N/A N=10 Randomized Health Services Research

Pramlintide in Adolescents With Type 1 Diabetes

Type 1 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT00842075 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Oct 2012

Primary outcome: Primary: HbA1c Value After 28 Days — 7.94; 8.72 HbA1c %

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: pramlintide (Drug)
Age: Pediatric · 13+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY HbA1c Value After 28 Days	7.94; 8.72	—
SECONDARY Weight Change After 28 Days Intervention Period	-0.84; 0.04	—

Summary

The investigators hypothesize that subcutaneous pramlintide as an adjunct to mealtime insulin immediately prior to meals can significantly reduce post-prandial glucose concentrations compared with mealtime insulin alone in children with type 1 diabetes. This is a 36 day, randomized, two-arm, open-label study with a treatment arm (taking pramlintide before all meals) and a control arm (diabetes regimen as usual).

Eligibility Criteria

Inclusion Criteria

Between 13 and 17 years of age, inclusive
Diagnosed with type 1 diabetes for > 1 year
Hemoglobin A1c between 7.5 and 10% inclusive
Currently using carbohydrate to insulin ratio
Acceptable form of birth control

Exclusion Criteria

Use of oral hyperglycemic agents or medications affecting blood sugar levels
Recurrent severe hypoglycemia requiring assistance in past 6 months
History of hypoglycemia unawareness
History of gastroparesis requiring use of drugs that stimulate gastrointestinal motility
Previous use of pramlintide

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00842075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.