PMID- 29970184
OWN - NLM
STAT- MEDLINE
DCOM- 20190325
LR  - 20221207
IS  - 2050-6511 (Electronic)
IS  - 2050-6511 (Linking)
VI  - 19
IP  - 1
DP  - 2018 Jul 3
TI  - Effect of Linagliptin and Voglibose on metabolic profile in patients with Type 2 
      Diabetes: a randomized, double-blind, placebo-controlled trial.
PG  - 38
LID - 10.1186/s40360-018-0228-z [doi]
LID - 38
AB  - BACKGROUND: Dipeptidyl peptidase 4 (DPP4) inhibitors improve glycemic control by 
      promoting GLP1-mediated glucose-dependent insulin secretion and suppression of 
      glucagon. Sitagliptin and vildagliptin have been shown to improve insulin 
      sensitivity in patients with type 2 diabetes mellitus (T2DM). However, these 
      patients had uncontrolled blood glucose at inclusion; therefore, the improvement 
      in insulin sensitivity observed in these studies could be attributed to the drug 
      per se and/or reduction in glucotoxicity. This study examines the effect of 
      linagliptin on insulin sensitivity and beta-cell function in patients with 
      well-controlled T2DM. METHODS: Thirty patients with T2DM of duration </=5 years, 
      and having HbA1c < 7.5% were randomized to receive linagliptin, voglibose or 
      placebo (n = 10 each), and were followed up for 6 months. Insulin sensitivity was 
      assessed by hyperinsulinemic-euglycemic clamp, and insulin secretory response was 
      measured by basal (M(0)) and postprandial (M(1)) beta-cell function, and area under 
      curve (AUC) for C-peptide during mixed meal tolerance test. RESULTS: The median 
      HbA1c of the study subjects at inclusion was 6.9% and there was no significant 
      difference among the groups in terms of age, duration of diabetes, body mass 
      index (BMI), HbA1c, insulin sensitivity, AUC of C-peptide and M(0) and M(1) at 
      baseline. At the end of the study, there was a modest reduction in HbA1c (- 0.2%) 
      in the linagliptin group, and a significant decrease (- 0.8%) in the voglibose 
      group, as compared to placebo (p = 0.038). However, there were no significant 
      differences in insulin sensitivity, M(0) and M(1) and AUC of C-peptide, within, 
      or among the groups. CONCLUSION: Linagliptin modestly improves glycemic profile 
      in patients with well controlled T2DM; however, it may not have an effect on 
      insulin sensitivity in these patients. TRIAL REGISTRATION: Retrospectively 
      Registered in Clinicaltrials.gov (ID number, NCT02097342 ). Registered: March 27, 
      2014.
FAU - Parthan, Girish
AU  - Parthan G
AD  - Department of Endocrinology, Post Graduate Institute of Medical Education and 
      Research, Sector- 12, Chandigarh, PIN Code-160012, India.
FAU - Bhansali, Shobhit
AU  - Bhansali S
AD  - Department of Endocrinology, Post Graduate Institute of Medical Education and 
      Research, Sector- 12, Chandigarh, PIN Code-160012, India.
FAU - Kurpad, Anura V
AU  - Kurpad AV
AD  - Department of Physiology, St. John's Medical College, Bangalore, India.
FAU - Walia, Rama
AU  - Walia R
AD  - Department of Endocrinology, Post Graduate Institute of Medical Education and 
      Research, Sector- 12, Chandigarh, PIN Code-160012, India.
FAU - Bhat, Kishor
AU  - Bhat K
AD  - Department of Physiology, St. John's Medical College, Bangalore, India.
FAU - Bhansali, Anil
AU  - Bhansali A
AD  - Department of Endocrinology, Post Graduate Institute of Medical Education and 
      Research, Sector- 12, Chandigarh, PIN Code-160012, India. 
      anilbhansaliendocrine@gmail.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT02097342
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20180703
PL  - England
TA  - BMC Pharmacol Toxicol
JT  - BMC pharmacology & toxicology
JID - 101590449
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 3X29ZEJ4R2 (Linagliptin)
RN  - 4L6452S749 (Inositol)
RN  - S77P977AG8 (voglibose)
SB  - IM
MH  - Adult
MH  - Blood Glucose/drug effects
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Inositol/analogs & derivatives/therapeutic use
MH  - Insulin Resistance
MH  - Insulin-Secreting Cells/drug effects
MH  - Linagliptin/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Postprandial Period
PMC - PMC6030784
OTO - NOTNLM
OT  - T2DM, beta-cell function, insulin sensitivity, linagliptin, voglibose
COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: The study was performed according to 
      the declaration of Helsinki and was approved by the Institutional Ethics 
      Committee of Postgraduate Institute of Medical Education and Research, 
      Chandigarh, India. Written informed consent was obtained from all the patients to 
      participate in the study. CONSENT FOR PUBLICATION: The authors confirm that they 
      have obtained consent from the participants to publish the trial data. COMPETING 
      INTERESTS: The authors declare that they have no competing interests. PUBLISHER'S 
      NOTE: Springer Nature remains neutral with regard to jurisdictional claims in 
      published maps and institutional affiliations.
EDAT- 2018/07/05 06:00
MHDA- 2019/03/26 06:00
PMCR- 2018/07/03
CRDT- 2018/07/05 06:00
PHST- 2018/04/08 00:00 [received]
PHST- 2018/06/20 00:00 [accepted]
PHST- 2018/07/05 06:00 [entrez]
PHST- 2018/07/05 06:00 [pubmed]
PHST- 2019/03/26 06:00 [medline]
PHST- 2018/07/03 00:00 [pmc-release]
AID - 10.1186/s40360-018-0228-z [pii]
AID - 228 [pii]
AID - 10.1186/s40360-018-0228-z [doi]
PST - epublish
SO  - BMC Pharmacol Toxicol. 2018 Jul 3;19(1):38. doi: 10.1186/s40360-018-0228-z.