Type 1 DiabetesPhase 1NCT01201278
PK/PD Study of Intranasal Insulin in Type I Diabetes
A Phase 1 study testing Insulin and Insulin LISPRO in people with Type 1 Diabetes, run by Hompesch, Marcus, M.D. at 1 site in United States.
Trial summary
This study is designed to compare the safety and tolerability of two different doses of intranasally administered regular human insulin with those of a single dose of the rapid-acting insulin analog lispro Humalog® after subcutaneous injection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Insulin and Insulin LISPRO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 and female subjects with type 1 diabetes between the ages of 18 and 65 years, inclusive.
- Type 1 diabetes clinically diagnosed ≥ 12 months.
- Treated with multiple daily insulin injections ≥ 12 months or an insulin pump.
- HbA1c ≤ 10 % by local laboratory analysis (one retest within a week is permitted with the result of the last test being conclusive).
- Fasting serum C-peptide ≤ 0.3 nmol/L.
- BMI between 18-28 kg/m², inclusive.
- Signed, written IRB-approved informed consent.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, oncologic, or neurologic (to include history of seizures) disease; hypoglycemic episodes; intercurrent illness (such as influenza); or allergic disease (including severe drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Clinical significance to be determined by the PI.
- History of recent nose bleed, history of nasal polyps, nasal surgery other than cosmetic rhinoplasty or cauterization.
- As judged by the investigator, clinically significant findings in laboratory data. (Anemia with hematocrit less than 33% at screening is specifically exclusionary.)
- Clinically significant abnormal ECG at screening, as judged by the Investigator.
- Clinically significant abnormalities in vital signs at screening, as judged by the Investigator.
- Known allergy to trial product or any other ingredient in the study drug.
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- Positive HIV 1 (human immunodeficiency virus) antibody test, hepatitis B (anti-HBsAg) or hepatitis C (anti-HCV) antibody test.
- History or evidence of alcohol or drug abuse within the past 3 years.
- History of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children) as judged by the Investigator.
- Use of drugs that may interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action or glucose utilization.
- Blood donation or high volume phlebotomy, e.g., >500 mL, within 56 days before dosing.
- Participation in a study of any investigational drug or device 30 days before enrollment in this study.
- The subject is unfit for the study in the opinion of the investigator.
- Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilization, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomized partner).
Trial locations and contacts
1 site in 1 country.
United States1 site
Profil Institute for Clinical Research
Chula Vista, California, 91911
Marcus Hompesch, MD
About this study
Official title: A Phase 1, Randomized, 3-Way Crossover, Investigator Initiated Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Two Doses of Intranasally Administered Regular Human Insulin Compared to a Single Dose of a Subcutaneously Injected Rapid Acting Insulin Analog (Humalog®) in Subjects With Type I Diabetes
This study is designed to compare the safety and tolerability of two different doses of intranasally administered regular human insulin with those of a single dose of the rapid-acting insulin analog lispro Humalog® after subcutaneous injection. In addition to safety and tolerability, various pharmacokinetic (PK) and pharmacodynamic (PD) parameters will be evaluated by means of the euglycemic glucose clamp technique.
- Conditions
- Type 1 Diabetes
- Being tested
- Insulin, Insulin LISPRO
- Keywords
- intranasal insulin
- 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.
InsulinDrug
Nasal insulin at a dose estimated to be equivalent to 8 IU bioavailable insulin
InsulinDrug
Nasal insulin at a dose estimated to be equivalent to 16 IU bioavailable insulin
Insulin LISPRODrug
Subcutaneous insulin lispro 8 U
| Study group | Role | What they receive |
|---|---|---|
| Nasal insulin 8 IU | Experimental | Nasal insulin at a dose estimated to be equivalent to 8 IU bioavailable insulin Receives: Drug: Insulin |
| Nasal insulin 16 IU | Experimental | Nasal insulin at a dose estimated to be equivalent to 16 IU bioavailable insulin Receives: Drug: Insulin |
| Subcutaneous insulin lispro 8 U | Active comparator | Subcutaneous insulin lispro (Humalog®) 8 U Receives: Drug: Insulin LISPRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin tolerability, PK, and PD
To assess safety and tolerability, and to compare the insulin AUC over 0-120 min for each of the three insulin applications.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hompesch, Marcus, M.D.
