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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT03770637
Study groupRoleWhat they receive
Glucagon RTU (glucagon injection)ExperimentalGlucagon Ready-to-Use (RTU); 60 μL injection (0.3 mg glucagon)
Receives: Drug: Glucagon RTU
PlaceboPlacebo comparatorNon-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.

  1. Blood glucose recovery: CRC

    Number of subjects with blood glucose > 70 mg/dL

    Measured: At 15 minutes following administration of study drug

  2. Blood glucose recovery: Out-patient

    Frequency of blood glucose > 70 mg/dL

    Measured: At 15 minutes following administration of study drug

Secondary outcomes (7)

  1. Symptomatic Recovery: CRC

    Change from Baseline in Hypoglycemia Symptoms

    Measured: At 15, 30, and 60 minutes following administration of study drug

  2. Incidence of severe hypoglycemia: CRC

    Number of subjects requiring external assistance to treat hypoglycemia

    Measured: At 0-240 minutes following administration of study drug

  3. Incidence of severe hypoglycemia: Out-patient

    Frequency of external assistance to treat postprandial hypoglycemia

    Measured: During 12 weeks of out-patient treatment

  4. Incidence of serious hypoglycemia: CRC

    Number of subjects with blood glucose < 54 mg/dL

    Measured: At 0-240 minutes following administration of study drug

  5. Incidence of serious hypoglycemia: Out-patient

    Frequency of postprandial blood glucose < 54 mg/dL

    Measured: During 12 weeks of out-patient treatment

  6. 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

  7. 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.

  1. First posted10 Dec 2018
  2. Study start10 May 2019
  3. Primary completion26 Feb 2020
  4. Study completion26 Feb 2020

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT03770637.

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.

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