Diabetes MellitusPhase 1NCT01908894
Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Injection Site Toleration
A Phase 1 study testing BIOD-123, BIOD-125 and Humalog in people with Diabetes Mellitus, run by Biodel.
Trial summary
The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- BIOD-123, BIOD-125 and Humalog
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Mar 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 - ≤70 years
- BMI: ≥18 - ≤30 kg/m2
- Diagnosed with type 1 diabetes mellitus for at least 1 year
- Insulin antibody ≤10 μU/mL at screening
Who cannot join
- Type 2 diabetes mellitus
- History of >2 severe hypoglycemic events within the 3 months prior to screening
- Serum C-peptide >1.0 ng/mL
- Hemoglobin A1c (HbA1c) >10.0%
- Females who were breast feeding, pregnant, or intending to become pregnant during the study
- A sexually active person who was not using adequate contraceptive methods
- Positive serology for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
- Abnormal ECG, safety lab, or physical examination results that were deemed clinically significant by the investigator
About this study
Official title: A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration
The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.
Read the detailed description
The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.
The secondary objectives are to assess other pharmacokinetic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, to assess pharmacodynamic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-123 and BIOD-125 compared to Humalog®
- Conditions
- Diabetes Mellitus
- Being tested
- BIOD-123, BIOD-125, Humalog
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOD-123Drug
BIOD-125Drug
HumalogDrug
| Study group | Role | What they receive |
|---|---|---|
| BIOD-123 | Experimental | SC administration of 0.20 U/kg Receives: Drug: BIOD-123 |
| BIOD-125 | Experimental | SC administration of 0.20 U/kg Receives: Drug: BIOD-125 |
| Humalog | Active comparator | SC administration of 0.20 U/kg Receives: Drug: Humalog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of absorption (TINS-50%-early) of BIOD-123 and BIOD-125 versus Humalog.
Subjects were to receive study drug at 3 separate dosing visits separated by 3-28 days. The estimated duration of study participation for 1 subject was approximately 12 weeks. The estimated duration of the study was approximately 6 months.
Measured: 0-30, 0-60, 0-90, 0-480, and 120-480 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startFeb 2012
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 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
- NCT01908894
- Sponsor's protocol ID
- 3-101
- Status last verified
- Jul 2013
- First submitted
- 24 Jul 2013
- Last updated
- 26 Jul 2013
- Results posted
- 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-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration
- ClinicalTrials.gov ID
- NCT01908894
- Acronym / sponsor ID
- 3-101
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- BiodelIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 26 Jul 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.
The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.
Detailed description
The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.
The secondary objectives are to assess other pharmacokinetic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, to assess pharmacodynamic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-123 and BIOD-125 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-123 | Experimental | Drug: BIOD-123SC administration of 0.20 U/kg |
| BIOD-125 | Experimental | Drug: BIOD-125SC administration of 0.20 U/kg |
| Humalog | Active comparator | Drug: HumalogSC administration of 0.20 U/kg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: ≥18 - ≤70 years
- BMI: ≥18 - ≤30 kg/m2
- Diagnosed with type 1 diabetes mellitus for at least 1 year
- Insulin antibody ≤10 μU/mL at screening
Key exclusion criteria (8 listed)
- Type 2 diabetes mellitus
- History of >2 severe hypoglycemic events within the 3 months prior to screening
- Serum C-peptide >1.0 ng/mL
- Hemoglobin A1c (HbA1c) >10.0%
- Females who were breast feeding, pregnant, or intending to become pregnant during the study
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 |
|---|---|---|
| BIOD-123 | Drug | BIOD-123 |
| BIOD-125 | Drug | BIOD-125 |
| Humalog | Drug | Humalog |
Primary outcome
Speed of absorption (TINS-50%-early) of BIOD-123 and BIOD-125 versus Humalog.
Time frame: 0-30, 0-60, 0-90, 0-480, and 120-480 minutes
Subjects were to receive study drug at 3 separate dosing visits separated by 3-28 days. The estimated duration of study participation for 1 subject was approximately 12 weeks. The estimated duration of the study was approximately 6 months.
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.
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 BIOD-123, BIOD-125 and Humalog in people with Diabetes Mellitus, 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 4 inclusion and 8 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.
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 (TINS-50%-early) of BIOD-123 and BIOD-125 versus Humalog. (time frame: 0-30, 0-60, 0-90, 0-480, and 120-480 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.