ACARBOSE (Page 2 of 5)

Clinical Experience in Type 2 Diabetes Mellitus Patients on Monotherapy, or in Combination with Sulfonylureas, Metformin or Insulin

Acarbose Tablets were studied as monotherapy and as combination therapy to sulfonylurea, metformin, or insulin treatment. The treatment effects on HbA1c levels and one-hour postprandial glucose levels are summarized for four placebo-controlled, double-blind, randomized studies conducted in the United States in Tables 2 and 3, respectively. The placebo-subtracted treatment differences, which are summarized below, were statistically significant for both variables in all of these studies.

Study 1 (n=109) involved patients on background treatment with diet only. The mean effect of the addition of Acarbose Tablets to diet therapy was a change in HbA1c of -0.78%, and an improvement of one-hour postprandial glucose of -74.4 mg/dL.

In Study 2 (n=137), the mean effect of the addition of Acarbose Tablets to maximum sulfonylurea therapy was a change in HbA1c of -0.54%, and an improvement of one-hour postprandial glucose of -33.5 mg/dL.

In Study 3 (n=147), the mean effect of the addition of Acarbose Tablets to maximum metformin therapy was a change in HbA1c of -0.65%, and an improvement of one-hour postprandial glucose of -34.3 mg/dL.

Study 4 (n=145) demonstrated that Acarbose Tablets added to patients on background treatment with insulin resulted in a mean change in HbA1c of -0.69%, and an improvement of one-hour postprandial glucose of -36.0 mg/dL.

A one year study of Acarbose Tablets as monotherapy or in combination with sulfonylurea, metformin or insulin treatment was conducted in Canada in which 316 patients were included in the primary efficacy analysis (Figure 2). In the diet, sulfonylurea and metformin groups, the mean decrease in HbA1c produced by the addition of Acarbose Tablets was statistically significant at six months, and this effect was persistent at one year. In the Acarbose Tablets-treated patients on insulin, there was a statistically significant reduction in HbA1c at six months, and a trend for a reduction at one year.

Table 2: Effect of Acarbose Tablets on HbA1c
HbA1c(%) *
Study Treatment Mean Baseline Mean change from baseline Treatment Difference p-Value
*
HbA1c Normal Range: 4 to 6%
After four months treatment in Study 1, and six months in Studies 2, 3, and 4
SFU, sulfonylurea, maximum dose
§
Although studies utilized a maximum dose of up to 300 mg t.i.d., the maximum recommended dose for Patients ≤ 60 kg is 50 mg t.i.d.; the maximum recommended dose for patients > 60 kg is 100 mg t.i.d.
Metformin dosed at 2000 mg/day or 2500 mg/day
#
Results are adjusted to a common baseline of 8.33%
Þ
Mean dose of insulin 61 U/day

1

Placebo Plus Diet

8.67

+0.33

Acarbose Tablets 100 mg t.i.d. Plus Diet

8.69

-0.45

-0.78

0.0001

2

Placebo Plus SFU

9.56

+0.24

Acarbose Tablets 50 to 300§ mg t.i.d. Plus SFU

9.64

-0.30

-0.54

0.0096

3

Placebo Plus Metformin

8.17

+0.08#

Acarbose Tablets 50 to 100 mg t.i.d Plus Metformin

8.46

-0.57#

-0.65

0.0001

4

Placebo Plus Insulin Þ

8.69

+0.11

Acarbose Tablets 50 to 100 mg t.i.d. Plus Insulin Þ

8.77

-0.58

-0.69

0.0001

Table 3: Effect of Acarbose Tablets on Postprandial Glucose
*
After four months treatment in Study 1, and six months in Studies 2, 3, and 4
SFU, sulfonylurea, maximum dose
Although studies utilized a maximum dose of up to 300 mg t.i.d., the maximum recommended dose for patients ≤ 60 kg is 50 mg t.i.d.; the maximum recommended dose for patients > 60 kg is 100 mg t.i.d.
§
Metformin dosed at 2000 mg/day or 2500 mg/day
Results are adjusted to a common baseline of 273 mg/dL
#
Mean dose of insulin 61 U/day

One-Hour Postprandial Glucose (mg/dL)

Study

Treatment

Mean Baseline

Mean change from baseline *

Treatment Difference

p-Value

1

Placebo Plus Diet

297.1

+31.8

Acarbose Tablets 100 mg t.i.d. Plus Diet

299.1

-42.6

-74.4

0.0001

2

Placebo Plus SFU

308.6

+6.2

Acarbose Tablets 50 to 300 mg t.i.d. Plus SFU

311.1

-27.3

-33.5

0.0017

3

Placebo Plus Metformin §

263.9

+3.3

Acarbose Tablets 50 to 100 mg t.i.d Plus Metformin §

283.0

-31.0

-34.3

0.0001

4

Placebo Plus Insulin #

279.2

+8.0

Acarbose Tablets 50 to 100 mg t.i.d. Plus Insulin #

277.8

-28.0

-36.0

0.0178

Figure 2

Figure 2
(click image for full-size original)

Figure 2: Effects of Acarbose Tablets (▪) and Placebo (•) on mean change in HbA1c levels from baseline throughout a one-year study in patients with type 2 diabetes mellitus when used in combination with: (A) diet alone; (B) sulfonylurea; (C) metformin; or (D) insulin. Treatment differences at 6 and 12 months were tested:
* p < 0.01; # p = 0.077.

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