Hyperinsulinemic HypoglycemiaPhase 2NCT03770637
Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
A Phase 2 study testing Glucagon RTU in people with Hyperinsulinemic Hypoglycemia, run by Xeris Pharmaceuticals at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperinsulinemic Hypoglycemia
- What is being tested?
- Glucagon RTU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 May 2019to 26 Feb 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Aged 18 to 75 years of age, inclusive
- Symptoms of hypoglycemia that developed after bariatric surgery (Roux-en-Y gastric bypass [RYGB] only) in the absence of antidiabetic medications
- History of bariatric surgery (RYGB only), at least 6 months prior to screening
- Whipple's triad
- Ability to both experience and recognize hypoglycemic awareness.
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- Documented glucose levels < 54 mg/dL when experiencing symptoms suggestive of hypoglycemia
- Relief of hypoglycemia symptoms when the glucose is raised to normal
- Diagnosis of post-bariatric hypoglycemia (PBH) by a physician, requiring intervention such as intake of oral carbohydrates. This diagnosis includes documentation of endogenous hyperinsulinism in the presence of low plasma glucose.
- In subjects with medical history of diabetes, medical documentation of postoperative remission of diabetes mellitus (fasting glucose < 110 mg/dL), and HbA1c < 6% (or 42 mmol/mL) with all previous antidiabetic medication discontinued for at least 6 months before screening.
- Body mass index (BMI) ≤ 40 kg/m2
- Willingness to follow all study procedures, including attending all clinic visits and self-administering blinded study drug at home for 12 weeks
- Understands the study procedures, alternative treatment available, and risks involved with the study, and he/she voluntarily agrees to participate by giving written informed consent
- Women of childbearing potential must have a negative urine pregnancy test and agree to use contraception and refrain from breast-feeding during the study and for at least 15 days after participating in the study.
Who cannot join
- Documented hypoglycemia occurring in the fasting state (> 12 hours fast) within 12 months of study entry
- Hypoglycemic unawareness as evidenced by a Gold Scale score > 4 at screening
- Early Dumping Syndrome
- Known insulinoma or adrenal insufficiency
- Active treatment with any insulin/insulin secretagogues, or other diabetes medications except for acarbose and glucagon-like peptide 1 (GLP-1) analogues
- Chronic kidney disease Stage 4 or 5 or an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2 at screening
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- Hepatic disease, including serum alanine aminotransferase or aspartate aminotransferase ≥ 3 times the upper limit of normal (ULN); hepatic synthetic insufficiency as defined as serum albumin < 3.0 g/dL
- Congestive heart failure, New York Heart Association Class III or IV
- History of myocardial infarction, unstable angina, or revascularization within 6 months prior to screening.
- History of a cerebrovascular accident within 6 months prior to screening or with major neurological deficits
- Seizure disorder (other than with suspected or documented hypoglycemia).
- Active malignancy, except for basal or squamous cell skin cancers
- Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease)
- Major surgical operation within 30 days prior to screening
- Hematocrit ≤ 30%
- Bleeding disorder, treatment with warfarin, or platelet count < 50,000 /mm3
- Active alcohol abuse or substance abuse (per investigator assessment)
- Current chronic administration of oral or parenteral corticosteroids, however topical, intraarticular, and inhaled corticosteroids are allowed
- Use of an investigational drug within 15 days or 5 half-lives, whichever is longer, prior to screening
- Member of a special vulnerable populations such as pregnant women, prisoners, institutionalized or incarcerated individuals, or others who may be considered vulnerable
- Any other medical condition or finding that in the opinion of the investigator or sponsor, would compromise the safety of the subject or compromise the integrity of the study data
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado-Denver
Aurora, Colorado, 80045
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Joslin Diabetes Center
Boston, Massachusetts, 02215
Duke Early Phase Clinical Research
Durham, North Carolina, 27701
Mayo Clinic- Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Phase 2, Interventional, Randomized, Double-Blind, Placebo-Controlled Pilot Study of Glucagon RTU in Subjects Who Experience Hyperinsulinemic Hypoglycemia After Bariatric Surgery
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.
- Conditions
- Hyperinsulinemic Hypoglycemia
- Being tested
- Glucagon RTU, Placebo
- Keywords
- glucagon, post-bariatric hypoglycemia
- Medical subject headings
- Congenital Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon RTUDrug
Also called glucagon
Glucagon RTU is a sterile subcutaneous injectable non-aqueous solution formulation supplied in a vial and administered via syringe.
