Type 1 DiabetesPhase 2NCT04449692
Low-dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes
A Phase 2 study testing Dasiglucagon and Carbohydrate (dextrose tablets) in people with Type 1 Diabetes and Hypoglycemia, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
The aim of the study is to compare the efficacy of low-dose dasiglucagon (Zealand Pharma, Denmark) to oral carbohydrate consumption for prevention of s.c. insulin-induced hypoglycemia in CSII- and MDI-treated people with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia
- What is being tested?
- Dasiglucagon and Carbohydrate (dextrose tablets)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Jul 2020to 4 Jan 2021
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-64 years
- Duration of T1D ≥ 3 years
- Use of CSII or MDI therapy for ≥ 6 months
- Current use of Novorapid (change from another fast-acting insulin to Novorapid prior to study initiation is allowed)
- HbA1c ≤ 8.0%
- Regular use of carbohydrate counting in the judgement of the investigator
Who cannot join
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
- History of allergy or intolerance to glucagon or glucagon-like products
- Patients with pheochromocytoma
- Clinically significant ECG abnormalities
- Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection)
- Inability to understand the individual information and to give informed consent
- Current participation in another clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject
- Other concomitant medical or psychological condition that, according to the investigator's assessment, makes the individual unsuitable for study participation
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to compare the efficacy of low-dose dasiglucagon (Zealand Pharma, Denmark) to oral carbohydrate consumption for prevention of s.c. insulin-induced hypoglycemia in CSII- and MDI-treated people with type 1 diabetes.
Read the detailed description
Near-normalization of blood glucose levels through intensive insulin therapy has shown to reduce the risk of diabetes late complications, but the approach is associated with two major side effects: hypoglycemia and weight gain. Although management of hypoglycemia through oral carbohydrate consumption is generally effective, the approach can lead to excessive carbohydrate intake and cause rebound hyperglycemia. It has previously been demonstrated that subcutaneous (s.c.) low-dose glucagon can be utilized to effectively treat mild hypoglycemia in people with type 1 diabetes. However, the instability in aqueous solution of currently available glucagon and the need for reconstitution with sterile water immediately prior to administration has limited its clinical role outside emergency settings. Due to the stability and ready-to-use formulation, dasiglucagon does not hold the limitations known for the currently available glucagon preparations.
The aim of this randomized, partially single-blinded, three-arm cross-over study is to compare the efficacy of low-dose dasiglucagon (80 and 120 μg) to oral carbohydrate (15 g) consumption for prevention of s.c. insulin-induced hypoglycemia in CSII- and MDI-treated people with type 1 diabetes. On each study visit (separated by ≥ 3 days), an initial insulin bolus will be administered (at t = 0) aiming for a plasma glucose (PG) level of 3.0 mmol/l. When reaching 4.5 mmol/l, the intervention (s.c. dasiglucagon or oral carbohydrates) will be administered (t-intervention = 0), whereafter PG will me monitored for an additional 180 min.
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Being tested
- Dasiglucagon, Carbohydrate (dextrose tablets)
- Keywords
- Type 1 Diabetes, Hypoglycemia, Dasiglucagon
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasiglucagonDrug
Abdominal s.c. administration
Carbohydrate (dextrose tablets)Other
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| 80 µg s.c. dasiglucagon | Experimental | 80 µg of dasiglucagon will be administered subcutaneously when plasma glucose levels reach 4.5 mmol/l Receives: Drug: Dasiglucagon |
| 120 µg s.c. dasiglucagon | Experimental | 120 µg of dasiglucagon will be administered subcutaneously when plasma glucose levels reach 4.5 mmol/l Receives: Drug: Dasiglucagon |
| 15 g oral carbohydrate (dextrose tablets) | Active comparator | 15 g of oral carbohydrate (dextrose tablets) will be administered when plasma glucose levels reach 4.5 mmol/l Receives: Other: Carbohydrate (dextrose tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between study visits in time (min) in hypoglycemia (plasma glucose < 3.9 mmol/l) from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Secondary outcomes (24)
Difference between study visits in incidence rate of hypoglycemia (plasma glucose < 3.9 mmol/l) from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in incidence rate of level 2 hypoglycemia (plasma glucose < 3.0 mmol/l) from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in incidence rate of rebound hyperglycemia (plasma glucose > 10 mmol/l) from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in nadir plasma glucose concentration from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in peak plasma glucose concentration from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in incremental peak in plasma glucose concentration from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in mean plasma glucose concentration from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in time (min) from intervention to first increase in plasma glucose concentration of 1.1 mmol/l
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in plasma glucose Area Under the Curve (AUC) from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in time (min) to peak plasma glucose concentration from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in time (min) in range (plasma glucose ≥ 3.9 mmol/l and 10.0 mmol/l) from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in time (min) in hyperglycemia (plasma glucose > 10 mmol/l) from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in time (%) in hypoglycemia (plasma glucose < 3.9 mmol/l) (per protocol) from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in incidence rate of rescue carbohydrate administration from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in time (min) to rescue carbohydrate administration from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in plasma dasiglucagon Area Under the Curve (AUC) from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in peak plasma dasiglucagon concentration from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in time to peak plasma dasiglucagon concentration from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in serum insulin concentration at visit start (t = 0) and immediately before administration of the intervention (t-intervention = 0)
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in serum insulin AUC from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in dose (units) of insulin bolus at study start (t = 0)
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in change in Edinburgh Hypoglycemia Symptoms Scale (EHSS) from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in change in visual analogue scale (VAS) for nausea, headache, stomach ache, injection site pain, palpitations and hunger from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in incidence rate of vomiting from 0-180 minutes post-intervention
Measured: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start2 Jul 2020
- Primary completion4 Jan 2021
- Study completion4 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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
- Single-blinded, randomized (using blocks of 3/6 and stratification by treatment modality), three-arm crossover study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Laugesen, MD, Principal investigator, MD, PhD Candidate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449692
- Sponsor's protocol ID
- H-20013256
- Other IDs
- 2020-000551-12, H-20013256
- Status last verified
- Feb 2021
- First submitted
- 24 Jun 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laugesen C, Ranjan AG, Schmidt S, Norgaard K. Low-Dose Dasiglucagon Versus Oral Glucose for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes: A Phase 2, Randomized, Three-Arm Crossover Study. Diabetes Care. 2022 Jun 2;45(6):1391-1399. doi: 10.2337/dc21-2304.
PubMed 35475907
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04449692
- Acronym / sponsor ID
- H-20013256
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Keywords
- Type 1 Diabetes, Hypoglycemia, Dasiglucagon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 4 Jan 2021 (actual)
- Study completion
- 4 Jan 2021 (actual)
- First posted
- 29 Jun 2020 (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 aim of the study is to compare the efficacy of low-dose dasiglucagon (Zealand Pharma, Denmark) to oral carbohydrate consumption for prevention of s.c. insulin-induced hypoglycemia in CSII- and MDI-treated people with type 1 diabetes.
Detailed description
Near-normalization of blood glucose levels through intensive insulin therapy has shown to reduce the risk of diabetes late complications, but the approach is associated with two major side effects: hypoglycemia and weight gain. Although management of hypoglycemia through oral carbohydrate consumption is generally effective, the approach can lead to excessive carbohydrate intake and cause rebound hyperglycemia. It has previously been demonstrated that subcutaneous (s.c.) low-dose glucagon can be utilized to effectively treat mild hypoglycemia in people with type 1 diabetes. However, the instability in aqueous solution of currently available glucagon and the need for reconstitution with sterile water immediately prior to administration has limited its clinical role outside emergency settings. Due to the stability and ready-to-use formulation, dasiglucagon does not hold the limitations known for the currently available glucagon preparations.
