Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes Mellitus; Pramlintide
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 34
Healthy volunteers: no

Brief summary:
This study is designed to investigate the clinical efficacy and safety of pramlintide co-administered as a fixed-dose ratio with basal-bolus SC insulin, delivered simultaneously via 2 separate pumps, in subjects with type 1 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.

Detailed description:
Potentially eligible subjects with Type 1 diabetes mellitus who are treated with with a basal-bolus insulin regimen through multiple daily injections or insulin pump at a total daily insulin dose ≤60 U, will be eligible. Visit 1 is approximately 3-6 weeks prior to randomization. Given some variability in HbA1c and C-peptide assays, re-testing for HbA1c and C-peptide can be performed within 18 days from the initial visit. Visit 2 is approximately 2-5 weeks prior to randomization. Subjects are on lispro insulin throughout study except during Visit 4 and Visit 5, the domicile 24 hr treatment period, when they are switched to regular insulin U-100.

Screen failed patients may be re-screened for inclusion in the study, as long as re-screening takes place at least 3 months after the original screening visit. If a subject is re-screened, he/she must continue to meet all inclusion/exclusion criteria. All study procedures of initial Visit 1 must be repeated at the re-screening visit.

Arms:
arm 1: Pramlintide will be adiministered by sc infusion at a concentration of 1000ug/mL arm 2: Placebo is similar sterile solution without pramlintide.

Interventions: intervention 1: Pramlintide acetate intervention 2: Placebo intervention 3: Lispro insulin U-100 intervention 4: Regular insulin U-100
Intervention descriptions: intervention 1: Pramlintide acetate administered by a separate pump intervention 2: Placebo administered by separate pump intervention 3: Subjects will be stabilized on a separate insulin pump and administered lispro insulin throughout the study, except during both inpatient treatment periods (Visit 4 and Visit 5) intervention 4: Use during two in-patient treatment periods (visits 4 and 5) and administered by separate pump

Protocol document: