PMID- 21205123
OWN - NLM
STAT- MEDLINE
DCOM- 20110603
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 13
IP  - 3
DP  - 2011 Mar
TI  - Efficacy and safety of insulin detemir once daily in combination with sitagliptin 
      and metformin: the TRANSITION randomized controlled trial.
PG  - 268-75
LID - 10.1111/j.1463-1326.2010.01351.x [doi]
AB  - AIM: The aim of this trial was to evaluate the efficacy and safety of the 
      combination of once-daily insulin detemir (IDet) and sitagliptin (SITA) versus 
      SITA +/- sulphonylurea (SU), both in combination with metformin (MET) in 
      insulin-naive subjects. METHODS: In a 26-week, open-label, randomized, 
      parallel-group study in type 2 diabetes, insulin-naive subjects concomitantly 
      treated with MET +/- second oral antidiabetic drug (OAD) were randomized 1 : 1 to 
      IDet + SITA + MET or SITA + MET +/- SU. All continued with MET treatment, and those 
      treated with SU continued if randomized to SITA + MET +/- SU. Efficacy endpoints 
      included glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG), 9-point 
      self-measured plasma glucose (SMPG), weight, body mass index (BMI). Safety 
      endpoints included adverse events (AEs) and hypoglycaemia. RESULTS: Significantly 
      higher reductions in HbA1c, FPG and SMPG were achieved with IDet + SITA + MET 
      compared with SITA + MET +/- SU. Estimated HbA1c decreased by 1.44% in the IDet + 
      SITA + MET group versus 0.89% in SITA + MET +/- SU, p < 0.001. FPG decreased by 3.7 
      mmol/l (66.3 mg/dl) versus 1.2 mmol/l (22.2 mg/dl), p < 0.001, respectively. 
      Small decreases in weight and BMI were observed in both arms, with no significant 
      differences. AEs were mild or moderate and were more common in the SITA + MET +/- 
      SU arm than in the IDet + SITA + MET arm. There was no major hypoglycaemia. 
      Observed rates of hypoglycaemia were very low (1.3/1.7 episodes/patient year) in 
      both arms. The subgroup treated with MET and SUs prior to the trial achieved 
      similar results. CONCLUSIONS: The combination of once-daily IDet with SITA showed 
      a clinically and significantly better improvement in glycaemic control than SITA 
      in combination with or without SUs. Both regimens were associated with a low rate 
      of hypoglycaemia and slight weight reduction.
CI  - (c) 2011 Blackwell Publishing Ltd.
FAU - Hollander, P
AU  - Hollander P
AD  - Baylor Endocrine Center, Baylor University Medical Center, Dallas, TX, USA. 
      priscilh@BaylorHealth.edu
FAU - Raslova, K
AU  - Raslova K
FAU - Skjoth, T V
AU  - Skjoth TV
FAU - Rastam, J
AU  - Rastam J
FAU - Liutkus, J F
AU  - Liutkus JF
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Insulin, Long-Acting)
RN  - 0 (Pyrazines)
RN  - 0 (Triazoles)
RN  - 4FT78T86XV (Insulin Detemir)
RN  - 9100L32L2N (Metformin)
RN  - TS63EW8X6F (Sitagliptin Phosphate)
SB  - IM
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/drug effects
MH  - Humans
MH  - Hypoglycemia/*drug therapy/prevention & control
MH  - Hypoglycemic Agents/*administration & dosage/pharmacology
MH  - Insulin/administration & dosage/*analogs & derivatives/pharmacology
MH  - Insulin Detemir
MH  - Insulin, Long-Acting
MH  - Male
MH  - Metformin/*administration & dosage/pharmacology
MH  - Middle Aged
MH  - Pyrazines/*administration & dosage/pharmacology
MH  - Sitagliptin Phosphate
MH  - Treatment Outcome
MH  - Triazoles/*administration & dosage/pharmacology
MH  - Weight Loss/drug effects
EDAT- 2011/01/06 06:00
MHDA- 2011/06/04 06:00
CRDT- 2011/01/06 06:00
PHST- 2011/01/06 06:00 [entrez]
PHST- 2011/01/06 06:00 [pubmed]
PHST- 2011/06/04 06:00 [medline]
AID - 10.1111/j.1463-1326.2010.01351.x [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2011 Mar;13(3):268-75. doi: 
      10.1111/j.1463-1326.2010.01351.x.