The aim of this randomized, partially single-blinded, three-arm cross-over study is to compare the efficacy of low-dose dasiglucagon (80 and 120 μg) to oral carbohydrate (15 g) consumption for prevention of s.c. insulin-induced hypoglycemia in CSII- and MDI-treated people with type 1 diabetes. On each study visit (separated by ≥ 3 days), an initial insulin bolus will be administered (at t = 0) aiming for a plasma glucose (PG) level of 3.0 mmol/l. When reaching 4.5 mmol/l, the intervention (s.c. dasiglucagon or oral carbohydrates) will be administered (t-intervention = 0), whereafter PG will me monitored for an additional 180 min.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Single-blinded, randomized (using blocks of 3/6 and stratification by treatment modality), three-arm crossover study
| Arm | Type | Receives |
|---|---|---|
| 80 µg s.c. dasiglucagon | Experimental | Drug: Dasiglucagon80 µg of dasiglucagon will be administered subcutaneously when plasma glucose levels reach 4.5 mmol/l |
| 120 µg s.c. dasiglucagon | Experimental | Drug: Dasiglucagon120 µg of dasiglucagon will be administered subcutaneously when plasma glucose levels reach 4.5 mmol/l |
| 15 g oral carbohydrate (dextrose tablets) | Active comparator | Other: Carbohydrate (dextrose tablets)15 g of oral carbohydrate (dextrose tablets) will be administered when plasma glucose levels reach 4.5 mmol/l |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-64 years
- Duration of T1D ≥ 3 years
- Use of CSII or MDI therapy for ≥ 6 months
- Current use of Novorapid (change from another fast-acting insulin to Novorapid prior to study initiation is allowed)
- HbA1c ≤ 8.0%
Key exclusion criteria (8 listed)
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
- History of allergy or intolerance to glucagon or glucagon-like products
- Patients with pheochromocytoma
- Clinically significant ECG abnormalities
- Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection)
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 |
|---|---|---|
| DasiglucagonAbdominal s.c. administration | Drug | 120 µg s.c. dasiglucagon, 80 µg s.c. dasiglucagon |
| Carbohydrate (dextrose tablets)Oral administration | Other | 15 g oral carbohydrate (dextrose tablets) |
Primary outcome
Difference between study visits in time (min) in hypoglycemia (plasma glucose < 3.9 mmol/l) from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
24 secondary outcomes
Difference between study visits in incidence rate of hypoglycemia (plasma glucose < 3.9 mmol/l) from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in incidence rate of level 2 hypoglycemia (plasma glucose < 3.0 mmol/l) from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in incidence rate of rebound hyperglycemia (plasma glucose > 10 mmol/l) from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in nadir plasma glucose concentration from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in peak plasma glucose concentration from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in incremental peak in plasma glucose concentration from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in mean plasma glucose concentration from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in time (min) from intervention to first increase in plasma glucose concentration of 1.1 mmol/l
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in plasma glucose Area Under the Curve (AUC) from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in time (min) to peak plasma glucose concentration from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in time (min) in range (plasma glucose ≥ 3.9 mmol/l and 10.0 mmol/l) from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in time (min) in hyperglycemia (plasma glucose > 10 mmol/l) from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in time (%) in hypoglycemia (plasma glucose < 3.9 mmol/l) (per protocol) from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in incidence rate of rescue carbohydrate administration from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in time (min) to rescue carbohydrate administration from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in plasma dasiglucagon Area Under the Curve (AUC) from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in peak plasma dasiglucagon concentration from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in time to peak plasma dasiglucagon concentration from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in serum insulin concentration at visit start (t = 0) and immediately before administration of the intervention (t-intervention = 0)
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in serum insulin AUC from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in dose (units) of insulin bolus at study start (t = 0)
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in change in Edinburgh Hypoglycemia Symptoms Scale (EHSS) from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in change in visual analogue scale (VAS) for nausea, headache, stomach ache, injection site pain, palpitations and hunger from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Difference between study visits in incidence rate of vomiting from 0-180 minutes post-intervention
Time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
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 9 Feb 2021.
- Derived from this study: PubMed 35475907Laugesen C, Ranjan AG, Schmidt S, Norgaard K. Low-Dose Dasiglucagon Versus Oral Glucose for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes: A Phase 2, Randomized, Three-Arm Crossover Study. Diabetes Care. 2022 Jun 2;45(6):1391-1399. doi: 10.2337/dc21-2304.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Christian Laugesen, MD principal investigator
MD, PhD Candidate
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 Carbohydrate (dextrose tablets) in people with Type 1 Diabetes and Hypoglycemia, run by Steno Diabetes Center Copenhagen 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 6 inclusion and 8 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 9 Feb 2021. 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. 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?
Difference between study visits in time (min) in hypoglycemia (plasma glucose < 3.9 mmol/l) from 0-180 minutes post-intervention (time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)). 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 NCT04449692, which also lists 1 linked publication.
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 9 Feb 2021.