Type 1 DiabetesPhase 1NCT01811849
Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes
A Phase 1 study testing Insulin LISPRO in people with Type 1 Diabetes, run by Biodel.
Trial summary
A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects with Type 1 Diabetes Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Insulin LISPRO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Dec 2012
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 to ≤70 years
- Body Mass Index: ≥18 and ≤35 kg/m2
- Diagnosed with Type 1 Diabetes Mellitus for at least 1 year
Who cannot join
- Type 2 diabetes mellitus
- Serum C-peptide >1.0 ng/mL
- HbA1c >10.0%
- History of hypersensitivity to any of the components in the study medication
- Treatment with any other investigational drug in the last 30 days before dosing.
- Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety, protocol compliance, or interpretation of study results. Caffeine, nicotine or alcohol addiction which might be expected to result in withdrawal symptoms during the course of a study dosing day would fall into this category.
About this study
Official title: A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration
A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects with Type 1 Diabetes
Read the detailed description
The purpose of this study is to assess the speed of absorption of BIOD-238 and BIOD-250 compared to Humalog®. Secondary objectives are to assess other pharmacokinetic characteristics of BIOD-238 and BIOD-250 compared to Humalog®, and to evaluate the safety and tolerability of BIOD-238 and BIOD-250 compared to Humalog®.
- Conditions
- Type 1 Diabetes
- Being tested
- Insulin LISPRO
- Keywords
- diabetes
- 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.
Insulin LISPRODrug
Insulin LISPRODrug
Insulin LISPRODrug
| Study group | Role | What they receive |
|---|---|---|
| BIOD-238 | Experimental | Subcutaneous injection Receives: Drug: Insulin LISPRO |
| BIOD-250 | Experimental | Subcutaneous injection Receives: Drug: Insulin LISPRO |
| Humalog | Active comparator | Subcutaneous injection Receives: Drug: Insulin LISPRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to 1/2 maximal insulin concentration
Measured: 480 minutes
Secondary outcomes (4)
Time to maximal insulin concentration
Measured: 480 minutes
Time to 1/2 maximal insulin concentration after peak
Measured: 480 minutes
Visual analog scale
Measured: 30 minutes
AUC 0-30 and AUC 0-60
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2013 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionDec 2012
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biodel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811849
- Sponsor's protocol ID
- 4-102
- Status last verified
- Mar 2013
- First submitted
- 13 Mar 2013
- Last updated
- 15 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration
- ClinicalTrials.gov ID
- NCT01811849
- Acronym / sponsor ID
- 4-102
- Conditions
- Type 1 Diabetes
- Keywords
- diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- BiodelIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Mar 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.
A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects with Type 1 Diabetes
Detailed description
The purpose of this study is to assess the speed of absorption of BIOD-238 and BIOD-250 compared to Humalog®. Secondary objectives are to assess other pharmacokinetic characteristics of BIOD-238 and BIOD-250 compared to Humalog®, and to evaluate the safety and tolerability of BIOD-238 and BIOD-250 compared to Humalog®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIOD-238 | Experimental | Drug: Insulin LISPROSubcutaneous injection |
| BIOD-250 | Experimental | Drug: Insulin LISPROSubcutaneous injection |
| Humalog | Active comparator | Drug: Insulin LISPROSubcutaneous injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: ≥18 to ≤70 years
- Body Mass Index: ≥18 and ≤35 kg/m2
- Diagnosed with Type 1 Diabetes Mellitus for at least 1 year
Key exclusion criteria (6 listed)
- Type 2 diabetes mellitus
- Serum C-peptide >1.0 ng/mL
- HbA1c >10.0%
- History of hypersensitivity to any of the components in the study medication
- Treatment with any other investigational drug in the last 30 days before dosing.
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 |
|---|---|---|
| Insulin LISPRO | Drug | BIOD-238 |
| Insulin LISPRO | Drug | BIOD-250 |
| Insulin LISPRO | Drug | Humalog |
Primary outcome
Time to 1/2 maximal insulin concentration
Time frame: 480 minutes
4 secondary outcomes
Time to maximal insulin concentration
Time frame: 480 minutes
Time to 1/2 maximal insulin concentration after peak
Time frame: 480 minutes
Visual analog scale
Time frame: 30 minutes
AUC 0-30 and AUC 0-60
Time frame: 60 minutes
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 15 Mar 2013.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insulin LISPRO in people with Type 1 Diabetes, run by Biodel.
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 3 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 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Time to 1/2 maximal insulin concentration (time frame: 480 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 15 Mar 2013.