Diabetes Mellitus Type 1Phase 1NCT01916265
Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages
A Phase 1 study testing Glucagon in people with Diabetes Mellitus Type 1, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
Trial summary
The ultimate goal of the PCDIAB project is to develop a bi-hormonal pump (insulin and glucagon) substituting for the pancreas and facilitating tight euglycemic control in patients with T1DM. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Nov 2013
- Phase
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects with diabetes mellitus type 1 , as defined by the American Diabetes Association1.
- Age ≥ 18 and ≤ 65 years.
Who cannot join
- Known or suspected hypersensitivity to trial product(s) or related products.
- Receipt of any investigational medicinal product within 3 months or 5 half-lives of that IMP before randomisation in this trial.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Profil Institut für Stoffwechselforschung GmbH
Neuss, North Rhine-Westphalia, 41460
About this study
Official title: A Randomised, Single Center, Three-period Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages at Four Different Blood Glucose Concentrations
The ultimate goal of the PCDIAB project is to develop a bi-hormonal pump (insulin and glucagon) substituting for the pancreas and facilitating tight euglycemic control in patients with T1DM.
Read the detailed description
The study is planned as open, randomised 3-period cross-over in patients with T1DM. The study will include a total of 6 completing patients. The study is not blinded due to the exploratory nature.
At each of the 3 periods, different blood glucose level will be established in 4 steps (8, 6, 4, and 2.8 mmol/L), and a prefixed glucagon dose will be given per glucose level. The sequence of glucagon dose strength for the three dosing days will be randomized.
- Conditions
- Diabetes Mellitus Type 1
- Being tested
- Glucagon
- 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
| Study group | Role | What they receive |
|---|---|---|
| Glucagon level: 0,11 and 1 mg | Experimental | Glucagon level: 0,11 and 1 mg Receives: Drug: Glucagon |
| Glucagon level: 0,22 and 0,66 mg | Experimental | Glucagon level: 0,22 and 0,66 mg Receives: Drug: Glucagon |
| Glucagon level: 0,44 and 0,33 mg | Experimental | Glucagon level: 0,44 and 0,33 mg Receives: Drug: Glucagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCGlucose of different glucagon dosages given s.c.
Measured: 90 min after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionNov 2013
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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Union
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916265
- Sponsor's protocol ID
- PCDiab01
- Status last verified
- Aug 2013
- First submitted
- 25 Jul 2013
- Last updated
- 5 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single Center, Three-period Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages at Four Different Blood Glucose Concentrations
- ClinicalTrials.gov ID
- NCT01916265
- Acronym / sponsor ID
- PCDiab01
- Conditions
- Diabetes Mellitus Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbHIndustry (pharma, biotech, devices)
- Collaborators
- European Union
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Aug 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.
The ultimate goal of the PCDIAB project is to develop a bi-hormonal pump (insulin and glucagon) substituting for the pancreas and facilitating tight euglycemic control in patients with T1DM.
Detailed description
The study is planned as open, randomised 3-period cross-over in patients with T1DM. The study will include a total of 6 completing patients. The study is not blinded due to the exploratory nature.
At each of the 3 periods, different blood glucose level will be established in 4 steps (8, 6, 4, and 2.8 mmol/L), and a prefixed glucagon dose will be given per glucose level. The sequence of glucagon dose strength for the three dosing days will be randomized.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glucagon level: 0,11 and 1 mg | Experimental | Drug: GlucagonGlucagon level: 0,11 and 1 mg |
| Glucagon level: 0,22 and 0,66 mg | Experimental | Drug: GlucagonGlucagon level: 0,22 and 0,66 mg |
| Glucagon level: 0,44 and 0,33 mg | Experimental | Drug: GlucagonGlucagon level: 0,44 and 0,33 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female subjects with diabetes mellitus type 1 , as defined by the American Diabetes Association1.
- Age ≥ 18 and ≤ 65 years.
Key exclusion criteria (2 listed)
- Known or suspected hypersensitivity to trial product(s) or related products.
- Receipt of any investigational medicinal product within 3 months or 5 half-lives of that IMP before randomisation in this trial.
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 |
|---|---|---|
| Glucagon | Drug | Glucagon level: 0,11 and 1 mg, Glucagon level: 0,22 and 0,66 mg, Glucagon level: 0,44 and 0,33 mg |
Primary outcome
AUCGlucose of different glucagon dosages given s.c.
Time frame: 90 min after dosing
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 5 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glucagon in people with Diabetes Mellitus Type 1, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
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 2 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 5 Feb 2014. 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
AUCGlucose of different glucagon dosages given s.c. (time frame: 90 min after dosing). 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 5 Feb 2014; AzTrials last refreshed its copy on 7 Nov 2026.