Type 2 Diabetes MellitusPhase 1/2NCT02212951
Comparison of Postprandial Glucose Control Associated With BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500
A Phase 1/2 study testing BIOD-531, Humalog Mix 75/25 and Humulin R U-500 in people with Type 2 Diabetes Mellitus, run by Biodel at 1 site in United States.
Trial summary
The study is 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 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 Jul 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
- Age 18-65
- BMI > 25 kg/m2
- Type 2 Diabetes Mellitus
- HbA1c < 10.0%
- Subject uses 50-200 units of insulin/day
Who cannot join
- Type 1 Diabetes Mellitus
- 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
Chula Vista, California
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 Mix 75/25 in Subjects With Type 2 Diabetes Mellitus Who Are Treated With 50-200 Units of Insulin Per Day
The study is 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- BIOD-531, Humalog Mix 75/25, Humulin R U-500
- Medical subject headings
- Diabetes Mellitus, Type 2
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
| Study group | Role | What they receive |
|---|---|---|
| BIOD-531 pre-meal | Experimental | Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast Receives: Drug: BIOD-531 |
| Humalog Mix 75/25 pre-meal | Active comparator | Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast Receives: Drug: Humalog Mix 75/25 |
| Humulin R U-500 | Active comparator | Subcutaneous injection of 0.6 U/kg immediately before the start of a standardized breakfast Receives: Drug: Humulin R U-500 |
| BIOD-531 post-meal | Experimental | Subcutaneous injection of 0.6 U/kg 20 minutes after the start of the standardized breakfast Receives: Drug: BIOD-531 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-standardized meal glucose exposure (AUC)
Measured: 0-120 minutes after meal
Secondary outcomes (7)
Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)
Measured: 0-720 minutes
Insulin exposure (AUC)
Measured: Various time frames over 720 minutes
Maximal insulin concentration
Measured: 0-720 minutes
Post breakfast and post-lunch glucose exposure (AUC)
Measured: Various times frames over 720 minutes
Post-breakfast and post-lunch maximal glucose concentrations
Measured: 0-720 minutes
Injection site toleration (VAS and severity scales)
Measured: 30 minutes post injection
Draize injection site erythema and edema scoring
Measured: 0-720 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212951
- Sponsor's protocol ID
- 3-152
- Status last verified
- Jan 2016
- First submitted
- 7 Aug 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 Mix 75/25 in Subjects With Type 2 Diabetes Mellitus Who Are Treated With 50-200 Units of Insulin Per Day
- ClinicalTrials.gov ID
- NCT02212951
- Acronym / sponsor ID
- 3-152
- Conditions
- Type 2 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
- Jul 2014 (actual)
- First posted
- 11 Aug 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 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.
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 injection of 0.6 U/kg immediately before the start of the standardized breakfast |
| Humalog Mix 75/25 pre-meal | Active comparator | Drug: Humalog Mix 75/25Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast |
| Humulin R U-500 | Active comparator | Drug: Humulin R U-500Subcutaneous injection of 0.6 U/kg immediately before the start of a standardized breakfast |
| BIOD-531 post-meal | Experimental | Drug: BIOD-531Subcutaneous injection of 0.6 U/kg 20 minutes after the start of the standardized breakfast |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65
- BMI > 25 kg/m2
- Type 2 Diabetes Mellitus
- HbA1c < 10.0%
- Subject uses 50-200 units of insulin/day
Key exclusion criteria (6 listed)
- Type 1 Diabetes Mellitus
- History of bariatric surgery
- Corticosteroid therapy
- Significant cardiovascular or other major organ disease
- Females who are breast feeding or pregnant
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 post-meal, BIOD-531 pre-meal |
| Humalog Mix 75/25 | Drug | Humalog Mix 75/25 pre-meal |
| Humulin R U-500 | Drug | Humulin R U-500 |
Primary outcome
Post-standardized meal glucose exposure (AUC)
Time frame: 0-120 minutes after meal
7 secondary outcomes
Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)
Time frame: 0-720 minutes
Insulin exposure (AUC)
Time frame: Various time frames over 720 minutes
Maximal insulin concentration
Time frame: 0-720 minutes
Post breakfast and post-lunch glucose exposure (AUC)
Time frame: Various times frames over 720 minutes
Post-breakfast and post-lunch maximal glucose concentrations
Time frame: 0-720 minutes
Injection site toleration (VAS and severity scales)
Time frame: 30 minutes post injection
Draize injection site erythema and edema scoring
Time frame: 0-720 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Type 2 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 5 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 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-standardized meal glucose exposure (AUC) (time frame: 0-120 minutes after meal). 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; AzTrials last refreshed its copy on 6 Nov 2026.