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dasiglucagon

CompletedPhase 2Results posted

Feasibility Trial Testing the Bionic Pancreas With ZP4207

The Bionic Pancreas Feasibility Trial Testing the Bionic Pancreas With ZP4207

Lead sponsor

Zealand Pharma

Asset

Dasiglucagon

Subcutaneous · Glucagon receptor agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

13

Study population

Type 1 diabetes

Eligibility highlights

-

Primary endpoint

•Safety and Tolerability

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02971228
Org study IDZP4207-16051

Timeline

Milestones

Study first posted2016-11-22estimated
Primary completion2017-05-24actual
Study completion2017-06-07actual
Results first posted2021-02-08actual
Last update posted2021-03-23actual
Study start2016-11 (month precision)

Assets

Investigational agents

Dasiglucagon

Who this study enrolls

Type 1 diabetes

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Patients with T1DM for at least 1 year, as defined by the American Diabetes Association

2. Age ≥ 18 years

3. Prescription medication regimen stable for >1 month (except for medications not expected to affect trial safety or outcome, in the judgment of the investigator)

4. Diabetes managed using an insulin pump for >=6 months

5. Patients in good health according to age (medical history, physical examination, vital signs, 12-lead electrocardiograms [ECGs], laboratory assessments), as judged by the Investigator

Exclusion criteria

1. Previous exposure to ZP4207 or adverse reaction to glucagon

2. History of liver disease or current abnormal liver function tests (LFTs)

3. Renal failure

4. Anemia

5. History of coronary artery disease or congestive heart failure (class III or IV)

6. History of transient ischemic attack or stroke

7. Seizure disorder

8. Cystic fibrosis, pancreatitis, or any other pancreatic disease besides T1DM

9. Other endocrine disorders

10. Use of oral anti-diabetic medications

11. Electronically powered implants

12. Hypertension (≥160/100 mm Hg despite treatment)

13. Inadequate venous (vein) access as determined by trial nurse or physician at time of screening

Endpoints (38)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
20
Other (unclassified)
12
Safety / tolerability / PK
6

Glycemic / diabetes

20 endpoints
Secondary/protocol endpoint

Glycemic Regulation

Time frame:16 hours

descriptive

Secondary/registry result

Glycemic Regulation

Time frame:16 hours

descriptive

Posted result

GroupMean · percentage of time points95% CI
Part 1, ZP420712.78-
Part 1, Lilly Glucagon17.60-
Mean difference (final values)-6.9095% CI-19.63 - 5.84p0.2518t-test, 2 sided
Median difference (final values)-8.0295% CI-25.85 - 10.68p0.2500Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.

Time frame:16 hours

descriptive

Secondary/registry result

Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.

Time frame:16 hours

descriptive

Posted result

GroupMean · Percentage of treatment delivered95% CI
Part 1, ZP420798.36-
Part 1, Lilly Glucagon97.73-
Mean difference (final values)0.6395% CI-0.36 - 1.62p0.1847t-test, 2 sided
Median difference (final values)0.0295% CI-0.01 - 3.09p0.0781Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint

Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time Continuous Glucose Monitoring (CGM) Data

Time frame:16 hours

descriptive

Secondary/registry result

Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time Continuous Glucose Monitoring (CGM) Data

Time frame:16 hours

descriptive

Posted result

GroupMean · percentage of time functioning nominally95% CI
Part 1, ZP420795.41-
Part 1, Lilly Glucagon94.26-
Secondary/protocol endpoint

Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured

Time frame:16 hours

descriptive

Secondary/registry result

Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured

Time frame:16 hours

descriptive

Posted result

GroupMean · percentage of time functioning nominally95% CI
Part 1, ZP420797.86-
Part 1, Lilly Glucagon96.31-
Secondary/protocol endpoint

CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download

Time frame:16 hours

descriptive

Secondary/registry result

CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download

Time frame:16 hours

descriptive

Posted result

GroupMean · mg/dL95% CI
Part 1, ZP420712.6-
Part 1, Lilly Glucagon12.7-
Secondary/protocol endpoint