PlaceboOther
The placebo is a non-active version of Glucagon RTU formulation, containing the same solvent and excipients (i.e., vehicle).
| Study group | Role | What they receive |
|---|---|---|
| Glucagon RTU (glucagon injection) | Experimental | Glucagon Ready-to-Use (RTU); 60 μL injection (0.3 mg glucagon) Receives: Drug: Glucagon RTU |
| Placebo | Placebo comparator | Non-active vehicle for Glucagon RTU; 60 μL injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose recovery: CRC
Number of subjects with blood glucose > 70 mg/dL
Measured: At 15 minutes following administration of study drug
Blood glucose recovery: Out-patient
Frequency of blood glucose > 70 mg/dL
Measured: At 15 minutes following administration of study drug
Secondary outcomes (7)
Symptomatic Recovery: CRC
Change from Baseline in Hypoglycemia Symptoms
Measured: 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
Measured: At 0-240 minutes following administration of study drug
Incidence of severe hypoglycemia: Out-patient
Frequency of external assistance to treat postprandial hypoglycemia
Measured: During 12 weeks of out-patient treatment
Incidence of serious hypoglycemia: CRC
Number of subjects with blood glucose < 54 mg/dL
Measured: At 0-240 minutes following administration of study drug
Incidence of serious hypoglycemia: Out-patient
Frequency of postprandial blood glucose < 54 mg/dL
Measured: 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.
Measured: 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.
Measured: During 12 weeks of out-patient treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start10 May 2019
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperinsulinemic HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, placebo-controlled, double-blind, two-treatment, 2-period, crossover in-patient phase followed by a placebo-controlled, double-blind, parallel two-treatment outpatient stage..
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xeris Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770637
- Sponsor's protocol ID
- XSGR-PBH-201
- Status last verified
- May 2020
- First submitted
- 7 Dec 2018
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Interventional, Randomized, Double-Blind, Placebo-Controlled Pilot Study of Glucagon RTU in Subjects Who Experience Hyperinsulinemic Hypoglycemia After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03770637
- Acronym / sponsor ID
- XSGR-PBH-201
- Conditions
- Hyperinsulinemic Hypoglycemia
- Keywords
- glucagon, post-bariatric hypoglycemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Xeris PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 May 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized, placebo-controlled, double-blind, two-treatment, 2-period, crossover in-patient phase followed by a placebo-controlled, double-blind, parallel two-treatment outpatient stage..
| Arm | Type | Receives |
|---|---|---|
| Glucagon RTU (glucagon injection) | Experimental | Drug: Glucagon RTUGlucagon Ready-to-Use (RTU); 60 μL injection (0.3 mg glucagon) |
| Placebo | Placebo comparator | Other: PlaceboNon-active vehicle for Glucagon RTU; 60 μL injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female
- Aged 18 to 75 years of age, inclusive
- Symptoms of hypoglycemia that developed after bariatric surgery (Roux-en-Y gastric bypass [RYGB] only) in the absence of antidiabetic medications
- History of bariatric surgery (RYGB only), at least 6 months prior to screening
- Whipple's triad
Key exclusion criteria (21 listed)
- Documented hypoglycemia occurring in the fasting state (> 12 hours fast) within 12 months of study entry
- Hypoglycemic unawareness as evidenced by a Gold Scale score > 4 at screening
- Early Dumping Syndrome
- Known insulinoma or adrenal insufficiency
- Active treatment with any insulin/insulin secretagogues, or other diabetes medications except for acarbose and glucagon-like peptide 1 (GLP-1) analogues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucagon RTUAlso: glucagonGlucagon RTU is a sterile subcutaneous injectable non-aqueous solution formulation supplied in a vial and administered via syringe. | Drug | Glucagon RTU (glucagon injection) |
| PlaceboThe placebo is a non-active version of Glucagon RTU formulation, containing the same solvent and excipients (i.e., vehicle). | Other | Placebo |
Primary outcome
Blood glucose recovery: CRC
Time frame: At 15 minutes following administration of study drug
Number of subjects with blood glucose > 70 mg/dL
Blood glucose recovery: Out-patient
Time frame: At 15 minutes following administration of study drug
Frequency of blood glucose > 70 mg/dL
7 secondary outcomes
Symptomatic Recovery: CRC
Time frame: At 15, 30, and 60 minutes following administration of study drug
Incidence of severe hypoglycemia: CRC
Time frame: At 0-240 minutes following administration of study drug
Incidence of severe hypoglycemia: Out-patient
Time frame: During 12 weeks of out-patient treatment
Incidence of serious hypoglycemia: CRC
Time frame: At 0-240 minutes following administration of study drug
Incidence of serious hypoglycemia: Out-patient
Time frame: During 12 weeks of out-patient treatment
Hypoglycemia Fear Scale
Time frame: During 12 weeks of out-patient treatment
EuroQol Health Questionnaire (EQ-5D)
Time frame: During 12 weeks of out-patient treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glucagon RTU in people with Hyperinsulinemic Hypoglycemia, run by Xeris Pharmaceuticals at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose recovery: CRC (time frame: At 15 minutes following administration of study drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.