HypoglycemiaPhase 1NCT02403648
Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons
A Phase 1 study testing BIOD-961, Lilly Glucagon and Novo Glucagon in people with Hypoglycemia, run by Biodel.
Trial summary
BIOD-961 is a dry powder formulation of glucagon intended for use in a device that mixes (reconstitutes) the powder with liquid to make it easier for users to treat patients with severe hypoglycemia. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- BIOD-961, Lilly Glucagon and Novo Glucagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Mar 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index: 18.5-25.0 kg/m2 inclusive.
- Subject has provided informed consent and has signed and dated an informed consent form before any trial-related activities.
Who cannot join
- Type 1 or type 2 diabetes mellitus.
- History of pheochromocytoma, insulinoma, glucagonoma, or glycogen storage disease.
- History of regular alcohol consumption as defined by alcohol intake exceeding 7 drinks per week for females or 14 drinks per week for males, where 1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor.
- Significant cardiovascular (to include New York Heart Association (NYHA) Class III or- IV functional capacity or uncontrolled hypertension), respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease.
- Any significant cardiovascular event history, including angina, myocardial infarction, therapeutic coronary procedure (e.g, percutaneous transluminal coronary angioplasty, coronary bypass surgery), stroke, or transient ischemic attack.
- Females who are breast feeding, pregnant, or intending to become pregnant during the study.
About this study
Official title: Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Glucagon for Injection (Eli Lilly) and GlucaGen® (Novo Nordisk) Administered by Subcutaneous and Intramuscular Injection in Normal, Healthy Volunteers
BIOD-961 is a dry powder formulation of glucagon intended for use in a device that mixes (reconstitutes) the powder with liquid to make it easier for users to treat patients with severe hypoglycemia. The purpose of this study is to evaluate how much BIOD-961 absorbs into the bloodstream, how much it raises glucose concentrations (the intended effect) and compare to two glucagon products already on the market.
Read the detailed description
Subjects receive on separate days, in random order one of the following: 1 mg BIOD-961 intramuscularly (IM), 1 mg Lilly (IM), 1 mg Novo (IM), 1 mg BIOD-961 subcutaneously (SC), 1 mg Lilly (SC), and 1 mg Novo (SC).
- Conditions
- Hypoglycemia
- Being tested
- BIOD-961, Lilly Glucagon, Novo Glucagon
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOD-961Drug
BIOD-961 is a lyophilized glucagon formulation.
Lilly GlucagonDrug
Novo GlucagonDrug
| Study group | Role | What they receive |
|---|---|---|
| BIOD-961, 1 mg IM | Experimental | Intramuscular delivery of BIOD-961. