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Table 7Characteristics of pramlintide trials (placebo and active controlled) 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 DosagesBackground therapy
Ratner, 200226
US
Fair
538/538
52
55.5–57.5 (8.9–10.8)
38–44
76–81
8–10
9.0–9.3 (1.1–1.2)
NR
Pramlintide: 30 mcg, 75 mcg, 150 mcg TIDb

Placebo + Insulin:
Dose adjustments not encouraged (fixed-stable dosing)
Stable doses of MET or SU were allowed; doses to remain unchanged
Hollander, 200325
US
Fair
656/498
52
56.4–57.0 (10.2–10.5)
48–52
73–77
8–13
9.0–9.3 (1.1–1.3)
96.7–97.1 (19.3–23.2)
Pram: 60 mcg TID, 90 mcg, 120 mcg BIDb

Placebo + Insulin:
Dose adjustments not encouraged (fixed-stable dosing)c
Stable doses of MET or SU were allowed; doses to remain unchanged
Riddle, 2007,24
Wysham, 200823d
US
Fair
212/211
16
48.1–54.3
55 (9–10)
72–73
8–13
8.5 (0.9)
103 (18)
Pram: 60 mcg, 120 mcg, BID-TIDe

Placebo + insulin glargine: dose adjustments allowed
Stable doses of MET, SU, +/− TZD were allowed
Riddle, 200922
US
Fair
113/112
24
54–55(10–11)
34–39.3
NR
NR
8.2–8.3(0.8)
103–108(18–22)
Pram: 120 mcg before major meals

Rapid-acting insulin analog: 5 units before meals, titrated every 3–7 days
Insulin glargine or detemir, oral antihyerpglyce mics were allowed

Abbreviations: BID, 2 times per day; BMI, body mass index; MET, metformin, NR, not reported; Pram, Pramlintide; SD, standard deviation; SU, sulfonylurea, TID, 3 times per day.

a

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

b

Pramlintide was administered before meals + insulin or insulin glargine ± oral hypoglycemic agent.

c

Note: 60 mcg arm was excluded after another trial indicated that this dose was less effective than higher doses

d

Wysham, 2008 is a post hoc analysis of Riddle. To avoid duplication, the data are not presented here.

e

Pramlintide was administered with insulin glargine ± oral hypoglycemic agent.

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

Pramlintide was administered before meals + insulin or insulin glargine ± oral hypoglycemic agent.

Note: 60 mcg arm was excluded after another trial indicated that this dose was less effective than higher doses

Wysham, 2008 is a post hoc analysis of Riddle. To avoid duplication, the data are not presented here.

Pramlintide was administered with insulin glargine ± oral hypoglycemic agent.

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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