Hyperinsulinemic HypoglycemiaPhase 2SHERRYNCT04836273
Treatment of Post-bariatric Hypoglycaemia
A Phase 2 study testing Dasiglucagon and HyoPen in people with Hyperinsulinemic Hypoglycemia and Postprandial Hypoglycemia, run by Filip Krag Knop at 1 site in Denmark.
Trial summary
This is an investigator-initiated, proof-of-concept, randomised, double-blind, placebo-controlled, single-centre phase II study aiming to evaluate the efficacy, safety and tolerability of self-administered subcutaneous 120 µg dasiglucagon with an investigational trial device (i.e. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperinsulinemic Hypoglycemia, Postprandial Hypoglycemia
- What is being tested?
- Dasiglucagon and HyoPen
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Aug 2021to 15 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Documented postprandial hypoglycaemia (IG <3.9 mmol/l, ≥3 times/week) assessed by 14-days of blinded CGM recording
- Haemoglobin levels for women >7.3 mmol/l and for men >8.3 mmol/l
- Ferritin >10 μg/l
- Cobalamin >150 pmol/l
- Fasting plasma glucose concentration within the range of 4.0-6.0 mmol/l
- Normal electrocardiogram (ECG)
- Negative urine human chorionic gonadotropin (hCG) (for fertile women)
Who cannot join
- Treatment with medication(s) affecting insulin secretion, glucose metabolism or any antidiabetic drugs
- Treatment with antipsychotics
- Current participation in another clinical trial with administration of investigational drug
- Previous exposure to dasiglucagon (also known as ZP4207) within the last 30 days prior screening
- History of liver disease that is expected to interfere with the anti-hypoglycaemic action of glucagon (e.g. liver failure or cirrhosis)
- Pregnancy
Show all 13Show fewer
- Breastfeeding
- Major surgery within 30 days before screening
- Alcohol abuse (per investigator assessment)
- Any factors that, in the opinion of the site principal investigator or clinical protocol chair, would interfere with the safe completion of the study, including medical conditions that may require hospitalization during the trial
- History of pheochromocytoma or insulinoma
- History of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients
- Known or suspected allergies to glucagon or related products
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Clinical Metabolic Research, Herlev-Gentofte Hospital
Hellerup, 2900
About this study
Official title: Ready-to-use Dasiglucagon for the Treatment of Postprandial Hypoglycaemia in Roux-en-Y Gastric Bypass Operated Patients
This is an investigator-initiated, proof-of-concept, randomised, double-blind, placebo-controlled, single-centre phase II study aiming to evaluate the efficacy, safety and tolerability of self-administered subcutaneous 120 µg dasiglucagon with an investigational trial device (i.e. a multi-dose reusable pen) for the treatment of postprandial hypoglycaemia after Roux-en-Y gastric bypass (RYGB) surgery. The study is divided into an in-patient and out-patient part.
The primary aim of the study is to compare the effects of self-administered 120 µg dasiglucagon versus placebo on continuous glucose monitoring (CGM)-assessed time spent in hypoglycaemia in RYGB-operated individuals in an out-patient setting.
Read the detailed description
Study design:
Before inclusion in the study, the participants will complete a screening visit and a blinded 14-day continuous glucose monitoring (CGM) run-in period to ascertain a regular occurrence of postprandial hypoglycaemia (IG <3.9 mmol/l, ≥3 times/week). After enrolment in the study, the participants will wear a CGM for the entirety of the study period (apart from the four weeks before the follow-up visit). Prior to the first mixed meal test (MMT) during the in-patient part, the subjects will be randomised into one of four double-blinded treatment sequences consisting of an in-patient part (two MMTs) follow by a nine weeks out-patient part (two times four weeks per out-patient part with an interposed washout period of one week) and ended with a follow-up visit four weeks after out-patient part completion.
