Type 1 Diabetes MellitusPhase 1NCT03916640
A Trial to Assess a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus
A Phase 1 study testing ADO09 formulation, Symlin® and Humulin® in people with Type 1 Diabetes Mellitus, run by Adocia at 1 site in Germany.
Trial summary
This trial is a monocentric, randomised, double-blind, active comparator, controlled, 3-period cross-over trial. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- ADO09 formulation, Symlin® and Humulin®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jan 2019to 1 Mar 2019
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 Diabetes Mellitus (as diagnosed clinically) ≥ 12 months
- Treated with multiple daily injection ≥ 12 months
- Treated with insulin glargine U100 or U300 or insulin detemir at screening
- Fasting C-peptide ≤ 0.30 nmol/L
- BMI: 18.5-28.0 kg/m² (both inclusive)
Who cannot join
- Known or suspected hypersensitivity to IMPs, paracetamol or related products
- Type 2 Diabetes Mellitus
- Clinically significant abnormal haematology, biochemistry or urinalysis screening test, as judged by the investigator considering the underlying disease
- Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the investigator
- Known slowing of gastric emptying, including gastroparesis and or gastrointestinal surgery that in the opinion of the investigator, might change gastrointestinal motility and food absorption
- Intake of medication known to affect gastrointestinal motility, including but not limited to erythromycin, metoclopramide, cisapride, cholestyramine or colestipol within 4 weeks before screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus
This trial is a monocentric, randomised, double-blind, active comparator, controlled, 3-period cross-over trial.
Read the detailed description
In this monocentric, randomised, double-blind, active comparator, controlled, cross-over trial, each patient will be randomly allocated to a sequence of three treatments: one single dose of the co-formulation of insulin analog and pramlintide (also called ADO09), simultaneous separate injections of pramlintide and human insulin and one single dose of insulin lispro. To keep the blinding in this trial, a placebo injection will be given in addition to the ADO09 formulation and insulin lispro dose for a total of 2 injections per dosing visit. During each visit, meal test procedures will be performed and subjects will stay at the clinical centre until post-dose follow-up period has been terminated. IMP administration will be done subcutaneously immediately prior to test meal intake.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- ADO09 formulation, Placebo, Symlin®, Humulin®, Humalog®
- 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.
ADO09 formulationDrug
Subcutaneous injection of ADO09 formulation
PlaceboDrug
Subcutaneous injection of 0.9% NaCl
Symlin®Drug
Subcutaneous injection of pramlintide
Humulin®Drug
Subcutaneous injection of human insulin
Humalog®Drug
Subcutaneous injection of insulin lispro
| Study group | Role | What they receive |
|---|---|---|
| Co-formulation of insulin analog and pramlintide (ADO09) | Experimental | Subcutaneous injection of ADO09 formulation + injection of placebo (0.9% NaCl) to ensure double dummy. Receives: Drug: ADO09 formulation; Drug: Placebo |
| Humulin® + Symlin® | Active comparator | Simultaneous, separate subcutaneous injections of human insulin and pramlintide. Receives: Drug: Symlin®; Drug: Humulin® |
| Humalog® | Active comparator | Subcutaneous injection of insulin lispro + injection of placebo (0.9% NaCl) to ensure double dummy. Receives: Drug: Placebo; Drug: Humalog® |
What is being measured
The primary outcome is the main question the study is designed to answer.
CmaxPram
Maximum pramlintide concentration
Measured: From 0 to 8 hours
AUCPram 0-8h
Area under the pramlintide concentration-time curve from 0-8 hours after IMP administration
Measured: From 0 to 8 hours
CmaxIns
Maximum insulin analog concentration
Measured: From 0 to 8 hours
AUCIns 0-8h
Area under the insulin analog concentration-time curve from 0-8 hours after IMP administration
Measured: From 0 to 8 hours
Secondary outcomes (4)
Pharmacokinetics of pramlintide
Area under the pramlintide concentration-time curve
Measured: From 0 to 8 hours
Pharmacokinetics of insulins
Area under the insulins concentration-time curve
Measured: From 0 to 8 hours
Glucose pharmacodynamics
Area under the blood glucose concentration-time curve
Measured: From 0 to 8 hours
Safety and tolerability (Adverse Events recording)
Number of Adverse Events
Measured: From 0 to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start4 Jan 2019
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grit Andersen, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916640
- Sponsor's protocol ID
- CT034-ADO09
- Status last verified
- Apr 2019
- First submitted
- 12 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03916640
- Acronym / sponsor ID
- CT034-ADO09
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 16 Apr 2019 (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 trial is a monocentric, randomised, double-blind, active comparator, controlled, 3-period cross-over trial.
