This is a double-blind, placebo-controlled Phase 2 study to assess the efficacy, safety and tolerability of Glucagon RTU when administered to subjects with a history of bariatric surgery during episodes of post-postprandial hypoglycemia. Twelve eligible subjects will be randomly assigned to receive Glucagon RTU or placebo at the first of two clinical research center (CRC) visits, followed by the other treatment at the second CRC visit. Subjects will be randomly assigned to either Glucagon RTU or Placebo for the duration of a 12-week Outpatient Stage. A follow-up safety assessment visit will occur 14 to 28 days after a subject's last dose of study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
14
Glucagon RTU is a sterile subcutaneous injectable non-aqueous solution formulation supplied in a vial and administered via syringe.
The placebo is a non-active version of Glucagon RTU formulation, containing the same solvent and excipients (i.e., vehicle).
University of Colorado-Denver
Aurora, Colorado, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Mayo Clinic- Rochester
Rochester, Minnesota, United States
Duke Early Phase Clinical Research
Durham, North Carolina, United States
Blood glucose recovery: CRC
Number of subjects with blood glucose \> 70 mg/dL
Time frame: At 15 minutes following administration of study drug
Blood glucose recovery: Out-patient
Frequency of blood glucose \> 70 mg/dL
Time frame: At 15 minutes following administration of study drug
Symptomatic Recovery: CRC
Change from Baseline in Hypoglycemia Symptoms
Time frame: At 15, 30, and 60 minutes following administration of study drug
Incidence of severe hypoglycemia: CRC
Number of subjects requiring external assistance to treat hypoglycemia
Time frame: At 0-240 minutes following administration of study drug
Incidence of severe hypoglycemia: Out-patient
Frequency of external assistance to treat postprandial hypoglycemia
Time frame: During 12 weeks of out-patient treatment
Incidence of serious hypoglycemia: CRC
Number of subjects with blood glucose \< 54 mg/dL
Time frame: At 0-240 minutes following administration of study drug
Incidence of serious hypoglycemia: Out-patient
Frequency of postprandial blood glucose \< 54 mg/dL
Time frame: During 12 weeks of out-patient treatment
Hypoglycemia Fear Scale
Change from Baseline in Hypoglycemia Fear Scale (HFS-2) Scores. The HFS-2 consists of two domains, Behavior, which has 15 questions, and Worry, which has 18 questions. Each question is assessed on a 5-point scale from 0=Never to 4=Almost Always. Lower scores indicate less fear of hypoglycemia, while higher scores indicate a greater level of fear.
Time frame: During 12 weeks of out-patient treatment
EuroQol Health Questionnaire (EQ-5D)
Change from Baseline in EQ-5D Score. This is a health assessment questionnaire with three domains. The first two domains of pain/discomfort and anxiety/depression are scored on a 5-point scale from 1=no pain/discomfort; not anxious or depressed to 5=extreme pain or discomfort; extremely anxious or depressed. For these two domains, lower scores indicate less pain/discomfort or anxiety/depression, while higher scores indicate increasing levels of pain/discomfort or anxiety/depression. The third domain of Health is assessed with a series of 5 visual analog scales, each scored from 0-100. On these VAS scales, high scores indicate better health, while low scores indicate worse health.
Time frame: During 12 weeks of out-patient treatment
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