Diabetes Mellitus Type 1Phase 1NCT01334151
Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes
A Phase 1 study testing Insulin LISPRO and recombinant human insulin in people with Diabetes Mellitus Type 1, run by Biodel at 1 site in United States.
Trial summary
The primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Diabetes Mellitus Type 1
- What is being tested?
- Insulin LISPRO and recombinant human insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Aug 2011
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must present with the following:
- Body Mass Index: ≥ 18 - ≤ 28 kg/m2
- Diagnosed with type 1 diabetes mellitus for at least 1 year
- Insulin antibody less than or equal to 10 μU/mL at screening
Who cannot join
- Subjects presenting with any of the following will not be included in the study:
- 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 screening visit
- Regular smoking as assessed clinically by the Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Profil Institute for Clinical Research, Inc. (PICR)
Chula Vista, California, 91911
About this study
Official title: A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration
The primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®.
Read the detailed description
The secondary objectives of this study are to assess other pharmacokinetic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, to assess other pharmacodynamic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-105 and BIOD-107 compared to Humalog®.
- Conditions
- Diabetes Mellitus Type 1
- Being tested
- Insulin LISPRO, recombinant human 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.
Insulin LISPRODrug
Single doses of: 0.15 U/kg
recombinant human insulinDrug
Single doses of: 0.15 U/kg
| Study group | Role | What they receive |
|---|---|---|
| Humalog® | Active comparator | Humalog®, administered subcutaneously on 1 occasion Receives: Drug: Insulin LISPRO |
| BIOD- 105 | Experimental | BIOD- 105 administered subcutaneously on 1 occasion Receives: Drug: recombinant human insulin |
| BIOD-107 | Experimental | BIOD-107 administered subcutaneously on 1 occasion Receives: Drug: recombinant human insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of absorption
The speed of absorption will be assessed by the time to reach 50% of maximum insulin concentration (TINS-50%-early, time before CINS max) and the onset of action will be assessed by the time to reach 50% of the maximum glucose infusion rate (TGIR-50%- early).
Measured: 480 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2011
- Study completionAug 2011
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biodel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda Morrow, MD, Principal investigator, Profil Institute for Clinical Research, Inc. (PICR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334151
- Sponsor's protocol ID
- VIAject 039J
- Status last verified
- Jul 2013
- First submitted
- 11 Apr 2011
- Last updated
- 26 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration
- ClinicalTrials.gov ID
- NCT01334151
- Acronym / sponsor ID
- VIAject 039J
- Conditions
- Diabetes Mellitus Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- BiodelIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Apr 2011 (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 primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®.
Detailed description
The secondary objectives of this study are to assess other pharmacokinetic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, to assess other pharmacodynamic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-105 and BIOD-107 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 |
|---|---|---|
| Humalog® | Active comparator | Drug: Insulin LISPROHumalog®, administered subcutaneously on 1 occasion |
| BIOD- 105 | Experimental | Drug: recombinant human insulinBIOD- 105 administered subcutaneously on 1 occasion |
| BIOD-107 | Experimental | Drug: recombinant human insulinBIOD-107 administered subcutaneously on 1 occasion |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body Mass Index: ≥ 18 - ≤ 28 kg/m2
- Diagnosed with type 1 diabetes mellitus for at least 1 year
- Insulin antibody less than or equal to 10 μU/mL at screening
Key exclusion criteria (7 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 screening visit
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 LISPROSingle doses of: 0.15 U/kg | Drug | Humalog® |
| recombinant human insulinSingle doses of: 0.15 U/kg | Drug | BIOD- 105, BIOD-107 |
Primary outcome
Speed of absorption
Time frame: 480 minutes
The speed of absorption will be assessed by the time to reach 50% of maximum insulin concentration (TINS-50%-early, time before CINS max) and the onset of action will be assessed by the time to reach 50% of the maximum glucose infusion rate (TGIR-50%- early).
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 26 Jul 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.
Linda Morrow, MD principal investigator
Profil Institute for Clinical Research, Inc. (PICR)
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 LISPRO and recombinant human insulin in people with Diabetes Mellitus Type 1, run by Biodel 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 4 inclusion and 7 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 26 Jul 2013. 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?
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?
Speed of absorption (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 26 Jul 2013.