During the in-patient part, the participants will undergo two separate MMTs, with a minimum of 7 days in-between, accompanied by one of the following double-blind, randomised, placebo-controlled crossover interventions:
- Subcutaneous placebo self-administration
- Subcutaneous 120 µg dasiglucagon self-administration
The out-patient part is divided into two double-blinded, randomised, placebo-controlled crossover out-patient parts with of the following interventions:
- Subcutaneous placebo self-administration
- Subcutaneous 120 µg dasiglucagon self-administration
- Being tested
- Dasiglucagon, HyoPen, Placebo
- Medical subject headings
- Congenital Hyperinsulinism, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasiglucagonDrug
Also called ZP4207
Abdominal s.c. self-administration 120 µg of dasiglucagon when blood glucose levels are below 3.9 mmol/L or interstitial glucose levels below 3.5 mmol/L. The frequency of the intervention is approximately once a day.
HyoPenDevice
Also called Zealand Pen
multi-dose reusable pen injector
PlaceboDrug
Abdominal s.c. self-administration with placebo when blood glucose levels are below 3.9 mmol/L or interstitial glucose levels below 3.5 mmol/L. The frequency of the intervention is approximately once a day.
| Study group | Role | What they receive |
|---|---|---|
| 120 µg dasiglucagon | Experimental | Subcutaneous 120 µg dasiglucagon self-administration Receives: Drug: Dasiglucagon; Device: HyoPen |
| Placebo | Placebo comparator | Subcutaneous placebo self-administration Receives: Device: HyoPen; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in hypoglycaemia (IG < 3.9 mmol)
The primary endpoint is the percentage of time in hypoglycaemia (IG <3.9 mmol/l) assessed by CGM during the out-patient part.
Measured: During the four weeks of placebo and dasiglucagon treatment.
Secondary outcomes (24)
Time (percent or minutes) spent in serious hypoglycaemia (IG <3.0 mmol/l)
Measured: During the four weeks of placebo and dasiglucagon treatment.
Frequency of hypoglycaemic events (IG <3.9 mmol/l and <3.0 mmol/l, respectively)
Measured: During the four weeks of placebo and dasiglucagon treatment.
Glycaemic time in range defined as: 1) hypoglycaemia (<3.9 mmol/l), 2) normoglycaemia (3.9-10.0 mmol/l), and 3) hyperglycaemia (>10.0 mmol/l)
Measured: During the four weeks of placebo and dasiglucagon treatment.
Frequency of hyperglycaemic events (IG >7.8 mmol/l and >10.0 mmol/l, respectively)
Measured: During the four weeks of placebo and dasiglucagon treatment.
Glycaemic variability assessed as coefficient of variance (CV)
Measured: During the four weeks of placebo and dasiglucagon treatment.
Glycaemic variability assessed as standard deviation (SD)
Measured: During the four weeks of placebo and dasiglucagon treatment.
Recovery of BG 15 minutes after trial drug administration (as measured by finger prick (BG >3.9 mmol/l))
Measured: During the four weeks of placebo and dasiglucagon treatment.
Change in QoL as assessed by the World Health Organization's quality of life assessment (WHOQOL-BREF)
likert scale, zero (very poor) to five (very good)
Measured: During the four weeks of placebo and dasiglucagon treatment.
Change in hypoglycaemic symptoms will be evaluated by Edinburgh Hypoglycaemia Symptom Scale (EHSS)
likert scale, zero (not a all) to seven (a lot)
Measured: During the four weeks of placebo and dasiglucagon treatment.
Change in fear of hypoglycaemia as assessed by Hypoglycaemia Fear Scale (HFS-II)
likert scale, zero (never) to four (always)
Measured: During the four weeks of placebo and dasiglucagon treatment.
Change in administration frequency (as measured by percentage)
Measured: During the four weeks of placebo and dasiglucagon treatment.
