Type 1 Diabetes Mellitus With HypoglycemiaEarly Phase 1NCT04712266
A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes
A Early Phase 1 study testing Glucagon and Insulin in people with Type 1 Diabetes Mellitus With Hypoglycemia, run by Abvance Therapeutics at 1 site in United States.
Trial summary
This is a single center, double-blind, randomized trial in subjects with type 1 diabetes mellitus applying an adaptive design approach. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 1 Diabetes Mellitus With Hypoglycemia
- What is being tested?
- Glucagon and Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 10 Jan 2021
- Phase
- Early Phase 1
- 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
- Male or female patients aged between 18 and 64 years (both inclusive)
- Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit
- Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded Trial to Investigate Glycemic Excursions Following an Oral Mixed Meal Challenge in Subjects With Type 1 Diabetes When Concomitantly Treated With Insulin Alone or Co-administered Insulin and Glucagon
This is a single center, double-blind, randomized trial in subjects with type 1 diabetes mellitus applying an adaptive design approach.
Read the detailed description
Subjects were be studied on two occasions, in randomized sequence, whereby glycemic excursions are assessed following an oral mixed meal challenge while treated with either insulin alone or co-administered insulin and glucagon.
- Being tested
- Glucagon, Insulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucagonDrug
Also called Glucagen Hypokit
calculated IV insulin:Glucagon molar ratio
InsulinDrug
Also called Human Insulin (Eli Lilly)
calculated IV Insulin dose infused at a constant rate
| Study group | Role | What they receive |
|---|---|---|
| Insulin IV | Active comparator | calculated insulin rate Receives: Drug: Insulin |
| Insulin and Glucagon IV | Experimental | calculated molar ratio insulin:glucagon Receives: Drug: Glucagon; Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypoglycemic excursions
< 50mg/dl
Measured: 180-360 minutes post meal
hyperglycemic excursions
>150mg/dl
Measured: 60-120 minutes post meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start15 Sep 2020
- Primary completion15 Dec 2020
- Study completion10 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes Mellitus With 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abvance Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- T1D Exchange, United States
- Responsible party
- Sponsor
- Investigators
- Bruce Bode, MD, Principal investigator, Atlanta Diabetes Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712266
- Sponsor's protocol ID
- ABV201
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded Trial to Investigate Glycemic Excursions Following an Oral Mixed Meal Challenge in Subjects With Type 1 Diabetes When Concomitantly Treated With Insulin Alone or Co-administered Insulin and Glucagon
- ClinicalTrials.gov ID
- NCT04712266
- Acronym / sponsor ID
- ABV201
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Abvance TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- T1D Exchange, United States
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 15 Jan 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 a single center, double-blind, randomized trial in subjects with type 1 diabetes mellitus applying an adaptive design approach.
Detailed description
Subjects were be studied on two occasions, in randomized sequence, whereby glycemic excursions are assessed following an oral mixed meal challenge while treated with either insulin alone or co-administered insulin and glucagon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin IV | Active comparator | Drug: Insulincalculated insulin rate |
| Insulin and Glucagon IV | Experimental | Drug: Glucagon, Drug: Insulincalculated molar ratio insulin:glucagon |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female patients aged between 18 and 64 years (both inclusive)
- Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit
- Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| GlucagonAlso: Glucagen Hypokitcalculated IV insulin:Glucagon molar ratio | Drug | Insulin and Glucagon IV |
| InsulinAlso: Human Insulin (Eli Lilly)calculated IV Insulin dose infused at a constant rate | Drug | Insulin IV, Insulin and Glucagon IV |
Primary outcome
hypoglycemic excursions
Time frame: 180-360 minutes post meal
< 50mg/dl
hyperglycemic excursions
Time frame: 60-120 minutes post meal
>150mg/dl
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 15 Jan 2021.
- 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.
Bruce Bode, MD principal investigator
Atlanta Diabetes Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Glucagon and Insulin in people with Type 1 Diabetes Mellitus With Hypoglycemia, run by Abvance Therapeutics at 1 site 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 3 inclusion and 1 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 15 Jan 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 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
hypoglycemic excursions (time frame: 180-360 minutes post meal). 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?
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 15 Jan 2021.