Table 1.

Study Eligibility Criteria

ComponentDescription
FDA = Food and Drug Administration; HbA1c=glycated hemoglobin.
PopulationAdults and children with type 1 or type 2 diabetes
InterventionPramlintide for FDA- and non-FDA-approved indications
Compared agentOther hypoglycemic agent or placebo
Long-term health outcomesAll-cause mortality, micro- or macrovascular disease, quality of life, complications related to diabetes
Intermediate outcomesGlycemic control: HbA1c, fasting plasma glucose, postprandial glucose; change in weight; time to treatment failure
Harms-related outcomesWithdrawals due to all causes, withdrawals due to adverse events, overall adverse events, major adverse events
Study designFor efficacy/effectiveness: randomized controlled clinical trials, good-quality systematic reviews
 For harms and subgroups: randomized controlled clinical trials, good-quality systematic reviews, population-based comparative cohort or case-control studies
ExcludedTrials <12 weeks’ duration; abstracts, posters, and conference proceedings with limited information for quality assessment