Nadir plasma glucose as assessed both as 1) absolute lowest value, and 2) a mean of three consecutive glucose measurements during the 240-minute MMT
Nadir plasma glucose after the postprandial peak during the MMT in the in-patient part
Measured: Two hundred forty minutes of mixed meal test
Recovery of BG 15 minutes after administration (as measured by finger prick (BG >3.9 mmol/l))
After the postprandial peak during the MMT in the in-patient part
Measured: Two hundred forty minutes of mixed meal test
Time spent in level 1 and level 2 hypoglycaemia (<3.9 and <3.0 mmol/l, respectively) from study drug administration until 240 minutes
After the postprandial peak during the MMT in the in-patient part
Measured: Two hundred forty minutes of mixed meal test
Glycaemic rescue intervention due to critically low plasma glucose concentration (<1.8 mmol/l)
During the MMT in the in-patient part
Measured: Two hundred forty minutes of mixed meal test
Time spent in hyperglycaemia (>7.8 mmol/l) from study drug administration until 240 minutes
During the MMT in the in-patient part
Measured: Two hundred forty minutes of mixed meal test
Peak plasma glucose concentration after study drug administration
During the MMT in the in-patient part
Measured: Two hundred forty minutes of mixed meal test
Counter-regulatory hormonal response
Measured as area under the curve (AUC) and / or incremental (iAUC) as appropriate, peak values and values at nadir plasma glucose concentration during the MMT in the in-patient part. glucagon-like peptide 1 (GLP-1), glucagon-like peptide 2 (GLP-2), glucose-dependent insulinotropic polypeptide (GIP)
Measured: Two hundred forty minutes of mixed meal test
Changes in blood pressure
During the MMT in the in-patient part
Measured: Two hundred forty minutes of mixed meal test
Changes in heart rate
During the MMT in the in-patient part
Measured: Two hundred forty minutes of mixed meal test
Frequency and severity of adverse events (AE)s and serious adverse events (SAE)s from signed consent form to end of study (visit 4 / follow-up visit)
Safety endpoint
Measured: Through study completion which is an average of 16 weeks
Frequency and severity of adverse events (AE)s and serious adverse events (SAE)s during the in-patient part MMTs
Safety endpoint
Measured: During the in-patient part (MMTs) 0-240 minutes / Two hundred forty minutes of mixed meal test
Percentage (%) of participants with treatment-induced or treatment-boosted anti-dasiglucagon antibodies who did not have anti-dasiglucagon antibodies at baseline
Safety endpoint
Measured: Through study completion which is an average of 16 weeks
Device failures/ malfunctions occurring during the trial.
Device endpoint
Measured: Through study completion which is an average of 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start20 Aug 2021
- Primary completion15 May 2022
- Study completion15 Dec 2022
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
- 4 weeks x 4 weeks with an interposed washout period of 1 week
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Filip Krag Knop
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand Pharma
- Responsible party
- Sponsor-investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
- Investigators
- Filip K Knop, MD, PhD, Principal investigator, Center for Clinical Metabolic Research at Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836273
- Sponsor's protocol ID
- CKN-DASI120-RYGB
- Other IDs
- 2020-005241-16
- Acronym
- SHERRY
- Status last verified
- Feb 2023
- First submitted
- 26 Mar 2021
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ready-to-use Dasiglucagon for the Treatment of Postprandial Hypoglycaemia in Roux-en-Y Gastric Bypass Operated Patients
- ClinicalTrials.gov ID
- NCT04836273
- Acronym / sponsor ID
- SHERRY / CKN-DASI120-RYGB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Filip Krag KnopUniversity, hospital or other
- Collaborators
- Zealand Pharma
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 8 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.
This is an investigator-initiated, proof-of-concept, randomised, double-blind, placebo-controlled, single-centre phase II study aiming to evaluate the efficacy, safety and tolerability of self-administered subcutaneous 120 µg dasiglucagon with an investigational trial device (i.e. a multi-dose reusable pen) for the treatment of postprandial hypoglycaemia after Roux-en-Y gastric bypass (RYGB) surgery. The study is divided into an in-patient and out-patient part.
The primary aim of the study is to compare the effects of self-administered 120 µg dasiglucagon versus placebo on continuous glucose monitoring (CGM)-assessed time spent in hypoglycaemia in RYGB-operated individuals in an out-patient setting.
