measurements. Excluded from either analysis were patients who 
      discontinued prior to 2 years (e.g., due to lack of efficacy, a need for rescue 
      medications, or adverse experiences). Analysis endpoints were A1C, fasting plasma 
      glucose (FPG), HOMA-beta, proinsulin/insulin (P/I) ratio, and for monotherapy, 2 
      hour post-meal plasma glucose (PMG). RESULTS: For the pooled monotherapy cohort, 
      after 2 years of treatment, mean A1C, FPG, and 2 hour PMG decreased from baseline 
      values of 7.9%, 156 mg/dL, and 223 mg/dL to 6.9%, 143 mg/dL, and 191 mg/dL, 
      respectively, while HOMA-beta increased from 67% to 85% and P/I ratio improved from 
      0.57 to 0.28. For the pooled add-on to metformin cohort, after 2 years of 
      treatment, mean A1C and FPG decreased from baseline values of 7.7% and 160 mg/dL 
      to 6.9% and 140 mg/dL, respectively, while HOMA-beta increased from 50% to 62% and 
      P/I ratio improved from 0.33 to 0.28. These analyses are limited in that only 
      patients who were able to complete 104 weeks of study were included. CONCLUSION: 
      In the subset of patients with T2DM who maintained and completed treatment for 2 
      years with sitagliptin as monotherapy or as add-on to metformin, improvements in 
      glycemic control and measures of beta-cell function were observed over the course of 
      treatment.
FAU - Katzeff, H L
AU  - Katzeff HL
AD  - Merck & Co. Inc., Kenilworth , NJ , USA.
FAU - Williams-Herman, D
AU  - Williams-Herman D
FAU - Xu, L
AU  - Xu L
FAU - Golm, G T
AU  - Golm GT
FAU - Wang, H
AU  - Wang H
FAU - Dong, Q
AU  - Dong Q
FAU - Johnson, J R
AU  - Johnson JR
FAU - O'Neill, E A
AU  - O'Neill EA
FAU - Kaufman, K D
AU  - Kaufman KD
FAU - Engel, S S
AU  - Engel SS
FAU - Goldstein, B J
AU  - Goldstein BJ
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 9100L32L2N (Metformin)
RN  - TS63EW8X6F (Sitagliptin Phosphate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Blood Glucose/drug effects
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage/therapeutic use
MH  - Insulin-Secreting Cells/metabolism
MH  - Male
MH  - Metformin/*administration & dosage
MH  - Middle Aged
MH  - Postprandial Period
MH  - Sitagliptin Phosphate/*administration & dosage/therapeutic use
OTO - NOTNLM
OT  - Beta-cell function
OT  - DPP-4
OT  - HOMA-beta
OT  - Incretins
OT  - P/I ratio
OT  - Type 2 diabetes disease progression
EDAT- 2015/04/09 06:00
MHDA- 2015/12/15 06:00
CRDT- 2015/04/09 06:00
PHST- 2015/04/09 06:00 [entrez]
PHST- 2015/04/09 06:00 [pubmed]
PHST- 2015/12/15 06:00 [medline]
AID - 10.1185/03007995.2015.1037259 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2015 Jun;31(6):1071-7. doi: 10.1185/03007995.2015.1037259.