Table 13Characteristics of sitagliptin add-on therapy placebo-controlled trials in adults with type 2 diabetes

Author, year
Country
Quality
Sample size (N)
Follow-up (weeks)
Age (years) (SD)a
% Femalea
% Whitea
% Hispanica
Baseline
HbA1c (%) (SD)a
Weight (kg)a
Intervention
Dosages
Charbonnel, 200647
Multinational
Fair
701
24
54.4–54.7 (9.7–10.4)
40.5–44.2
63.1–67.1
11.8–15.5
8.0a
171.5
Sitagliptin 100 mg or Placebo
Added-on to metformin ≥ 1500 mg/day
Rosenstock, 200648
Multinational
Fair
353
24
55.6–56.9 (10.4–11.1)
42.1–46.9
72.5–72.6
12.0–12.4
8.0–8.1 (0.8)b
165.6–168.3 (39.5–39.9)
Sitagliptin 100 mg or Placebo
Added-on to Pioglitazone 30–45 mg/day
Hermansen, 200749
Denmark, USA
Fair
441
24
55.6–56.5 (9.6)
46.6–47.3
61.3–63.9
14.6–17.6
8.34c
181.2
Sitagliptin 100 mg or Placebo
Added on to glimepiride 4–8 mg/day or glimepiride+ metformin >1500 mg/day
Scott, 200836
Multinational
Fair
273
18
54.8–55.3 (9.3–10.5)
39–41
NR
4.6–5.4 (3.5–4.0)
7.7–7.8 (0.8–1.0)
157–160 (31.4–37.4)
Sitagliptin 100 mg or Rosiglitazone 8 mg or Placebo
Added to metformin monotherapy ≥ 1500 mg/day
Raz, 200850
Multinational
Fair
190
18, 30
53.6–56.1 (9.5)
49.0–58.5
42–47
25–32
9.2d
200
Sitagliptin 100 mg or Placebo
Added to metformin > 1500 mg/day
Vilsboll, 201051
Multinational
Fair
641
24
57.2–58.3 (9.1–9.3)
47–51
69–71
12–16
8.6–8.7 (0.9)
86.5–87.3(17.9–18.6)
Sitagliptin
Placebo Added to insulin (>15 units/day) ± metformin (>1500 mg/day)
Chan, 200837
Multinational
Fair
91
12, 54
65.3–68.9 (9.7–9.8)
38–52
31–34
26–35
7.6–7.8 (0.9)
68.3–71.5 (14.0–16.5)
Sitagliptin 25 mg daily or 50 mg daily
Placebo /glipizide

Abbreviation: NR, not reported.

a

Data presented are the range across treatment groups for mean and standard deviation.

b

>50% had HbA1c <8% at baseline.

c

> 30% had HbA1c <8% at baseline; means are reported as standard deviation unless otherwise specified.

d

>50% had HbA1c >9% at baseline.

e

Glipizide added to placebo group after 12 weeks for remaining 42 weeks. Sitagliptin dose determined by renal function. Patients could be on insulin, number not reported.

From: Results

Cover of Drug Class Review: Newer Diabetes Medications, TZDs, and Combinations
Drug Class Review: Newer Diabetes Medications, TZDs, and Combinations: Final Original Report [Internet].
Jonas D, Van Scoyoc E, Gerrald K, et al.
Portland (OR): Oregon Health & Science University; 2011 Feb.
Copyright © 2011, Oregon Health & Science University.

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