Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access
Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc
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Original Article

Volume 7, Number 8, August 2015, pages 607-612

Factors Predicting Therapeutic Efficacy of Combination Treatment With Sitagliptin and Insulin in Type 2 Diabetic Patients: The ASSIST-K Study


Figure 1.
Figure 1. Changes in hemoglobin A1c, body weight, and insulin dose (n = 1,004). Data are the mean ± standard deviation. Analysis of variance vs. baseline. *P < 0.05. M: months.


Table 1. Characteristics of the Subjects
Data are mean ± standard deviation unless otherwise indicated.
Age, years63.9 ± 12.1
Sex, male/female521/483
Body mass index25.5 ± 4.6
Hemoglobin A1c, % (mmol/mol)8.69 ± 1.31 (72 ± 12)
Fasting blood glucose, mg/dL (mmol/L)184.3 ± 70.5 (10.23 ± 3.91)
Serum C-peptide, ng/mL (nmol/L)1.47 ± 1.03 (0.49 ± 0.34)
Duration of diabetes, years17.1 ± 9.0
Duration of insulin treatment, years6.3 ± 5.6
Smoking, %23.1
Alcohol consumption, %22.7
Complications, %
  Diabetic neuropathy33.6
  Diabetic retinopathy33.4
  Diabetic nephropathy38.5
  Cerebrovascular disease7.6
  Myocardial infarction/angina pectoris17.3
  Arteriosclerosis obliterans8.8
  Hepatic steatosis30.0
Insulin regimen, n
  Long-acting insulin, once daily215
  Mixed insulin, twice daily162
  Three times daily, no long-acting insulin209
  Basal-bolus insulin334
Concomitant oral medications, n
  Alpha-glucosidase inhibitors184
Dose of sitagliptin, n
  25 mg throughout65
  Up-titration from 25 mg to 50 mg83
  50 mg throughout809
  Up-titration from 50 mg to 100 mg47


Table 2. Changes in Laboratory Values
Clinical parameternBaseline1 month3 months6 monthsDifference between baseline and 6 months
aP < 0.05 (analysis of variance vs. baseline). BP: blood pressure; HDL: high-density lipoprotein; LDL: low-density lipoprotein.
Systolic BP, mm Hg923130.82130.85130.38130.28
Diastolic BP, mm Hg92374.9774.66a74.03a74.22a-0.75
Fasting blood glucose, mg/dL (mmol/L)199181.35 (10.06)160.62 (8.91)a164.81 (9.15)a160.9 (8.93)a-20.45 (-1.13)
Serum C-peptide, ng/dL (nmol/L)530.91 (0.30)0.98 (0.32)1 (0.33)0.96 (0.32)
Glycated albumin, %5323.221.61a21.05a21.03a-2.17
Aspartate aminotransferase, IU/L (µkat/L)77327.62 (0.46)26.41 (0.44)27.02 (0.45)27.56 (0.46)
Alanine aminotransferase, IU/L (µkat/L)77024.66 (0.41)24.11 (0.40)24.79 (0.41)24.22 (0.40)
Gamma-glutamyl transpeptidase, IU/L70344.1242.2242.1243.47
Alkaline phosphatase, mg/dL175260.05254.16a241.82a241.83a-18.22
Total cholesterol, mg/dL (mmol/L)453194.72 (5.04)191.56 (4.96)a190.26 (4.93)a191.39 (4.96)a-3.33 (-0.08)
LDL cholesterol, mg/dL (mmol/L)733109.66 (2.84)109.02 (2.82)108.67 (2.81)109.08 (2.83)
HDL cholesterol, mg/dL (mmol/L)79455.62 (1.44)55.05 (1.43)a54.8 (1.42)a54.72 (1.42)a-0.90 (-0.02)
Triglycerides, mg/dL (mmol/L)805164.12 (1.85)153.61 (1.74)a153.3 (1.73)a155.33 (1.76)a-8.79 (-0.09)
Uric acid, mg/dL (µmol/L)3315.05 (300.40)5.18 (308.13)a5.32 (316.46)a5.27 (313.49)a+0.25 (+13.09)
Creatinine, mg/dL (µmol/L)6740.76 (67.18)0.77 (68.07)a0.78 (68.95)a0.79 (69.84)a+0.03 (+2.66)


Table 3. Multiple Regression Analysis of Delta Hemoglobin A1c After 6 Months of Insulin-Sitagliptin Combination Therapy in 495 Patients With Complete Data
FactorBeta valueP valueStandardized beta value
Female sex0.1640.08020.080
Baseline body mass index0.0300.00480.136
Duration of insulin treatment, years0.0130.13830.065
Baseline hemoglobin A1c-0.400< 0.0001-0.502
Baseline daily insulin dose0.0020.24010.057
Presence of diabetic neuropathy0.0510.55120.025
Smoking, yes0.0040.96940.002
Alcohol consumption, yes-0.0040.9683-0.002
Alpha-glucosidase inhibitors-0.0960.3606-0.037