Diabetes Mellitus, Type 1Phase 4GluST1NCT02232971
Treatment of Low Blood Sugar With Glucagon Among Patients With Type 1 Diabetes
A Phase 4 study testing Glucagon and Isotonic saline solution in people with Diabetes Mellitus, Type 1, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Background: Patients with type 1 diabetes (T1D) need a lifelong supply of external insulin and are advised to aim for near-normalization of blood glucose levels through intensive insulin therapy. We propose a new approach for achieving treatment goals in T1D: the combined use of insulin and glucagon, i.e. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Glucagon and Isotonic saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Jul 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18-65 years
- Diagnosed with type 1 diabetes > 3 years
- HbA1c < 58 mmol/mol
- No appearance of autonome neuropathy
- Body mass index (BMI) between 20-25 kg/m2
- Remained hypoglycemic awareness
- Insulin pump treatment > 1 year
Who cannot join
- Allergic to glucagon or lactose
- Pregnancy, breast-feeding, intention of becoming pregnant, or not using adequate contraception
- Any disease or condition which would interfere with the subject's safety
- Use of a medication that significantly impacts glucose metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Hypoglycemia With Glucagon Among Patients With Type 1 Diabetes Mellitus
Background: Patients with type 1 diabetes (T1D) need a lifelong supply of external insulin and are advised to aim for near-normalization of blood glucose levels through intensive insulin therapy. We propose a new approach for achieving treatment goals in T1D: the combined use of insulin and glucagon, i.e. dual-hormone treatment.Only recently the prospect of treating patients with soluble glucagon has arisen and thus studies of low dose glucagon treatment of mild hypoglycemia are needed to determine whether there is clinical rationale for dual-hormone treatment of T1D.
Aim: The purpose of this clinical study is to investigate the glycemic response to subcutaneous glucagon administration during mild hypoglycemia in T1D patients treated with insulin pump. Different glucagon doses are applied to determine the most appropriate dose for future dual-hormone treatment of T1D.
Read more
Methods: A clinical, randomized, single blinded, crossover study will be conducted. Eight T1D patients treated with insulin pump are studied on four days. All patients are in good metabolic control (HbA1c < 7.5%), C-peptide negative and with hypoglycemia awareness. On each study day, hypoglycemia is induced with subcutaneously insulin and afterward treated with a single subcutaneous dose of glucagon. The study procedures are identical on all days except from the administered dose of glucagon (day 1: placebo, day 2: 100 ug, day 3: 200 ug, day 4: 300 ug). All patients are blinded for the glucagon dose and carry out the four days in random order.
Endpoints: The present study focuses primarily on the dose related plasma glucose response of glucagon; secondary on the duration of the hyperglycemic effect of glucagon and tertiary the glucagon effect on catecholamine, cortisol, growth hormone, free fatty acids and triglycerides.
The study will be conducted from august 2014.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Glucagon, Isotonic saline solution
- Keywords
- glucagon, insulin pump, artificial pancreas, closed-loop
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucagonDrug
Also called GlucaGen (r), Disp. no. 2514, Novo Nordisk A/S, Novo Allé
Glucagon is given in three different doses according to three research days.
Isotonic saline solutionOther
Also called Natriumklorid isotonisk "SAD", D.sp.no. 6733, Amgros I/S, Dampfærgevej 22
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Isotonic Saline Receives: Other: Isotonic saline solution |
| Glucagon 0.1 mg | Experimental | GlucaGen(r) 0.1 mg administration Receives: Drug: Glucagon |
| Glucagon 0.2 mg | Experimental | GlucaGen(r) 0.2 mg administration Receives: Drug: Glucagon |
| Glucagon 0.3 mg | Experimental | GlucaGen(r) 0.3 mg administration Receives: Drug: Glucagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma glucose response
Measured: Plasma glucose measured every five minutes after administration
Secondary outcomes (1)
Duration of hyperglycemic effect of glucagon
Measured: Plasma glucose is measured every five minutes. Time period is two -three hours after glucagon administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2015
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Novo Nordic Foundation, University of Copenhagen
- Responsible party
- Principal investigator, Ajenthen Ranjan, Hvidovre University Hospital
- Investigators
- Ajenthen Ranjan, MD, Principal investigator, Hvidovre University HospitalSigne Schmidt, MD, PhD, Study director, Hvidovre University HospitalKirsten Nørgaard, MD, DMSc, Study chair, Hvidovre University HospitalSten Madsbad, Prof, DMSc, Study chair, Hvidovre University HospitalJens J Holst, Prof, DMSc, Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232971
- Sponsor's protocol ID
- GluST1_2014
- Other IDs
- 2014-002267-15, H-1-2014-041, 2014
- Acronym
- GluST1
- Status last verified
- Mar 2015
- First submitted
- 29 Aug 2014
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hypoglycemia With Glucagon Among Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02232971
- Acronym / sponsor ID
- GluST1 / GluST1_2014
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- glucagon, insulin pump, artificial pancreas, closed-loop
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- The Novo Nordic Foundation, University of Copenhagen
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jul 2015 (estimated)
- First posted
- 5 Sep 2014 (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.
