Type 1 DiabetesPhase 2NCT01828125
Efficacy of Small Subcutaneous Glucagon Dose to Treat Hypoglycemia in Adults With Type 1 Diabetes
A Phase 2 study testing Hypoglycaemic hyperinsulinemic clamp and Glucagon in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial summary
In the unfortunate case of severe hypoglycaemia, glucagon is the first-line treatment because of its potent and rapid action starting as fast as 5 minutes after subcutaneous or intramuscular injection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Hypoglycaemic hyperinsulinemic clamp and Glucagon
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years of old
- Clinical diagnosis of type 1 diabetes for at least two years.
Who cannot join
- Clinically significant nephropathy (MDRD < 60 mL/min/1.73 m2).
- Pregnancy
- Severe hypoglycemic episode within two weeks of screening
- Current use of glucocorticoid medication (except low stable dose)
- Pheochromocytoma or primary adrenal insufficiency (e.g. Addison's disease)
- Medical condition likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
About this study
Official title: A Double-blinded, Randomized, Two-way, Cross-over Study to Assess the Efficacy of Small Subcutaneous Glucagon Dose Against the Conventional 1 mg Dose to Treat Hypoglycemia in Adults With Type 1 Diabetes
In the unfortunate case of severe hypoglycaemia, glucagon is the first-line treatment because of its potent and rapid action starting as fast as 5 minutes after subcutaneous or intramuscular injection. Large dose of glucagon such as 1 mg subcutaneous is usually associated with undesirable side-effects such as nausea, vomiting, bloating and headache.
The overall objective of this research proposal is to assess the efficacy of lower subcutaneous doses of glucagon (0.1 mg or 0.2 mg) to correct hypoglycaemia compared to the standard dose (1.0 mg) in adults with type 1 diabetes mellitus (T1D).
It is postulated that much lower dosages of glucagon (0.1 or 0.2 mg) injected subcutaneously will be just as effective as the current recommended dose of 1.0 mg to correct hypoglycaemia without the undesirable gastro-intestinal side effects.
Read the detailed description
In the unfortunate case of severe hypoglycaemia, glucagon is the first-line treatment because of its potent and rapid action starting as fast as 5 minutes after subcutaneous or intramuscular injection. Current instructions for the treatment of severe hypoglycaemia call for the immediate injection of 1 mg of glucagon subcutaneously or intramuscularly. Large dose of glucagon such as 1 mg subcutaneous is usually associated with undesirable side-effects such as nausea, vomiting, bloating and headache. Moreover, glucagon emergency kits are relatively expensive (around $100 per kit), thus increasing the financial burden of diabetes on patients and the health care system.
The primary objective of this research project is to the study the pharmacological effects of different doses of glucagon injected subcutaneously to correct hypoglycaemia during controlled conditions mimicking a hypoglycaemic event in adults with type 1 diabetes. More specifically, we will be looking at the effects of subcutaneous glucagon injected at 0.1 or 0.2 mg and 1.0 mg to normalized plasma glucose during a hypoglycaemic hyperinsulinemic clamp in subjects with type 1 diabetes.
- Conditions
- Type 1 Diabetes
- Being tested
- Hypoglycaemic hyperinsulinemic clamp, Glucagon
- Keywords
- Type 1 diabetes, Hypoglycemia, Glucagon, Hypoglycaemic hyperinsulinemic clamp
- 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.
Hypoglycaemic hyperinsulinemic clampProcedure or surgery
A first catheter will be inserted for infusion of D-[6,6-2H2] glucose and insulin. A second catheter will be inserted for infusion of dextrose. Dextrose infusion will be enriched with D-[6,6-2H2] glucose. A third catheter will be inserted for sampling. D-[6,6-2H2] glucose will be administered as a priming dose followed by a constant infusion throughout the experiment. Insulin will be administered as a primed continuous infusion. The first two hours will serve as an equilibration period for the tracer while glucose infusion will be adjusted to achieve a plasma glucose concentration of 5 mmol/L. The third hour is considered the baseline period. Following this, dextrose infusion rate will be decreased over a period of 1 hour to attain hypoglycaemia with a target blood glucose level at 2.8 mmol/L. At the end of the fourth hour, a subcutaneous glucagon dose will be given and plasma samples will be drawn for the determination of labelled and unlabelled glucose, plasma insulin and glucagon.
