Table 5Characteristics of pramlintide placebo-controlled trials in adults with type 1 diabetes

Author, year
Country
Quality
Sample size (N)
Follow-up (weeks)
Age (years)(SD)a
% Malea
% Whitea
% Hispanica
Baseline values:
HbA1c (%) (SD)a
Weight (kg)a
Interventions
Whitehouse, 200219
US
Fair
480/342
52
40.3–40.4 (11.6–12.1)
55
92–96
NR
8.7–8.9 (1.3–1.5)
75.0–75.6 (13.8–13.3)
Pramlintide: 30 mcg, 60 mcg QIDb

Placebo + Insulin: No restrictions on use (flexible dosing)
Ratner, 200421
US, Canada
Fair
651/479
52
39.2–41.9 (12.8–13.6)
47–53
89–92
NR
8.9–9.0 (0.9–1.1)
75.8–78.3 (14.5–15.8)
Pramlintide: 60 mcg TID, 60 mcg QID, 90 mcg TIDb,c

Placebo + Insulin: Dose adjustments not encouraged (fixed-stable dosing)
Edelman, 200620
US
Fair
296/295
29
41 (12–14)
36.6–53.5
85.4–92
NR
8.1–8.2 (0.7–0.8)
77–83 (13–18)
Pramlintide: 30 mcg, 60 mcg, TID-QIDb

Placebo + Insulin: No restrictions on use (flexible dosing)

Abbreviations: BMI, body mass index; NR, not reported; SD, standard deviation; TID, 3 times daily; QID, 4 times daily.

a

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

b

Pramlintide was administered before meals with insulin.

c

Efficacy results from 90 mcg arm were excluded after another trial indicated that this dose exhibited an adverse tolerability profile.

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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