Diabetes MellitusPhase 1/2NCT02324309
BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500 Post-Meal Glucose Control in Patients With Severe Insulin Resistance
A Phase 1/2 study testing BIOD-531, Humalog Mix 75/25 and Humulin R U-500 in people with Diabetes Mellitus, run by Biodel at 1 site in United States.
Trial summary
The study is designed to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500 in patients with diabetes and severe insulin resistance. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- BIOD-531, Humalog Mix 75/25 and Humulin R U-500
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Nov 2014
- Phase
- Phase 1/2
- 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
- BMI > 25 kg/m2
- Diabetes Mellitus using ≥ 150 units of insulin or insulin analog per day and/or ≥ 100 units of insulin or insulin analog at a single dosing session for at least 1 month prior to screening
- HbA1c < 10.0%
Who cannot join
- History of bariatric surgery
- Corticosteroid therapy
- Significant cardiovascular or other major organ disease
- Females who are breast feeding or pregnant
- A sexually active person not using adequate contraceptive methods
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 Single-blind Crossover Study of the Pharmacokinetic and Postprandial Glucose Dynamics of BIOD-531 Compared to Humulin® R U-500 and Humalog® Mix75/25™ in Subjects With Type 2 DM Who Are Treated With ≥ 150 Units of Insulin Per Day
The study is designed to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500 in patients with diabetes and severe insulin resistance.
- Conditions
- Diabetes Mellitus
- Being tested
- BIOD-531, Humalog Mix 75/25, Humulin R U-500
- 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-531Drug
Humalog Mix 75/25Drug
Humulin R U-500Drug
BIOD-531Drug
| Study group | Role | What they receive |
|---|---|---|
| BIOD-531 pre-meal | Experimental | Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner. Receives: Drug: BIOD-531 |
| Humalog Mix 75/25 pre-meal | Active comparator | Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner. Receives: Drug: Humalog Mix 75/25 |
| Humulin R U-500 pre-meal | Active comparator | Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner. Receives: Drug: Humulin R U-500 |
| BIOD-531 post-meal | Experimental | Subcutaneous injections of 1.2 U/kg 20 minutes after the start of a standardized breakfast and 0.8 U/kg 20 minutes after the start of a standardized dinner. Receives: Drug: BIOD-531 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-breakfast glucose exposure (AUC)
Measured: 0-330 minutes
Secondary outcomes (5)
Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)
Measured: 0-330 and 660-1020 minutes
Insulin exposure (AUC)
Measured: 0-1440 minutes
Maximal insulin concentration
Measured: 0-330 and 660-1020 minutes
Post-lunch and post-dinner glucose exposures (AUC)
Measured: 330-660 and 660-1020 minutes
Injection site toleration (VAS and severity scales)
Measured: 30 and 690 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2014
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biodel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurie Han-Conrad, MD, Principal investigator, Profil Institute for Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324309
- Sponsor's protocol ID
- 3-151
- Status last verified
- Jan 2016
- First submitted
- 17 Dec 2014
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind Crossover Study of the Pharmacokinetic and Postprandial Glucose Dynamics of BIOD-531 Compared to Humulin® R U-500 and Humalog® Mix75/25™ in Subjects With Type 2 DM Who Are Treated With ≥ 150 Units of Insulin Per Day
- ClinicalTrials.gov ID
- NCT02324309
- Acronym / sponsor ID
- 3-151
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- BiodelIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Nov 2014 (actual)
- First posted
- 24 Dec 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.
The study is designed to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500 in patients with diabetes and severe insulin resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BIOD-531 pre-meal | Experimental | Drug: BIOD-531Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner. |
| Humalog Mix 75/25 pre-meal | Active comparator | Drug: Humalog Mix 75/25Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner. |
| Humulin R U-500 pre-meal | Active comparator | Drug: Humulin R U-500Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner. |
| BIOD-531 post-meal | Experimental | Drug: BIOD-531Subcutaneous injections of 1.2 U/kg 20 minutes after the start of a standardized breakfast and 0.8 U/kg 20 minutes after the start of a standardized dinner. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI > 25 kg/m2
- Diabetes Mellitus using ≥ 150 units of insulin or insulin analog per day and/or ≥ 100 units of insulin or insulin analog at a single dosing session for at least 1 month prior to screening
- HbA1c < 10.0%
Key exclusion criteria (5 listed)
- History of bariatric surgery
- Corticosteroid therapy
- Significant cardiovascular or other major organ disease
- Females who are breast feeding or pregnant
- A sexually active person not using adequate contraceptive methods
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-531 | Drug | BIOD-531 pre-meal |
| Humalog Mix 75/25 | Drug | Humalog Mix 75/25 pre-meal |
| Humulin R U-500 | Drug | Humulin R U-500 pre-meal |
| BIOD-531 | Drug | BIOD-531 post-meal |
Primary outcome
Post-breakfast glucose exposure (AUC)
Time frame: 0-330 minutes
5 secondary outcomes
Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)
Time frame: 0-330 and 660-1020 minutes
Insulin exposure (AUC)
Time frame: 0-1440 minutes
Maximal insulin concentration
Time frame: 0-330 and 660-1020 minutes
Post-lunch and post-dinner glucose exposures (AUC)
Time frame: 330-660 and 660-1020 minutes
Injection site toleration (VAS and severity scales)
Time frame: 30 and 690 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 8 Feb 2016.
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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.
Laurie Han-Conrad, MD principal investigator
Profil Institute for Clinical Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BIOD-531, Humalog Mix 75/25 and Humulin R U-500 in people with Diabetes Mellitus, 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 3 inclusion and 5 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 8 Feb 2016. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Post-breakfast glucose exposure (AUC) (time frame: 0-330 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 8 Feb 2016.