HypoglycemiaPhase 4ALCO1NCT02881060
The Late Effects of Ethanol Intake on the Glucose Response to Subcutaneous Glucagon in Type 1 Diabetes
A Phase 4 study testing Alcohol in people with Hypoglycemia and Diabetes Mellitus, Type 1, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Objective: Because many people with type 1 diabetes drink ethanol and because glucagon is used to treat mild hypoglycaemia, it is essential to determine whether ethanol will impair the effectiveness of glucagon to increase glucose, which may impair the effectiveness of the dual hormone treatment in preventing… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypoglycemia, Diabetes Mellitus, Type 1
- What is being tested?
- Alcohol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2016to 26 Jan 2017
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 70 years
- T1D ≥ 3 year
- BMI 20-28 kg/m2
- CSII ≥ 1 year
- Caucasian origin
- Hypoglycaemia awareness (assessed by Gold, Clarke and Pedersen-Bjergaard methods)
- Use of carbohydrate counting and the insulin pump bolus calculator for all meals
- Ethanol exposure once within 1 year consisting of at least 4 drinks (1 drink contains 12 gram ethanol) within four hours
Who cannot join
- Allergy or intolerance to lactose or Glucagen®(Novo Nordisk, Bagsværd, DK)
- Allergy for ethanol or any food ingredients that will be used in the study.
- Impaired renal function (eGFR < 60 ml/min/1.73m2)
- Liver disease with ALAT > 2.5 times the upper limit of the reference interval
- Gastropareses (beat-beat variation < 10 beats per min and/or orthostatic systolic blood pressure > 20 mmHg)
- Insomnia, sleep apnoea or any troubles with sleeping that according to the investigator's assessment makes the individual unsuitable for study participation.
Show all 19Show fewer
- Aldehyde dehydrogenase deficiency as determined by a screening questionnaire
- Unable to refrain from the consumption of ethanol at least 24 hours prior to study start
- History of drinking problems or alcoholism, regardless of whether active or in remission.
- Use of benzodiazepines or barbiturates or opiates or other central nervous system depressant drugs that could act synergistically with ethanol to lower the level of consciousness
- History of drug abuse
- Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject.
- 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
- Use of medications that are known to cause QT interval prolongation
- Presence of pheochromocytoma
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the individual unsuitable for study participation
- Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
- Females who have different basal insulin pattern depending on their menstrual cycle.
- Inability to understand the individual information and to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Objective: Because many people with type 1 diabetes drink ethanol and because glucagon is used to treat mild hypoglycaemia, it is essential to determine whether ethanol will impair the effectiveness of glucagon to increase glucose, which may impair the effectiveness of the dual hormone treatment in preventing hypoglycaemia.
The purpose of this study is to determine, whether ethanol influences the glucose response to subcutaneous glucagon during mild hypoglycaemia.
Read more
The investigators hypothesize that prior evening ethanol consumption does not reduce the effect of a glucagon bolus to raise plasma glucose compared with no prior ethanol consumption.
The study aims:
- To determine the late effects of ethanol on the efficacy of subcutaneous glucagon to restore plasma glucose after an episode of mild hypoglycemia.
- To determine the late effects of ethanol on the counter-regulatory hormones and hypoglycaemia awareness during mild hypoglycaemia
A double-blinded placebo-controlled study will be conducted. Participants will serve as their own controls. Eligible participants will after an informed consent complete two study visits, one with and one without ethanol consumption, in a random order. On each study visit, participants are induced a insulin induced hypoglycemia, seven-eight hours after a meal with or without ethanol. Once plasma glucose is below 3.9 mmol/l, a subcutaneous injection of 100 mcg glucagon is administered. Two hours later a second bolus is administered.
