Efficacy and safety of coadministration of sitagliptin with insulin glargine in type 2 diabetes.

Abstract

BACKGROUND:

The aim of the randomized present study was to compare the therapeutic efficacy and safety of a combination of sitagliptin, a dipeptidyl peptidase (DPP)-4 inhibitor, plus insulin glargine (GL + sita) with that of premixed insulin aspart 30 (NOV) for type 2 diabetes (T2D) patients controlled with oral hypoglycemic drugs (HbA1c 7 %-9 %).

METHODS:

Sixty-five patients were randomized (1:  1) to the GL + sita (n = 33) and NOV (n = 32) groups and were treated with the combination regimen or premixed insulin twice a day for 16 weeks. The primary endpoint was mean change in HbA1c. Secondary endpoints included fasting blood glucose, blood glucose profiles (seven time points), rate of achieving target HbA1c (<7 % or ≤6.5 %), insulin dose, incidence of hypoglycemia, and body weight.

RESULTS:

After 16 weeks, there was no significant difference in HbA1c between the two groups, although more patients achieved HbA1c <7.0 % in the GL + sita group. There was a significant difference in body weight changes between the GL + sita and NOV groups (-0.45 vs 1.52 kg, respectively; P < 0.001). Mean plasma glucose and the mean amplitude of glycemic excursion were significantly lower in the GL + sita than NOV group (P < 0.005), as was the incidence of symptomatic hypoglycemia (2.85 % vs. 13.3 %, respectively; P < 0.001).

CONCLUSION:

The combination of GL + sita greatly improved HbA1c in T2D patients (HbA1c 7 %-9 %) with an efficacy that was equal to that of premixed insulin. Thus, GL + sita treatment is a viable option for patients who fail to achieve glycemic control using oral hypoglycemic drugs.

• Authors: Ying Cao, Fang Gao, Qian Zhang, Lingling Xu, Qian Wan, Wenqi Li, Jimin Li, Ling Wang, Yaoming Xue
• Journal: Journal of diabetes (J Diabetes) Vol. 9 Issue 5 Pg. 502-509 (May 2017) ISSN: 1753-0407 [Electronic] Australia
• PMID: 27255431 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: © 2016 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

Chemical References

• Blood Glucose
• C-Peptide
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Insulin Glargine
• Sitagliptin Phosphate

Topics

• Adult
• Blood Glucose (analysis)
• Blood Glucose Self-Monitoring (methods)
• C-Peptide (blood)
• Diabetes Mellitus, Type 2 (blood, drug therapy)
• Drug Administration Schedule
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• Glycated Hemoglobin (analysis)
• Humans
• Hypoglycemic Agents (administration & dosage, adverse effects, therapeutic use)
• Insulin Glargine (administration & dosage, adverse effects, therapeutic use)
• Male
• Middle Aged
• Sitagliptin Phosphate (administration & dosage, adverse effects, therapeutic use)
• Treatment Outcome