Detailed description
Study design:
Before inclusion in the study, the participants will complete a screening visit and a blinded 14-day continuous glucose monitoring (CGM) run-in period to ascertain a regular occurrence of postprandial hypoglycaemia (IG <3.9 mmol/l, ≥3 times/week). After enrolment in the study, the participants will wear a CGM for the entirety of the study period (apart from the four weeks before the follow-up visit). Prior to the first mixed meal test (MMT) during the in-patient part, the subjects will be randomised into one of four double-blinded treatment sequences consisting of an in-patient part (two MMTs) follow by a nine weeks out-patient part (two times four weeks per out-patient part with an interposed washout period of one week) and ended with a follow-up visit four weeks after out-patient part completion.
During the in-patient part, the participants will undergo two separate MMTs, with a minimum of 7 days in-between, accompanied by one of the following double-blind, randomised, placebo-controlled crossover interventions:
- Subcutaneous placebo self-administration
- Subcutaneous 120 µg dasiglucagon self-administration
The out-patient part is divided into two double-blinded, randomised, placebo-controlled crossover out-patient parts with of the following interventions:
- Subcutaneous placebo self-administration
- Subcutaneous 120 µg dasiglucagon self-administration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 4 weeks x 4 weeks with an interposed washout period of 1 week
| Arm | Type | Receives |
|---|---|---|
| 120 µg dasiglucagon | Experimental | Drug: Dasiglucagon, Device: HyoPenSubcutaneous 120 µg dasiglucagon self-administration |
| Placebo | Placebo comparator | Device: HyoPen, Drug: PlaceboSubcutaneous placebo self-administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Documented postprandial hypoglycaemia (IG <3.9 mmol/l, ≥3 times/week) assessed by 14-days of blinded CGM recording
- Haemoglobin levels for women >7.3 mmol/l and for men >8.3 mmol/l
- Ferritin >10 μg/l
- Cobalamin >150 pmol/l
- Fasting plasma glucose concentration within the range of 4.0-6.0 mmol/l
Key exclusion criteria (13 listed)
- Treatment with medication(s) affecting insulin secretion, glucose metabolism or any antidiabetic drugs
- Treatment with antipsychotics
- Current participation in another clinical trial with administration of investigational drug
- Previous exposure to dasiglucagon (also known as ZP4207) within the last 30 days prior screening
- History of liver disease that is expected to interfere with the anti-hypoglycaemic action of glucagon (e.g. liver failure or cirrhosis)
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 |
|---|---|---|
| DasiglucagonAlso: ZP4207Abdominal s.c. self-administration 120 µg of dasiglucagon when blood glucose levels are below 3.9 mmol/L or interstitial glucose levels below 3.5 mmol/L. The frequency of the intervention is approximately once a day. | Drug | 120 µg dasiglucagon |
| HyoPenAlso: Zealand Penmulti-dose reusable pen injector | Device | 120 µg dasiglucagon, Placebo |
| PlaceboAbdominal s.c. self-administration with placebo when blood glucose levels are below 3.9 mmol/L or interstitial glucose levels below 3.5 mmol/L. The frequency of the intervention is approximately once a day. | Drug | Placebo |
Primary outcome
Time spent in hypoglycaemia (IG < 3.9 mmol)
Time frame: During the four weeks of placebo and dasiglucagon treatment.
The primary endpoint is the percentage of time in hypoglycaemia (IG <3.9 mmol/l) assessed by CGM during the out-patient part.
24 secondary outcomes
Time (percent or minutes) spent in serious hypoglycaemia (IG <3.0 mmol/l)
Time frame: During the four weeks of placebo and dasiglucagon treatment.
Frequency of hypoglycaemic events (IG <3.9 mmol/l and <3.0 mmol/l, respectively)
Time frame: During the four weeks of placebo and dasiglucagon treatment.