- Conditions
- Hypoglycemia, Diabetes Mellitus, Type 1
- Being tested
- Alcohol, Placebo
- Keywords
- Glucagon, Ethanol
- Medical subject headings
- Hypoglycemia, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholDietary supplement
Also called Cocktail
PlaceboDietary supplement
Also called Mocktail
| Study group | Role | What they receive |
|---|---|---|
| Ethanol | Active comparator | Drinking a cocktail of ethanol (0.8 g ethanol per kg body weight), diet lemonade and water of 1:1:1 (volume distribution). Receives: Dietary Supplement: Alcohol |
| Non-ethanol | Placebo comparator | Drinking a cocktail of diet lemonade and water of 1:2 (volume distribution). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in plasma glucose
The primary endpoint is difference in increase in plasma glucose value after the first injection of 100 µg s.c. glucagon on study nights with ethanol vs. study nights without ethanol consumption.
Measured: 0-120 min after the first glucagon injection
Secondary outcomes (58)
Peak plasma glucose
Maximal plasma glucose after the first and second glucagon injection
Measured: 0-240 min after the first glucagon injection
Increase in plasma glucose
Increase in plasma glucose caused by the second glucagon injection.
Measured: 0-120 min after the second glucagon injection
Total AUC(0-120)
Total area under the glucose curve from 0-120 minutes after each glucagon injection
Measured: 0-240 min after the first glucagon injection
PI-AUC(0-120)
positive incremental area under the glucose curve from 0-120 minutes after each glucagon injection
Measured: 0-240 min after the first glucagon injection
Tmax
Time-to-peak glucose value after each glucagon injection glucagon injection
Measured: 0-240 min after the first glucagon injection
Time above 4.0mM
Duration of glucose above 4.0 mmol/l after first and second glucagon injection
Measured: 0-240 min after the first glucagon injection
Time above baseline
Duration of glucose above baseline after first and second glucagon injection
Measured: 0-240 min after the first glucagon injection
Rescue rates
Numbers of first and second glucagon injections that raises PG > 4.9 mmol/l
Measured: 0-240 min after the first glucagon injection
Hyperglycemia rates
Number of first and second glucagon injections that raises PG > 7.1 mmol/l
Measured: 0-240 min after the first glucagon injection
Changes in plasma ketone bodies, measured as area under the curve
Measured: 0-240 min after the first glucagon injection
Changes in plasma ketone bodies, measured as incremental peak
Measured: 0-240 min after the first glucagon injection
Changes in plasma glucagon, measured as area under the curve
Measured: 0-240 min after the first glucagon injection
Changes in plasma glucagon, measured as incremental peak
Measured: 0-240 min after the first glucagon injection
Changes in insulin, measured as area under the curve
Measured: 0-240 min after the first glucagon injection
Changes in insulin, measured as incremental peak
Measured: 0-240 min after the first glucagon injection
Changes in growth hormones, measured as area under the curve
Measured: 0-240 min after the first glucagon injection
Changes in growth hormones, measured as incremental peak
Measured: 0-240 min after the first glucagon injection
Changes in serum corticole, measured as area under the curve
Measured: 0-240 min after the first glucagon injection
Changes in serum corticole, measured as incremental peak
Measured: 0-240 min after the first glucagon injection
Changes in plasma ethanol, measured as area under the curve
Measured: 0-240 min after the first glucagon injection
Changes in plasma ethanol, measured as incremental peak
Measured: 0-240 min after the first glucagon injection
Changes in free fatty acids, measured as area under the curve
Measured: 0-240 min after the first glucagon injection
Changes in free fatty acids, measured as incremental peak
Measured: 0-240 min after the first glucagon injection
Changes in triglycerides, measured as area under the curve
Measured: 0-240 min after the first glucagon injection
Changes in triglycerides, measured as incremental peak
Measured: 0-240 min after the first glucagon injection
Average in blood pressure
Measured: 0-240 min after the first glucagon injection
Average heart rate
Measured: 0-240 min after the first glucagon injection
Intensity of hypoglycemia
Average changes in Edinburgh Hypoglycaemia Scale over time during insulin and glucagon phase
Measured: 0-240 min after the first glucagon injection
Cognitive impairment
Average scores in cognitive test 30 min before each glucagon injection.
Measured: 0-240 min after the first glucagon injection
Side effects
Average visual analogue scale score from 0-180 min for nausea and headache after glucagon injection
Measured: 0-240 min after the first glucagon injection
Incidence of vomiting
Incidence of vomiting after 0-4 hours after each glucagon injection.
