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Table 2 Results

From: Patients with Type 2 Diabetes Mellitus failing on oral agents and starting once daily insulin regimen; a small randomized study investigating effects of adding vildagliptin

 

Placebo

Vildagliptin

Primary endpoint

  

Units insulin

47 (16 – 62)

34 (12 – 62)

Secondary endpoints

  

Glycemic variability end of study (SD)

2.1 (1.1 – 2.8)

1.5 (1.0 – 3.6)

Change in weight (kg)

3 (−2.5 – 5.5)

0.5 (−2.6 – 4)

Hypoglycemia during the study (nr per pat)

1.5 (0 – 5)

1.0 (0 – 8)

Change in blood-pressure (mmHg)

  

Systolic

−3 (−12 – 6)

2.5 (−14 – 10)

Diastolic

−1.5 (−9 – 3)

−0.5 (−6 – 11)

Change in LDL (mmol/L)

0 (−1 – 0.6)

−0.3 (−1.4 – 0)

Change in SAF (skin AGEs) (AU)

0.1 (−0.4 – 0.8)

0.15 (−0.4 – 0.6)

Safety

  

Patients with one or more hypoglycemia (%)

67%

78%

Patients with severe hypoglycemia (%)

0%

0%

Patients with one or more AE (%)

100%

44%

Patients with one or more SAE (%)

0%

0%

Other

  

Delta HbA1c (mmol/mol)

−6.5 (−18 - 7)

−6 (−25 - 4)

(%)

−0.6 (−1.6 – 0.6)

−0.5 (−2.3 - 0.3)

Compliance (% of tablets taken)

96%

98%

  1. All values are in median (range) or percentages.
  2. Compliance:% of tablets taken during the whole study period.
  3. Delta HbA1c: HbA1c end-begin, −6 means a decrease of 6 points in HbA1c during the study, a number without – means an increase.
  4. Because of the small sample size no p-values are shown.
  5. Abbreviations; LDL = low-density lipoprotein, SAF = skin autofluorescence, AGEs = advanced glycation end products, AU = arbitrary units, AE = adverse event, SAE = serious adverse event, HbA1c = glycated hemoglobin.