- Collaborators
- Profil Institute for Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201278
- Sponsor's protocol ID
- NI2010-001
- Status last verified
- Jun 2011
- First submitted
- 13 Sep 2010
- Last updated
- 17 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, 3-Way Crossover, Investigator Initiated Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Two Doses of Intranasally Administered Regular Human Insulin Compared to a Single Dose of a Subcutaneously Injected Rapid Acting Insulin Analog (Humalog®) in Subjects With Type I Diabetes
- ClinicalTrials.gov ID
- NCT01201278
- Acronym / sponsor ID
- NI2010-001
- Conditions
- Type 1 Diabetes
- Keywords
- intranasal insulin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hompesch, Marcus, M.D.
- Collaborators
- Profil Institute for Clinical Research, Inc.
- First posted
- 14 Sep 2010 (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.
This study is designed to compare the safety and tolerability of two different doses of intranasally administered regular human insulin with those of a single dose of the rapid-acting insulin analog lispro Humalog® after subcutaneous injection. In addition to safety and tolerability, various pharmacokinetic (PK) and pharmacodynamic (PD) parameters will be evaluated by means of the euglycemic glucose clamp technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nasal insulin 8 IU | Experimental | Drug: InsulinNasal insulin at a dose estimated to be equivalent to 8 IU bioavailable insulin |
| Nasal insulin 16 IU | Experimental | Drug: InsulinNasal insulin at a dose estimated to be equivalent to 16 IU bioavailable insulin |
| Subcutaneous insulin lispro 8 U | Active comparator | Drug: Insulin LISPROSubcutaneous insulin lispro (Humalog®) 8 U |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subjects with type 1 diabetes between the ages of 18 and 65 years, inclusive.
- Type 1 diabetes clinically diagnosed ≥ 12 months.
- Treated with multiple daily insulin injections ≥ 12 months or an insulin pump.
- HbA1c ≤ 10 % by local laboratory analysis (one retest within a week is permitted with the result of the last test being conclusive).
- Fasting serum C-peptide ≤ 0.3 nmol/L.
Key exclusion criteria (14 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, oncologic, or neurologic (to include history of seizures) disease; hypoglycemic episodes; intercurrent illness (such as influenza); or allergic disease (including severe drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Clinical significance to be determined by the PI.
- History of recent nose bleed, history of nasal polyps, nasal surgery other than cosmetic rhinoplasty or cauterization.
- As judged by the investigator, clinically significant findings in laboratory data. (Anemia with hematocrit less than 33% at screening is specifically exclusionary.)
- Clinically significant abnormal ECG at screening, as judged by the Investigator.
- Clinically significant abnormalities in vital signs at screening, as judged by the Investigator.
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 |
|---|---|---|
| InsulinNasal insulin at a dose estimated to be equivalent to 8 IU bioavailable insulin | Drug | Nasal insulin 8 IU |
| InsulinNasal insulin at a dose estimated to be equivalent to 16 IU bioavailable insulin | Drug | Nasal insulin 16 IU |
| Insulin LISPROSubcutaneous insulin lispro 8 U | Drug | Subcutaneous insulin lispro 8 U |
Primary outcome
Insulin tolerability, PK, and PD
Time frame: 120 minutes
To assess safety and tolerability, and to compare the insulin AUC over 0-120 min for each of the three insulin applications.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2011.
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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.
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 Insulin and Insulin LISPRO in people with Type 1 Diabetes, run by Hompesch, Marcus, M.D. at 1 site in United States.
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 14 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 17 Jun 2011. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcus Hompesch, MD ((619) 427-1300, marcus.hompesch@profilinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin tolerability, PK, and PD (time frame: 120 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 17 Jun 2011.