Measured: 0-240 min after the first glucagon injection
Meal induced glucose excursion
Total and incremental area under the glucose curve from 0-120 and 0-240 min after eating the mixed meal
Measured: 0-3 hours after meal
Meal induced hormonal changes
Total and incremental area under the glucose curve from 0-120 and 0-240 min after eating the mixed meal
Measured: 0-3 hours after meal
Nocturnal changes in plasma glucose
Area under the curve during sleep
Measured: 0-6 hours after start of sleep
Nocturnal changes in corticol
Area under the curve during sleep
Measured: 0-6 hours after start of sleep
Nocturnal changes in growth hormone
Area under the curve during sleep
Measured: 0-6 hours after start of sleep
Nocturnal changes in ketones
Area under the curve during sleep
Measured: 0-6 hours after start of sleep
Nocturnal changes in ethanol
Area under the curve during sleep
Measured: 0-6 hours after start of sleep
Nocturnal changes in glucagon
Area under the curve during sleep
Measured: 0-6 hours after start of sleep
Difference between the first second glucagon injection and between both study visits in peak change plasma glucose
Measured: 0-240 min after the first glucagon injection
Difference between glucagon injections on both study visits in positive incremental area under the glucose curve from 0-120 minutes
Measured: 0-240 min after the first glucagon injection
Difference between glucagon injections on both study visits in total area under the glucose curve from 0-120 minutes
Measured: 0-240 min after the first glucagon injection
Difference between glucagon injections on both study visits in time-to-peak glucose value
Measured: 0-240 min after the first glucagon injection
Difference between glucagon injections on both study visits in duration of glucose above 4.0 mmol/l after first and second glucagon injection
Measured: 0-240 min after the first glucagon injection
Difference between glucagon injections on both study visits in duration of glucose above baseline after first and second glucagon injection
Measured: 0-240 min after the first glucagon injection
Difference in glucose sensor data on study night with alcohol vs. study night without alcohol - Mean absolute relative difference (MARD) values of glucose sensors compared with YSI from 7 PM- 8 AM.
Intentions to treat analysis
Measured: 0-10 hours after meal
Difference in glucose sensor data on study night with alcohol vs. study night without alcohol - Precision absolute relative difference (PARD) 120 min before and 120 after each glucagon injection.
Intentions to treat analysis
Measured: 0-10 hours after meal
Difference in glucose sensor data on study night with alcohol vs. study night without alcohol - MARD values between glucose sensors 0-120 minutes after each glucagon injection.
Intentions to treat analysis
Measured: 0-10 hours after meal
Difference in glucose sensor data within 2 days after study night with alcohol vs. study night without alcohol - Time in range (glucose sensor value =4.0-10.0mmol/l)
Intentions to treat analysis
Measured: 0-2 days after the first glucagon injection
Difference in glucose sensor data within 2 days after study night with alcohol vs. study night without alcohol - Time in hypoglycaemia (glucose sensor value < 4.0 mmol/l)
Intentions to treat analysis
Measured: 0-2 days after the first glucagon injection
Difference in glucose sensor data within 2 days after study night with alcohol vs. study night without alcohol - Time in hyperglycaemia (glucose sensor value >10.0mmol/l)
Intentions to treat analysis
Measured: 0-2 days after the first glucagon injection
Difference in glucose sensor data within 2 days after study night with alcohol vs. study night without alcohol - Number of hypoglycaemia episodes (glucose sensor value < 4.0 mmol/l)
Intentions to treat analysis
Measured: 0-2 days after the first glucagon injection
Difference in glucose sensor data between the study period with and without alcohol - Clarke- Error Grid analysis for both sensors compared with YSI during study visit
Intentions to treat analysis
Measured: -2 to 4 days after study visits
Difference in glucose sensor data between the study period with and without alcohol - PARD values from day 1-7
Intentions to treat analysis
Measured: -2 to 4 days after study visits
Difference in glucose sensor data between the study period with and without alcohol - PARD values <4.0 mmol/L from day 1-7
Intentions to treat analysis
Measured: -2 to 4 days after study visits
Difference in glucose sensor data between the study period with and without alcohol - PARD values 4.0-10.0 mmol/L from day 1-7