GlucagonDrug
| Study group | Role | What they receive |
|---|---|---|
| Hyperinsulinemic hypoglycaemic clamp 1mg glucagon | Active comparator | A 1.0mg glucagon dose will be given during the hyperinsulinemic hypoglycaemic clamp Receives: Procedure: Hypoglycaemic hyperinsulinemic clamp; Drug: Glucagon |
| Hyperinsulinemic hypoglycaemic clamp 0.1 or 0.2mg glucagon | Active comparator | A dose of 0.1mg or 0.2mg will be given during the hyperinsulinemic hypoglycaemic clamp. Receives: Procedure: Hypoglycaemic hyperinsulinemic clamp; Drug: Glucagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental area under the curve of plasma glucose concentrations
30-min incremental area under the curve of plasma glucose concentrations starting at the time glucagon is injected subcutaneously
Measured: 30 minutes
Secondary outcomes (6)
Time to reach glucose levels ≥ 4 mmol/L
Measured: Up to 2.5 hours
Time to reach glucose levels ≥ 5 mmol/L
Measured: Up to 2.5 hours
Time-to-peak plasma glucagon concentration
Time-to-peak plasma glucagon concentration after glucagon injection
Measured: Up to 2.5 hours
Time for 25% of glucagon appearance
Time for 25% of glucagon appearance after glucagon injection
Measured: Up to 2.5 hours
Time for 50% of glucagon appearance
Time for 50% of glucagon appearance after glucagon injection
Measured: Up to 2.5 hours
Time for 75% of glucagon appearance
Time for 75% of glucagon appearance after glucagon injection
Measured: Up to 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
- Investigators
- Rémi Rabasa-Lhoret, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828125
- Sponsor's protocol ID
- Mini-doses glucagon
- Status last verified
- Dec 2013
- First submitted
- 2 Apr 2013
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Randomized, Two-way, Cross-over Study to Assess the Efficacy of Small Subcutaneous Glucagon Dose Against the Conventional 1 mg Dose to Treat Hypoglycemia in Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01828125
- Acronym / sponsor ID
- Mini-doses glucagon
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Hypoglycemia, Glucagon, Hypoglycaemic hyperinsulinemic clamp
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 10 Apr 2013 (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.
In the unfortunate case of severe hypoglycaemia, glucagon is the first-line treatment because of its potent and rapid action starting as fast as 5 minutes after subcutaneous or intramuscular injection. Large dose of glucagon such as 1 mg subcutaneous is usually associated with undesirable side-effects such as nausea, vomiting, bloating and headache.
The overall objective of this research proposal is to assess the efficacy of lower subcutaneous doses of glucagon (0.1 mg or 0.2 mg) to correct hypoglycaemia compared to the standard dose (1.0 mg) in adults with type 1 diabetes mellitus (T1D).
It is postulated that much lower dosages of glucagon (0.1 or 0.2 mg) injected subcutaneously will be just as effective as the current recommended dose of 1.0 mg to correct hypoglycaemia without the undesirable gastro-intestinal side effects.
Detailed description
In the unfortunate case of severe hypoglycaemia, glucagon is the first-line treatment because of its potent and rapid action starting as fast as 5 minutes after subcutaneous or intramuscular injection. Current instructions for the treatment of severe hypoglycaemia call for the immediate injection of 1 mg of glucagon subcutaneously or intramuscularly. Large dose of glucagon such as 1 mg subcutaneous is usually associated with undesirable side-effects such as nausea, vomiting, bloating and headache. Moreover, glucagon emergency kits are relatively expensive (around $100 per kit), thus increasing the financial burden of diabetes on patients and the health care system.
