HypoglycemiaPhase 2NCT04824872
Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults
A Phase 2 study testing Dasiglucagon in people with Hypoglycemia and Glucose Metabolism Disorders, run by Zealand Pharma.
Trial summary
The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypoglycemia, Glucose Metabolism Disorders
- What is being tested?
- Dasiglucagon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Feb 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously undergone Roux-en-Y gastric bypass (RYGB) surgery at least 6 months prior to screening
- Previous diagnosis of post-bariatric hypoglycemia (PBH), requiring intake of oral carbohydrates.
- Body mass index (BMI) ≤ 40 kg/m2
- Fasting plasma glucose between 72-106 mg/dL (4.0-6.0 mmol/l)
Who cannot join
- History of hypersensitivity reactions to glucagon or dasiglucagon or any of the excipients
- History of insulinoma, pheochromocytoma, MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease.
- Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2 or end-stage renal disease at screening
- Hepatic disease, including serum alanine aminotransferase or aspartate aminotransferase ≥ 2.5 times the upper limit of normal (ULN)
- Active malignancy, except for basal or squamous cell skin cancers
- History of a cerebrovascular accident within 6 months prior to screening
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- History of myocardial infarction, unstable angina, or revascularization within 6 months prior to screening.
- Congestive heart failure, New York Heart Association Class III or IV
- Concurrent administration of β-blocker therapy
- Clinically significant ECG abnormalities at screening
About this study
Official title: A Double-Blind, Placebo-Controlled, Cross-over Trial, Evaluating Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults
The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects
- Conditions
- Hypoglycemia, Glucose Metabolism Disorders
- Being tested
- Dasiglucagon, Placebo
- Medical subject headings
- Hypoglycemia, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasiglucagonDrug
dasiglucagon SC, low dose
DasiglucagonDrug
dasiglucagon SC, high dose
PlaceboDrug
placebo for dasiglucagon
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Dasiglucagon high dose, followed by placebo, followed by dasiglucagon low dose Receives: Drug: Dasiglucagon; Drug: Placebo |
| Sequence 2 | Experimental | Dasiglucagn low dose, followed by dasiglucagon high dose, followed by placebo Receives: Drug: Dasiglucagon; Drug: Placebo |
| Sequence 3 | Experimental | Placebo, followed by dasiglucagon low dose, followed by dasiglucagon high dose Receives: Drug: Dasiglucagon; Drug: Placebo |
| Sequence 4 | Experimental | Dasiglucagon high dose, followed by dasiglucagon low dose, followed by placebo Receives: Drug: Dasiglucagon; Drug: Placebo |
| Sequence 5 | Experimental | Placebo, followed by dasiglucagon high dose, followed by dasiglucagn low dose Receives: Drug: Dasiglucagon; Drug: Placebo |
| Sequence 6 | Experimental | Dasiglucagon low dose, followed by placebo, followed by dasiglucagon high dose Receives: Drug: Dasiglucagon; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nadir plasma glucose concentration
Measured: From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Secondary outcomes (4)
Percent time spent in hypoglycemia
Defined as time with a plasma glucose value of 70 mg/dL (3.9 mmol/L) or less
Measured: From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Percent time spent in clinical significant hypoglycemia
Defined as time with a plasma glucose value of 54 mg/dL (3.0 mmol/L) or less
Measured: From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Percent time spent in target range
Defined as time with a plasma glucose value of 70-180 mg/dL (3.9-10.0 mmol/L)
Measured: From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Percent time spent in hyperglycemia
Defined as time with a plasma glucose value >180 mg/dL (>10 mmol/l)
Measured: From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study startFeb 2023 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Why it stopped: Never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824872
- Sponsor's protocol ID
- ZP4207-20123
- Status last verified
- Feb 2023
- First submitted
- 29 Mar 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Cross-over Trial, Evaluating Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults
- ClinicalTrials.gov ID
- NCT04824872
- Acronym / sponsor ID
- ZP4207-20123
- Conditions
- Hypoglycemia, Glucose Metabolism Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2023 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 1 Apr 2021 (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.
The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Dasiglucagon, Drug: PlaceboDasiglucagon high dose, followed by placebo, followed by dasiglucagon low dose |
| Sequence 2 | Experimental | Drug: Dasiglucagon, Drug: PlaceboDasiglucagn low dose, followed by dasiglucagon high dose, followed by placebo |
| Sequence 3 | Experimental | Drug: Dasiglucagon, Drug: PlaceboPlacebo, followed by dasiglucagon low dose, followed by dasiglucagon high dose |
| Sequence 4 | Experimental | Drug: Dasiglucagon, Drug: PlaceboDasiglucagon high dose, followed by dasiglucagon low dose, followed by placebo |
| Sequence 5 | Experimental | Drug: Dasiglucagon, Drug: PlaceboPlacebo, followed by dasiglucagon high dose, followed by dasiglucagn low dose |
| Sequence 6 | Experimental | Drug: Dasiglucagon, Drug: PlaceboDasiglucagon low dose, followed by placebo, followed by dasiglucagon high dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previously undergone Roux-en-Y gastric bypass (RYGB) surgery at least 6 months prior to screening
- Previous diagnosis of post-bariatric hypoglycemia (PBH), requiring intake of oral carbohydrates.
- Body mass index (BMI) ≤ 40 kg/m2
- Fasting plasma glucose between 72-106 mg/dL (4.0-6.0 mmol/l)
Key exclusion criteria (10 listed)
- History of hypersensitivity reactions to glucagon or dasiglucagon or any of the excipients
- History of insulinoma, pheochromocytoma, MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease.
- Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2 or end-stage renal disease at screening
- Hepatic disease, including serum alanine aminotransferase or aspartate aminotransferase ≥ 2.5 times the upper limit of normal (ULN)
- Active malignancy, except for basal or squamous cell skin cancers
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 |
|---|---|---|
| Dasiglucagondasiglucagon SC, low dose | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| Dasiglucagondasiglucagon SC, high dose | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| Placeboplacebo for dasiglucagon | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Nadir plasma glucose concentration
Time frame: From trial drug administration to 240 minutes after initiation of Mixed Meal Test
4 secondary outcomes
Percent time spent in hypoglycemia
Time frame: From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Percent time spent in clinical significant hypoglycemia
Time frame: From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Percent time spent in target range
Time frame: From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Percent time spent in hyperglycemia
Time frame: From trial drug administration to 240 minutes after initiation of Mixed Meal Test
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasiglucagon in people with Hypoglycemia and Glucose Metabolism Disorders, run by Zealand Pharma.
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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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?
Nadir plasma glucose concentration (time frame: From trial drug administration to 240 minutes after initiation of Mixed Meal Test). 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 Feb 2023.