Background: Patients with type 1 diabetes (T1D) need a lifelong supply of external insulin and are advised to aim for near-normalization of blood glucose levels through intensive insulin therapy. We propose a new approach for achieving treatment goals in T1D: the combined use of insulin and glucagon, i.e. dual-hormone treatment.Only recently the prospect of treating patients with soluble glucagon has arisen and thus studies of low dose glucagon treatment of mild hypoglycemia are needed to determine whether there is clinical rationale for dual-hormone treatment of T1D.
Aim: The purpose of this clinical study is to investigate the glycemic response to subcutaneous glucagon administration during mild hypoglycemia in T1D patients treated with insulin pump. Different glucagon doses are applied to determine the most appropriate dose for future dual-hormone treatment of T1D.
Methods: A clinical, randomized, single blinded, crossover study will be conducted. Eight T1D patients treated with insulin pump are studied on four days. All patients are in good metabolic control (HbA1c < 7.5%), C-peptide negative and with hypoglycemia awareness. On each study day, hypoglycemia is induced with subcutaneously insulin and afterward treated with a single subcutaneous dose of glucagon. The study procedures are identical on all days except from the administered dose of glucagon (day 1: placebo, day 2: 100 ug, day 3: 200 ug, day 4: 300 ug). All patients are blinded for the glucagon dose and carry out the four days in random order.
Endpoints: The present study focuses primarily on the dose related plasma glucose response of glucagon; secondary on the duration of the hyperglycemic effect of glucagon and tertiary the glucagon effect on catecholamine, cortisol, growth hormone, free fatty acids and triglycerides.
The study will be conducted from august 2014.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Isotonic saline solutionIsotonic Saline |
| Glucagon 0.1 mg | Experimental | Drug: GlucagonGlucaGen(r) 0.1 mg administration |
| Glucagon 0.2 mg | Experimental | Drug: GlucagonGlucaGen(r) 0.2 mg administration |
| Glucagon 0.3 mg | Experimental | Drug: GlucagonGlucaGen(r) 0.3 mg administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females aged 18-65 years
- Diagnosed with type 1 diabetes > 3 years
- HbA1c < 58 mmol/mol
- No appearance of autonome neuropathy
- Body mass index (BMI) between 20-25 kg/m2
Key exclusion criteria (4 listed)
- Allergic to glucagon or lactose
- Pregnancy, breast-feeding, intention of becoming pregnant, or not using adequate contraception
- Any disease or condition which would interfere with the subject's safety
- Use of a medication that significantly impacts glucose metabolism
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 (r), Disp. no. 2514, Novo Nordisk A/S, Novo AlléGlucagon is given in three different doses according to three research days. | Drug | Glucagon 0.1 mg, Glucagon 0.2 mg, Glucagon 0.3 mg |
| Isotonic saline solutionAlso: Natriumklorid isotonisk "SAD", D.sp.no. 6733, Amgros I/S, Dampfærgevej 22Placebo | Other | Placebo |
Primary outcome
Maximum plasma glucose response
Time frame: Plasma glucose measured every five minutes after administration
1 secondary outcome
Duration of hyperglycemic effect of glucagon
Time frame: Plasma glucose is measured every five minutes. Time period is two -three hours after glucagon administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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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
Signe Schmidt, MD, PhD study director
Hvidovre University Hospital
Kirsten Nørgaard, MD, DMSc study chair
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 Glucagon and Isotonic saline solution in people with 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Mar 2015. 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?
Results are not available in the source record.
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?
Maximum plasma glucose response (time frame: Plasma glucose measured every five minutes after administration). 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 25 Mar 2015.