Detailed description
In this monocentric, randomised, double-blind, active comparator, controlled, cross-over trial, each patient will be randomly allocated to a sequence of three treatments: one single dose of the co-formulation of insulin analog and pramlintide (also called ADO09), simultaneous separate injections of pramlintide and human insulin and one single dose of insulin lispro. To keep the blinding in this trial, a placebo injection will be given in addition to the ADO09 formulation and insulin lispro dose for a total of 2 injections per dosing visit. During each visit, meal test procedures will be performed and subjects will stay at the clinical centre until post-dose follow-up period has been terminated. IMP administration will be done subcutaneously immediately prior to test meal intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Co-formulation of insulin analog and pramlintide (ADO09) | Experimental | Drug: ADO09 formulation, Drug: PlaceboSubcutaneous injection of ADO09 formulation + injection of placebo (0.9% NaCl) to ensure double dummy. |
| Humulin® + Symlin® | Active comparator | Drug: Symlin®, Drug: Humulin®Simultaneous, separate subcutaneous injections of human insulin and pramlintide. |
| Humalog® | Active comparator | Drug: Placebo, Drug: Humalog®Subcutaneous injection of insulin lispro + injection of placebo (0.9% NaCl) to ensure double dummy. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Type 1 Diabetes Mellitus (as diagnosed clinically) ≥ 12 months
- Treated with multiple daily injection ≥ 12 months
- Treated with insulin glargine U100 or U300 or insulin detemir at screening
- Fasting C-peptide ≤ 0.30 nmol/L
- BMI: 18.5-28.0 kg/m² (both inclusive)
Key exclusion criteria (6 listed)
- Known or suspected hypersensitivity to IMPs, paracetamol or related products
- Type 2 Diabetes Mellitus
- Clinically significant abnormal haematology, biochemistry or urinalysis screening test, as judged by the investigator considering the underlying disease
- Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the investigator
- Known slowing of gastric emptying, including gastroparesis and or gastrointestinal surgery that in the opinion of the investigator, might change gastrointestinal motility and food absorption
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 |
|---|---|---|
| ADO09 formulationSubcutaneous injection of ADO09 formulation | Drug | Co-formulation of insulin analog and pramlintide (ADO09) |
| PlaceboSubcutaneous injection of 0.9% NaCl | Drug | Co-formulation of insulin analog and pramlintide (ADO09), Humalog® |
| Symlin®Subcutaneous injection of pramlintide | Drug | Humulin® + Symlin® |
| Humulin®Subcutaneous injection of human insulin | Drug | Humulin® + Symlin® |
| Humalog®Subcutaneous injection of insulin lispro | Drug | Humalog® |
Primary outcome
CmaxPram
Time frame: From 0 to 8 hours
Maximum pramlintide concentration
AUCPram 0-8h
Time frame: From 0 to 8 hours
Area under the pramlintide concentration-time curve from 0-8 hours after IMP administration
CmaxIns
Time frame: From 0 to 8 hours
Maximum insulin analog concentration
AUCIns 0-8h
Time frame: From 0 to 8 hours
Area under the insulin analog concentration-time curve from 0-8 hours after IMP administration
4 secondary outcomes
Pharmacokinetics of pramlintide
Time frame: From 0 to 8 hours
Pharmacokinetics of insulins
Time frame: From 0 to 8 hours
Glucose pharmacodynamics
Time frame: From 0 to 8 hours
Safety and tolerability (Adverse Events recording)
Time frame: From 0 to 8 hours
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 16 Apr 2019.
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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.
Grit Andersen, MD principal investigator
Profil Institut für Stoffwechselforschung GmbH
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 ADO09 formulation, Symlin® and Humulin® in people with Type 1 Diabetes Mellitus, run by Adocia 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 5 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: finished, as of the sponsor's last update on 16 Apr 2019. 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?
CmaxPram (time frame: From 0 to 8 hours). The study lists 4 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 16 Apr 2019.