The primary objective of this research project is to the study the pharmacological effects of different doses of glucagon injected subcutaneously to correct hypoglycaemia during controlled conditions mimicking a hypoglycaemic event in adults with type 1 diabetes. More specifically, we will be looking at the effects of subcutaneous glucagon injected at 0.1 or 0.2 mg and 1.0 mg to normalized plasma glucose during a hypoglycaemic hyperinsulinemic clamp in subjects with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperinsulinemic hypoglycaemic clamp 1mg glucagon | Active comparator | Procedure: Hypoglycaemic hyperinsulinemic clamp, Drug: GlucagonA 1.0mg glucagon dose will be given during the hyperinsulinemic hypoglycaemic clamp |
| Hyperinsulinemic hypoglycaemic clamp 0.1 or 0.2mg glucagon | Active comparator | Procedure: Hypoglycaemic hyperinsulinemic clamp, Drug: GlucagonA dose of 0.1mg or 0.2mg will be given during the hyperinsulinemic hypoglycaemic clamp. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females ≥ 18 years of old
- Clinical diagnosis of type 1 diabetes for at least two years.
Key exclusion criteria (6 listed)
- Clinically significant nephropathy (MDRD < 60 mL/min/1.73 m2).
- Pregnancy
- Severe hypoglycemic episode within two weeks of screening
- Current use of glucocorticoid medication (except low stable dose)
- Pheochromocytoma or primary adrenal insufficiency (e.g. Addison's disease)
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 |
|---|---|---|
| Hypoglycaemic hyperinsulinemic clampA first catheter will be inserted for infusion of D-[6,6-2H2] glucose and insulin. A second catheter will be inserted for infusion of dextrose. Dextrose infusion will be enriched with D-[6,6-2H2] glucose. A third catheter will be inserted for sampling. D-[6,6-2H2] glucose will be administered as a priming dose followed by a constant infusion throughout the experiment. Insulin will be administered as a primed continuous infusion. The first two hours will serve as an equilibration period for the tracer while glucose infusion will be adjusted to achieve a plasma glucose concentration of 5 mmol/L. The third hour is considered the baseline period. Following this, dextrose infusion rate will be decreased over a period of 1 hour to attain hypoglycaemia with a target blood glucose level at 2.8 mmol/L. At the end of the fourth hour, a subcutaneous glucagon dose will be given and plasma samples will be drawn for the determination of labelled and unlabelled glucose, plasma insulin and glucagon. | Procedure or surgery | Hyperinsulinemic hypoglycaemic clamp 0.1 or 0.2mg glucagon, Hyperinsulinemic hypoglycaemic clamp 1mg glucagon |
| Glucagon | Drug | Hyperinsulinemic hypoglycaemic clamp 0.1 or 0.2mg glucagon, Hyperinsulinemic hypoglycaemic clamp 1mg glucagon |
Primary outcome
Incremental area under the curve of plasma glucose concentrations
Time frame: 30 minutes
30-min incremental area under the curve of plasma glucose concentrations starting at the time glucagon is injected subcutaneously
6 secondary outcomes
Time to reach glucose levels ≥ 4 mmol/L
Time frame: Up to 2.5 hours
Time to reach glucose levels ≥ 5 mmol/L
Time frame: Up to 2.5 hours
Time-to-peak plasma glucagon concentration
Time frame: Up to 2.5 hours
Time for 25% of glucagon appearance
Time frame: Up to 2.5 hours
Time for 50% of glucagon appearance
Time frame: Up to 2.5 hours
Time for 75% of glucagon appearance
Time frame: Up to 2.5 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
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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.
Rémi Rabasa-Lhoret principal investigator
Institut de Recherches Cliniques de Montreal
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 Hypoglycaemic hyperinsulinemic clamp and Glucagon in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 4 Dec 2013. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Incremental area under the curve of plasma glucose concentrations (time frame: 30 minutes). 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 4 Dec 2013.