Type 1 Diabetes MellitusPhase 1NCT02206568
Pharmacokinetics of Ultra-Rapid-Acting Insulin Lispro (URAL) in Type 1 Diabetes Mellitus
A Phase 1 study testing URAL in people with Type 1 Diabetes Mellitus, run by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc. at 1 site in Germany.
Trial summary
To compare the early pharmacokinetic exposure of URAL and insulin lispro (ILisp). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- URAL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Sep 2014
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Male subjects age 18-65 years inclusive
- Type 1 diabetes mellitus diagnosed clinically >= 12 months
- Treatment with multiple daily insulin injections or CSII >= 12 months
- Current total daily insulin treatment <1.2 (I)U/kg/day
- Current total daily bolus insulin treatment <0.7 (I)U/kg/day
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- Body mass index 18.0-30.0 kg/m2 inclusive
- HbA1c =<9.0% by local laboratory analysis (one retest within a week is permitted with the result of the last test being conclusive)
- C-peptide =< 0.30 nmol/L
Who cannot join
- Known or suspected hypersensitivity to trial products or related products
- Previous participation in this trial. .
- Receipt of any non-marketed investigational product within 3 months
- Clinically significant abnormal haematology, biochemistry, liver enzymes, or coagulation screening tests
- Suffer from or history of a life threatening disease or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal , neurological, psychiatric diseases or other major disorders
- History of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in 1st degree relatives
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- Cardiac problems defined as decompensated heart failure (New York Heart Association class III and IV) at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time.
- Supine blood pressure at screening outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic . Pulse outside 50 to 90 bpm.
- Clinically significant abnormal ECG at screening.
- Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy.
- Any disease or condition that, in the opinion of the Investigator, would represent an unacceptable risk for the subject's safety.
- Subject positive for HBs-Ag, HCV-Ab
- Positive result to the screening test for HIV-1 antibodies, HIV-2 antibodies, or HIV-1 antigen according to locally used diagnostic testing.
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- Subject who has donated blood or plasma in the past month or more than 500 mL within 3 months.
- Surgery or trauma with significant blood loss (more than 500 mL) within 3 months.
- Current treatment with systemic (oral, IV, or inhaled) corticosteroids, monoamine oxidase inhibitors, NSAID, prostaglandin blockers, systemic non-selective beta-blockers, growth hormone (last 3 months), non-routine vitamins or herbal products (last 2 weeks). Thyroid hormones are not allowed unless the use of these has been stable during the last 3 months. Routine vitamins are permitted up to 48 hours prior to dosing.
- Significant history of alcoholism and/or drug/chemical abuse as per Investigator's judgement or a positive result in the urine drug/alcohol breath test screen at the screening visit.
- Heavy smoker
- Not able or willing to refrain from smoking and use of nicotine.
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemia event during the last 12 months) or hypoglycaemic unawareness.
- Subject with mental incapacity or language barriers precluding adequate understanding.
- Potentially non-compliant or uncooperative during the trial.
- Any condition that would interfere with trial participation or evaluation of results.
- No relevant lipodystrophy within the area of drug administration and Doppler sonography.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Trial Investigating Pharmacokinetic Properties of Ultra-Rapid-Acting Insulin Lispro (URAL) in Subjects With Type 1 Diabetes Mellitus
To compare the early pharmacokinetic exposure of URAL and insulin lispro (ILisp).
Read the detailed description
To compare the total pharmacodynamic response of URAL and insulin lispro.
To compare the total pharmacokinetic exposure between URAL and insulin lispro.
To assess the safety and tolerability of URAL and insulin lispro.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- URAL
- Keywords
- diabetes mellitus, phase 1, insulin lispro, male subjects
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
URALDrug
Also called Ultra-Rapid-Acting Insulin Lispro
| Study group | Role | What they receive |
|---|---|---|
| URAL vs. Insulin lispro | Experimental | Each subject will randomly be allocated to a treatment sequence consisting of 2 dosing visits during which the subject in a euglycaemic clamp setting will receive either a single dose of insulin lispro or URAL at predefined fixed dose levels in a randomized order. Receives: Drug: URAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of URAL
Area under the serum insulin lispro concentration-time curve from 0-30 minutes after administration
Measured: 1 day
Secondary outcomes (2)
Onset of appearance of serum insulin lispro
Measurement of time to reach insulin lispro concentration >30 pmol/L in the serum
Measured: 1 day
Number of subjects with adverse events
Assessment of safety and tolerability of URAL
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2014
- Study completionSep 2014
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH
- Responsible party
- Sponsor
- Investigators
- Alin Stirban, MD, Principal investigator, Profil Institut fur Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206568
- Sponsor's protocol ID
- PER511
- Status last verified
- May 2015
- First submitted
- 30 Jul 2014
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial Investigating Pharmacokinetic Properties of Ultra-Rapid-Acting Insulin Lispro (URAL) in Subjects With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02206568
- Acronym / sponsor ID
- PER511
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- diabetes mellitus, phase 1, insulin lispro, male subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 1 Aug 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.
To compare the early pharmacokinetic exposure of URAL and insulin lispro (ILisp).
Detailed description
To compare the total pharmacodynamic response of URAL and insulin lispro.
To compare the total pharmacokinetic exposure between URAL and insulin lispro.
To assess the safety and tolerability of URAL and insulin lispro.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| URAL vs. Insulin lispro | Experimental | Drug: URALEach subject will randomly be allocated to a treatment sequence consisting of 2 dosing visits during which the subject in a euglycaemic clamp setting will receive either a single dose of insulin lispro or URAL at predefined fixed dose levels in a randomized order. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent
- Male subjects age 18-65 years inclusive
- Type 1 diabetes mellitus diagnosed clinically >= 12 months
- Treatment with multiple daily insulin injections or CSII >= 12 months
- Current total daily insulin treatment <1.2 (I)U/kg/day
Key exclusion criteria (25 listed)
- Known or suspected hypersensitivity to trial products or related products
- Previous participation in this trial. .
- Receipt of any non-marketed investigational product within 3 months
- Clinically significant abnormal haematology, biochemistry, liver enzymes, or coagulation screening tests
- Suffer from or history of a life threatening disease or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal , neurological, psychiatric diseases or other major disorders
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 |
|---|---|---|
| URALAlso: Ultra-Rapid-Acting Insulin Lispro | Drug | URAL vs. Insulin lispro |
Primary outcome
Pharmacokinetics of URAL
Time frame: 1 day
Area under the serum insulin lispro concentration-time curve from 0-30 minutes after administration
2 secondary outcomes
Onset of appearance of serum insulin lispro
Time frame: 1 day
Number of subjects with adverse events
Time frame: 1 day
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 15 Jul 2020.
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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.
Alin Stirban, MD principal investigator
Profil Institut fur 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 URAL in people with Type 1 Diabetes Mellitus, run by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc. 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 9 inclusion and 25 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 15 Jul 2020. 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 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?
Pharmacokinetics of URAL (time frame: 1 day). 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 15 Jul 2020.