Diabetes Treatment Satisfaction Questionnaire - Status

Time frame:Up to 3 months

categorical status, descriptive

Secondary/registry result

Diabetes Treatment Satisfaction Questionnaire - Status

Time frame:Up to 3 months

categorical status, descriptive

Secondary/protocol endpoint

Diabetes Treatment Satisfaction Questionnaire - Change

Time frame:Up to 3 months

descriptive

Secondary/registry result

Diabetes Treatment Satisfaction Questionnaire - Change

Time frame:Up to 3 months

descriptive

Secondary/protocol endpoint

T1-Diabetes Distress Scale

Time frame:Up to 3 months

descriptive

Secondary/registry result

T1-Diabetes Distress Scale

Time frame:Up to 3 months

descriptive

Secondary/protocol endpoint

Problem Areas in Diabetes Survey

Time frame:Up to 3 months

descriptive

Secondary/registry result

Problem Areas in Diabetes Survey

Time frame:Up to 3 months

descriptive

Secondary/protocol endpoint

Impact of Daily Diabetes Demands

Time frame:Up to 3 months

descriptive

Secondary/registry result

Impact of Daily Diabetes Demands

Time frame:Up to 3 months

descriptive

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters

Time frame:Up to 50 days

descriptive

Primary/registry result

Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters

Time frame:Up to 50 days

descriptive

Posted result

GroupParticipants95% CI
Part 1, ZP4207Participants with AEs8-
Participants with antibodies0-
Participants with edema infusion site reactions0-
Participants with erythema infusion site reactions0-
Participants with investigations AEs2-
Participants with erythrocytes <LLN0-
Participants with hematocrit <LLN0-
Participants with hemoglobin <LLN0-
Participants with lymphocytes <LLN0-
Participants with infusion site pain (VAS)0-
Participants with nausea (VAS)4-
Participants with vascular disorders1-
Part 1, Lilly GlucagonParticipants with AEs12-
Participants with antibodies0-
Participants with edema infusion site reactions0-
Participants with erythema infusion site reactions0-
Participants with investigations AEs2-
Participants with erythrocytes <LLN1-
Participants with hematocrit <LLN1-
Participants with hemoglobin <LLN2-
Participants with lymphocytes <LLN1-
Participants with infusion site pain (VAS)2-
Participants with nausea (VAS)2-
Participants with vascular disorders1-
Secondary/protocol endpoint

Nausea Measured on a Visual Analog Scale (VAS)

Time frame:16 hours

descriptive

Secondary/registry result

Nausea Measured on a Visual Analog Scale (VAS)

Time frame:16 hours

descriptive

Posted result

GroupMean · cm95% CI
Part 1, ZP4207Baseline0.00-
Hour 10.12-
Hour 20.00-
Hour 30.11-
Hour 40.00-
Hour 50.02-
Hour 60.29-
Hour 70.00-
Visit end (16 hours)0.11-
Part 1, Lilly GlucagonBaseline0.00-
Hour 10.00-
Hour 20.00-
Hour 30.04-
Hour 40.00-
Hour 50.09-
Hour 60.18-
Hour 70.00-
Visit end (16 hours)0.00-
Secondary/protocol endpoint

Hypoglycemia Fear Survey

Time frame:Up to 3 months

descriptive

Secondary/registry result

Hypoglycemia Fear Survey

Time frame:Up to 3 months

descriptive

Other (unclassified)

12 endpoints
Secondary/protocol endpoint/low confidence

Pain Measured on a Visual Analog Scale (VAS)

Time frame:16 hours

descriptive

Secondary/registry result/low confidence

Pain Measured on a Visual Analog Scale (VAS)

Time frame:16 hours

descriptive

Posted result

GroupMean · cm95% CI
Part 1, ZP4207Baseline0.00-
Hour 10.00-
Hour 20.00-
Hour 30.00-
Hour 40.00-
Hour 50.00-
Hour 60.00-
Hour 70.00-
Visit end (16 hours)0.00-
Part 1, Lilly GlucagonBaseline0.01-
Hour 10.00-
Hour 20.00-
Hour 30.06-
Hour 40.00-
Hour 50.00-
Hour 60.00-
Hour 70.02-
Visit end (16 hours)0.00-
Secondary/protocol endpoint/low confidence

Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.

Time frame:16 hours

descriptive

Secondary/registry result/low confidence

Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.

Time frame:16 hours

descriptive

Posted result

GroupMean · Percentage of treatment delivered95% CI
Part 1, ZP420796.73-
Part 1, Lilly Glucagon97.01-
Mean difference (final values)-0.2895% CI-3.55 - 2.99p0.8508t-test, 2 sided
Median difference (final values)0.0395% CI-4.12 - 3.13p>0.9999Wilcoxon (Mann-Whitney)
Secondary/protocol endpoint/low confidence

CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM

Time frame:16 hours

descriptive

Secondary/registry result/low confidence

CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM

Time frame:16 hours

descriptive

Posted result

GroupMean · percentage of recorded values95% CI
Part 1, ZP420797.55-
Part 1, Lilly Glucagon97.94-
Secondary/protocol endpoint/low confidence

Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Calibration Issues

Time frame:16 hours

event count, event

Secondary/registry result/low confidence

Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Calibration Issues

Time frame:16 hours

event count, event

Posted result

GroupParticipants95% CI
Part 1, ZP42079-
Part 1, Lilly Glucagon11-
Secondary/protocol endpoint/low confidence

Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Connectivity Issues

Time frame:16 hours

event count, event

Secondary/registry result/low confidence

Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Connectivity Issues

Time frame:16 hours

event count, event

Posted result

GroupParticipants95% CI
Part 1, ZP42073-
Part 1, Lilly Glucagon2-
Secondary/protocol endpoint/low confidence

Bionic Pancreas User Opinion Survey

Time frame:Up to 3 months

descriptive

Secondary/registry result/low confidence

Bionic Pancreas User Opinion Survey

Time frame:Up to 3 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.