PMID- 23909985
OWN - NLM
STAT- MEDLINE
DCOM- 20141117
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 16
IP  - 3
DP  - 2014 Mar
TI  - Efficacy and safety of initial combination treatment with sitagliptin and 
      pioglitazone--a factorial study.
PG  - 223-30
LID - 10.1111/dom.12194 [doi]
AB  - AIM: To evaluate the efficacy and safety of initial combination therapy of 
      sitagliptin 100 mg/day coadministered with all marketed doses of pioglitazone in 
      patients with type 2 diabetes. METHODS: Patients with A1c >/=7.5 and </=11.0% were 
      randomized among seven arms that received, once daily, 100 mg sitagliptin alone; 
      15, 30 or 45 mg pioglitazone alone, or 100 mg sitagliptin plus 15, 30 or 45 mg 
      pioglitazone for 54 weeks. The primary endpoint was change from baseline in A1c 
      at week 24. Protocol-specified analyses compared combination therapies with 
      monotherapies at respective dose-strengths and combination of sitagliptin plus 
      pioglitazone 30 mg with pioglitazone 45 mg monotherapy. Post-hoc analyses 
      compared sitagliptin plus pioglitazone 15 mg with pioglitazone monotherapy at the 
      two higher doses. RESULTS: Initial combination therapy with sitagliptin and 
      pioglitazone provided significantly greater reductions in A1c (0.4-0.7% 
      differences) and other glycaemic endpoints than either monotherapy at the same 
      doses. Combining sitagliptin with low-dose pioglitazone generally produced 
      greater glycaemic improvements than higher doses of pioglitazone monotherapy 
      (0.3-0.4% differences in A1c). Combination therapy was generally well tolerated; 
      adverse events (AEs) of hypoglycaemia were reported with similar incidence 
      (7.8-11.1%) in all treatment groups over the 54 weeks of study; oedema was 
      reported in 0.5% of patients in the sitagliptin monotherapy group and 2.7-5.3% 
      among pioglitazone-treated groups. Significant weight gain was observed in all 
      combination-treated groups compared with the sitagliptin monotherapy group. 
      CONCLUSIONS: Initial combination therapy with sitagliptin and pioglitazone 
      provided better glycaemic control than either monotherapy and was generally well 
      tolerated.
CI  - (c) 2013 John Wiley & Sons Ltd.
FAU - Henry, R R
AU  - Henry RR
AD  - Center for Metabolic Research, VA San Diego Healthcare System, San Diego, CA, 
      USA; University of California San Diego, San Diego, CA, USA.
FAU - Staels, B
AU  - Staels B
FAU - Fonseca, V A
AU  - Fonseca VA
FAU - Chou, M Z
AU  - Chou MZ
FAU - Teng, R
AU  - Teng R
FAU - Golm, G T
AU  - Golm GT
FAU - Langdon, R B
AU  - Langdon RB
FAU - Kaufman, K D
AU  - Kaufman KD
FAU - Steinberg, H
AU  - Steinberg H
FAU - Goldstein, B J
AU  - Goldstein BJ
LA  - eng
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 (Blood Glucose)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Pyrazines)
RN  - 0 (Thiazolidinediones)
RN  - 0 (Triazoles)
RN  - 0 (hemoglobin A1c protein, human)
RN  - TS63EW8X6F (Sitagliptin Phosphate)
RN  - X4OV71U42S (Pioglitazone)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Blood Glucose/*drug effects/metabolism
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/*administration & dosage
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/*drug effects/metabolism
MH  - Humans
MH  - Hypoglycemia/drug therapy
MH  - Hypoglycemic Agents/*administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Pioglitazone
MH  - Pyrazines/*administration & dosage
MH  - Sitagliptin Phosphate
MH  - Thiazolidinediones/*administration & dosage
MH  - Treatment Outcome
MH  - Triazoles/*administration & dosage
OTO - NOTNLM
OT  - DPP-4 inhibitor
OT  - glycaemic control
OT  - incretins
OT  - sitagliptin
EDAT- 2013/08/06 06:00
MHDA- 2014/11/18 06:00
CRDT- 2013/08/06 06:00
PHST- 2013/02/26 00:00 [received]
PHST- 2013/04/08 00:00 [revised]
PHST- 2013/07/29 00:00 [accepted]
PHST- 2013/08/06 06:00 [entrez]
PHST- 2013/08/06 06:00 [pubmed]
PHST- 2014/11/18 06:00 [medline]
AID - 10.1111/dom.12194 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2014 Mar;16(3):223-30. doi: 10.1111/dom.12194. Epub 2013 Aug 
      29.