Table 6

Characteristics of pramlintide placebo-controlled trials in adults with type 2 diabetes

Author, year
Country
Quality
Sample size (N)
Follow- up (weeks)
Age (years) (SD)a
% Malea
% Whitea %
Hispanica
Diabetes duration (years)a
Baseline
A1c (%) (SD)a
Weight (kg)a
BMI (kg/m2)a
Total daily insulin dose (units)
Glycemic goals prespecified?
Intervention DosagesCombination therapy
Ratner, 200217
US
Fair-Poor
538/538
52
55.5–57.5 (8.9–10.8)
56–62
76–81
8–10
11.3–13.3 (7.0–7.8)
9.0–9.3 (1.1–1.2)
NR
30.4–31.1 (4.7–5.5)
55.1–60.6 (26.5–29.2)
NR
Pram: 30 mcg
75 mcg, 150 mcg TID, before meals + insulin ± OHA

Insulin: Dose adjustments not encouraged (fixed-stable dosing)
Stable doses of MET or SU were allowed; doses to remain unchanged
Hollander, 200316
US
Fair
656/498
52
56.4–57.0 (10.2–10.5)
48–52
73–77
8–13
12.0–12.4 (6.6–7.3)
9.0–9.3 (1.1–1.3)
96.7–97.1 (19.3–23.2)
33.7–34.1 (6.3–7.5)
69–74
NR
Pram: 60 mcg TID, 90 mcg, 120 mcg BID, before meals +insulin± OHA

Insulin: Dose adjustment not encouraged (fixed-stable dosing)

Note: 60 mcg arm was excluded after another trial indicated that this dose was less effective than higher doses
Stable doses of MET or SU were allowed; doses to remain unchanged
Riddle, 200718
US
Fair
212/211
16
55 (9–10)
45.7–51.9
72–73
8–13
12.0–12.4 (6.6–7.3)
8.5 (0.9)
103 (18)
35 (5–6)
48–54 (25–42)
Yes
Pram: 60 mcg, 120 mcg, BID-TID +glargine ± OHA

Insulin: Glargine only; flexible dosing; titrate to goals
Stable doses of MET, SU, +/−TZD were allowed
a

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

Abbreviations: Pram, pramlintide; NR, not reported; OHA, oral hypoglycemic agents; SU, sulfonylureas; MET, metformin; TZD, thiazolidinediones; BID, twice daily; TID, three times daily.

From: Results

Cover of Drug Class Review: Newer Drugs for the Treatment of Diabetes Mellitus
Drug Class Review: Newer Drugs for the Treatment of Diabetes Mellitus: Final Report [Internet].
Norris SL, Lee NJ, Severance S, et al.
Portland (OR): Oregon Health & Science University; 2008 Aug.
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.

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