Glycaemic time in range defined as: 1) hypoglycaemia (<3.9 mmol/l), 2) normoglycaemia (3.9-10.0 mmol/l), and 3) hyperglycaemia (>10.0 mmol/l)
Time frame: During the four weeks of placebo and dasiglucagon treatment.
Frequency of hyperglycaemic events (IG >7.8 mmol/l and >10.0 mmol/l, respectively)
Time frame: During the four weeks of placebo and dasiglucagon treatment.
Glycaemic variability assessed as coefficient of variance (CV)
Time frame: During the four weeks of placebo and dasiglucagon treatment.
Glycaemic variability assessed as standard deviation (SD)
Time frame: During the four weeks of placebo and dasiglucagon treatment.
Recovery of BG 15 minutes after trial drug administration (as measured by finger prick (BG >3.9 mmol/l))
Time frame: During the four weeks of placebo and dasiglucagon treatment.
Change in QoL as assessed by the World Health Organization's quality of life assessment (WHOQOL-BREF)
Time frame: During the four weeks of placebo and dasiglucagon treatment.
Change in hypoglycaemic symptoms will be evaluated by Edinburgh Hypoglycaemia Symptom Scale (EHSS)
Time frame: During the four weeks of placebo and dasiglucagon treatment.
Change in fear of hypoglycaemia as assessed by Hypoglycaemia Fear Scale (HFS-II)
Time frame: During the four weeks of placebo and dasiglucagon treatment.
Change in administration frequency (as measured by percentage)
Time frame: During the four weeks of placebo and dasiglucagon treatment.
Nadir plasma glucose as assessed both as 1) absolute lowest value, and 2) a mean of three consecutive glucose measurements during the 240-minute MMT
Time frame: Two hundred forty minutes of mixed meal test
Recovery of BG 15 minutes after administration (as measured by finger prick (BG >3.9 mmol/l))
Time frame: Two hundred forty minutes of mixed meal test
Time spent in level 1 and level 2 hypoglycaemia (<3.9 and <3.0 mmol/l, respectively) from study drug administration until 240 minutes
Time frame: Two hundred forty minutes of mixed meal test
Glycaemic rescue intervention due to critically low plasma glucose concentration (<1.8 mmol/l)
Time frame: Two hundred forty minutes of mixed meal test
Time spent in hyperglycaemia (>7.8 mmol/l) from study drug administration until 240 minutes
Time frame: Two hundred forty minutes of mixed meal test
Peak plasma glucose concentration after study drug administration
Time frame: Two hundred forty minutes of mixed meal test
Counter-regulatory hormonal response
Time frame: Two hundred forty minutes of mixed meal test
Changes in blood pressure
Time frame: Two hundred forty minutes of mixed meal test
Changes in heart rate
Time frame: Two hundred forty minutes of mixed meal test
Frequency and severity of adverse events (AE)s and serious adverse events (SAE)s from signed consent form to end of study (visit 4 / follow-up visit)
Time frame: Through study completion which is an average of 16 weeks
Frequency and severity of adverse events (AE)s and serious adverse events (SAE)s during the in-patient part MMTs
Time frame: During the in-patient part (MMTs) 0-240 minutes / Two hundred forty minutes of mixed meal test
Percentage (%) of participants with treatment-induced or treatment-boosted anti-dasiglucagon antibodies who did not have anti-dasiglucagon antibodies at baseline
Time frame: Through study completion which is an average of 16 weeks
Device failures/ malfunctions occurring during the trial.
Time frame: Through study completion which is an average of 16 weeks
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 2 Feb 2023.
- 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.
Filip K Knop, MD, PhD principal investigator
Center for Clinical Metabolic Research at Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasiglucagon and HyoPen in people with Hyperinsulinemic Hypoglycemia and Postprandial Hypoglycemia, run by Filip Krag Knop at 1 site in Denmark.
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 7 inclusion and 13 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 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Time spent in hypoglycaemia (IG < 3.9 mmol) (time frame: During the four weeks of placebo and dasiglucagon treatment.). 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 2 Feb 2023.