PMID- 31571445
OWN - NLM
STAT- MEDLINE
DCOM- 20191008
LR  - 20220410
IS  - 0004-5772 (Print)
IS  - 0004-5772 (Linking)
VI  - 67
IP  - 10
DP  - 2019 Oct
TI  - A ProspectIve, OpeN-Label, Randomized Study Comparing EffIcacy and Safety of 
      Teneligliptin VErsus Sitagliptin in Indian Patients with Inadequately Controlled 
      Type 2 Diabetes Mellitus: INSITES Study.
PG  - 14-19
AB  - BACKGROUND: Teneligliptin is widely prescribed dipeptidyl peptidase-4 inhibitor 
      (DPP-4i) in India because of its economical pricing. However, there is no 
      headto-head trial comparing teneligliptin with any other DPP-4i in Indian 
      setting. We evaluated the efficacy and safety of teneligliptin versus sitagliptin 
      as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes 
      mellitus (T2DM). METHODS: This prospective, open-label, randomized, 
      active-controlled study enrolled 76 patients (1:1) at 2 centres. Patients 
      received teneligliptin 20 mg or sitagliptin 100 mg orally once daily for 12 weeks 
      as add-on to ongoing metformin or sulfonylurea therapy. Primary endpoint was mean 
      change in glycosylated hemoglobin (HbA1c) from baseline at week 12. RESULTS: Both 
      arms were comparable (p>0.05) at baseline in terms of age, gender, metformin 
      daily dose, sulfonylurea use, HbA1c, fasting and postprandial blood glucose (FBG 
      and PPBG). At the end of 12 weeks, statistically significant reductions were 
      observed in both teneligliptin and sitagliptin arms in HbA1c (-1.19 +/- 1.16% 
      p<0.0001 and -0.92 +/- 0.95%, p<0.0001), in FBG (-28.3 +/- 63.0 mg/dL, p= 0.01 and 
      -22.9 +/- 47.4 mg/dL, p=0.006) and PPBG (-41.3 +/- 85.4 mg/dL, p=0.006 and -54.7 +/- 
      85.6 mg/dL, p=0.0005). The reductions in all glycemic parameters were similar 
      between the arms. Both gliptins were well-tolerated with no difference in the 
      number of adverse events. There was no change in QT/QTc intervals or other ECG 
      parameters at week 12 in both arms. In post-hoc comparison, percentage of 
      patients achieving target HbA1c <7% (as per American Diabetes Association 
      guidelines) at week 12 favored teneligliptin arm over sitagliptin arm (33.3% vs. 
      19.4% patients). CONCLUSION: Teneligliptin provided similar glycemic control as 
      compared to sitagliptin and reduced HbA1c, FBG and PPBG values significantly 
      within 12 weeks of treatment. Both gliptins were found to be safe and 
      well-tolerated in Indian patients with T2DM.
CI  - (c) Journal of the Association of Physicians of India 2011.
FAU - Mohan, V
AU  - Mohan V
AD  - Madras Diabetes Research Foundation and Dr. Mohan's Diabetes Specialties Centre, 
      Chennai, Tamil Nadu , Corresponding Author.
FAU - Ramu, M
AU  - Ramu M
AD  - Madras Diabetes Research Foundation, Chennai, Tamil Nadu.
FAU - Poongothai, S
AU  - Poongothai S
AD  - Madras Diabetes Research Foundation, Chennai, Tamil Nadu.
FAU - Kasthuri, S
AU  - Kasthuri S
AD  - Madras Diabetes Research Foundation, Chennai, Tamil Nadu.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - India
TA  - J Assoc Physicians India
JT  - The Journal of the Association of Physicians of India
JID - 7505585
RN  - 0 
      (3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Pyrazoles)
RN  - 0 (Thiazolidines)
RN  - TS63EW8X6F (Sitagliptin Phosphate)
SB  - IM
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - India
MH  - Prospective Studies
MH  - Pyrazoles/*therapeutic use
MH  - Sitagliptin Phosphate/*therapeutic use
MH  - Thiazolidines/*therapeutic use
EDAT- 2019/10/02 06:00
MHDA- 2019/10/09 06:00
CRDT- 2019/10/02 06:00
PHST- 2019/10/02 06:00 [entrez]
PHST- 2019/10/02 06:00 [pubmed]
PHST- 2019/10/09 06:00 [medline]
PST - ppublish
SO  - J Assoc Physicians India. 2019 Oct;67(10):14-19.