Intentions to treat analysis
Measured: -2 to 4 days after study visits
Difference in glucose sensor data between the study period with and without alcohol PARD values >10.0 mmol/L from day 1-7
Intentions to treat analysis
Measured: -2 to 4 days after study visits
Difference in glucose sensor data between the study period with and without alcohol - Number of hypoglycaemia episodes (glucose sensor value < 4.0 mmol/l)
Intentions to treat analysis
Measured: -2 to 4 days after study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion26 Jan 2017
- Study completion26 Jan 2017
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Diabetes Academy, University of Copenhagen
- Responsible party
- Principal investigator, Ajenthen Ranjan, Hvidovre University Hospital
- Investigators
- Ajenthen Ranjan, MD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881060
- Sponsor's protocol ID
- H-16027080
- Acronym
- ALCO1
- Status last verified
- Jul 2017
- First submitted
- 11 Aug 2016
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Late Effects of Ethanol Intake on the Glucose Response to Subcutaneous Glucagon in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02881060
- Acronym / sponsor ID
- ALCO1 / H-16027080
- Conditions
- Hypoglycemia, Diabetes Mellitus, Type 1
- Keywords
- Glucagon, Ethanol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Danish Diabetes Academy, University of Copenhagen
- Study start
- Aug 2016
- Primary completion
- 26 Jan 2017 (actual)
- Study completion
- 26 Jan 2017 (actual)
- First posted
- 26 Aug 2016 (estimated)
- 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.
Objective: Because many people with type 1 diabetes drink ethanol and because glucagon is used to treat mild hypoglycaemia, it is essential to determine whether ethanol will impair the effectiveness of glucagon to increase glucose, which may impair the effectiveness of the dual hormone treatment in preventing hypoglycaemia.
The purpose of this study is to determine, whether ethanol influences the glucose response to subcutaneous glucagon during mild hypoglycaemia.
The investigators hypothesize that prior evening ethanol consumption does not reduce the effect of a glucagon bolus to raise plasma glucose compared with no prior ethanol consumption.
The study aims:
- To determine the late effects of ethanol on the efficacy of subcutaneous glucagon to restore plasma glucose after an episode of mild hypoglycemia.
- To determine the late effects of ethanol on the counter-regulatory hormones and hypoglycaemia awareness during mild hypoglycaemia
A double-blinded placebo-controlled study will be conducted. Participants will serve as their own controls. Eligible participants will after an informed consent complete two study visits, one with and one without ethanol consumption, in a random order. On each study visit, participants are induced a insulin induced hypoglycemia, seven-eight hours after a meal with or without ethanol. Once plasma glucose is below 3.9 mmol/l, a subcutaneous injection of 100 mcg glucagon is administered. Two hours later a second bolus is administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ethanol | Active comparator | Dietary Supplement: AlcoholDrinking a cocktail of ethanol (0.8 g ethanol per kg body weight), diet lemonade and water of 1:1:1 (volume distribution). |
| Non-ethanol | Placebo comparator | Dietary Supplement: PlaceboDrinking a cocktail of diet lemonade and water of 1:2 (volume distribution). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 - 70 years
- T1D ≥ 3 year
- BMI 20-28 kg/m2
- CSII ≥ 1 year
- Caucasian origin
Key exclusion criteria (19 listed)
- Allergy or intolerance to lactose or Glucagen®(Novo Nordisk, Bagsværd, DK)
- Allergy for ethanol or any food ingredients that will be used in the study.
- Impaired renal function (eGFR < 60 ml/min/1.73m2)
- Liver disease with ALAT > 2.5 times the upper limit of the reference interval
- Gastropareses (beat-beat variation < 10 beats per min and/or orthostatic systolic blood pressure > 20 mmHg)
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 |
|---|---|---|
| AlcoholAlso: Cocktail | Dietary supplement | Ethanol |
| PlaceboAlso: Mocktail | Dietary supplement | Non-ethanol |
Primary outcome
Increase in plasma glucose
Time frame: 0-120 min after the first glucagon injection
The primary endpoint is difference in increase in plasma glucose value after the first injection of 100 µg s.c. glucagon on study nights with ethanol vs. study nights without ethanol consumption.
