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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03770637
Other study ID # XSGR-PBH-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 10, 2019
Est. completion date February 26, 2020

Study information

Verified date May 2020
Source Xeris Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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Study Design


Intervention

Drug:
Glucagon RTU
Glucagon RTU is a sterile subcutaneous injectable non-aqueous solution formulation supplied in a vial and administered via syringe.
Other:
Placebo
The placebo is a non-active version of Glucagon RTU formulation, containing the same solvent and excipients (i.e., vehicle).

Locations

Country Name City State
United States University of Colorado-Denver Aurora Colorado
United States Johns Hopkins Hospital Baltimore Maryland
United States Joslin Diabetes Center Boston Massachusetts
United States Duke Early Phase Clinical Research Durham North Carolina
United States Mayo Clinic- Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Xeris Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood glucose recovery: CRC Number of subjects with blood glucose > 70 mg/dL At 15 minutes following administration of study drug
Primary Blood glucose recovery: Out-patient Frequency of blood glucose > 70 mg/dL At 15 minutes following administration of study drug
Secondary Symptomatic Recovery: CRC Change from Baseline in Hypoglycemia Symptoms At 15, 30, and 60 minutes following administration of study drug
Secondary Incidence of severe hypoglycemia: CRC Number of subjects requiring external assistance to treat hypoglycemia At 0-240 minutes following administration of study drug
Secondary Incidence of severe hypoglycemia: Out-patient Frequency of external assistance to treat postprandial hypoglycemia During 12 weeks of out-patient treatment
Secondary Incidence of serious hypoglycemia: CRC Number of subjects with blood glucose < 54 mg/dL At 0-240 minutes following administration of study drug
Secondary Incidence of serious hypoglycemia: Out-patient Frequency of postprandial blood glucose < 54 mg/dL During 12 weeks of out-patient treatment
Secondary 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. During 12 weeks of out-patient treatment
Secondary 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. During 12 weeks of out-patient treatment
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