58 secondary outcomes
Peak plasma glucose
Time frame: 0-240 min after the first glucagon injection
Increase in plasma glucose
Time frame: 0-120 min after the second glucagon injection
Total AUC(0-120)
Time frame: 0-240 min after the first glucagon injection
PI-AUC(0-120)
Time frame: 0-240 min after the first glucagon injection
Tmax
Time frame: 0-240 min after the first glucagon injection
Time above 4.0mM
Time frame: 0-240 min after the first glucagon injection
Time above baseline
Time frame: 0-240 min after the first glucagon injection
Rescue rates
Time frame: 0-240 min after the first glucagon injection
Hyperglycemia rates
Time frame: 0-240 min after the first glucagon injection
Changes in plasma ketone bodies, measured as area under the curve
Time frame: 0-240 min after the first glucagon injection
Changes in plasma ketone bodies, measured as incremental peak
Time frame: 0-240 min after the first glucagon injection
Changes in plasma glucagon, measured as area under the curve
Time frame: 0-240 min after the first glucagon injection
Changes in plasma glucagon, measured as incremental peak
Time frame: 0-240 min after the first glucagon injection
Changes in insulin, measured as area under the curve
Time frame: 0-240 min after the first glucagon injection
Changes in insulin, measured as incremental peak
Time frame: 0-240 min after the first glucagon injection
Changes in growth hormones, measured as area under the curve
Time frame: 0-240 min after the first glucagon injection
Changes in growth hormones, measured as incremental peak
Time frame: 0-240 min after the first glucagon injection
Changes in serum corticole, measured as area under the curve
Time frame: 0-240 min after the first glucagon injection
Changes in serum corticole, measured as incremental peak
Time frame: 0-240 min after the first glucagon injection
Changes in plasma ethanol, measured as area under the curve
Time frame: 0-240 min after the first glucagon injection
Changes in plasma ethanol, measured as incremental peak
Time frame: 0-240 min after the first glucagon injection
Changes in free fatty acids, measured as area under the curve
Time frame: 0-240 min after the first glucagon injection
Changes in free fatty acids, measured as incremental peak
Time frame: 0-240 min after the first glucagon injection
Changes in triglycerides, measured as area under the curve
Time frame: 0-240 min after the first glucagon injection
Changes in triglycerides, measured as incremental peak
Time frame: 0-240 min after the first glucagon injection
Average in blood pressure
Time frame: 0-240 min after the first glucagon injection
Average heart rate
Time frame: 0-240 min after the first glucagon injection
Intensity of hypoglycemia
Time frame: 0-240 min after the first glucagon injection
Cognitive impairment
Time frame: 0-240 min after the first glucagon injection
Side effects
Time frame: 0-240 min after the first glucagon injection
Incidence of vomiting
Time frame: 0-240 min after the first glucagon injection
Meal induced glucose excursion
Time frame: 0-3 hours after meal
Meal induced hormonal changes
Time frame: 0-3 hours after meal
Nocturnal changes in plasma glucose
Time frame: 0-6 hours after start of sleep
Nocturnal changes in corticol
Time frame: 0-6 hours after start of sleep
Nocturnal changes in growth hormone
Time frame: 0-6 hours after start of sleep
Nocturnal changes in ketones
Time frame: 0-6 hours after start of sleep
Nocturnal changes in ethanol
Time frame: 0-6 hours after start of sleep
Nocturnal changes in glucagon
Time frame: 0-6 hours after start of sleep
Difference between the first second glucagon injection and between both study visits in peak change plasma glucose
Time frame: 0-240 min after the first glucagon injection
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 24 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
Ajenthen Ranjan, MD principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alcohol in people with Hypoglycemia and Diabetes Mellitus, Type 1, run by Hvidovre University Hospital 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 8 inclusion and 19 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 24 Jul 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Increase in plasma glucose (time frame: 0-120 min after the first glucagon injection). 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 24 Jul 2017; AzTrials last refreshed its copy on 7 Nov 2026.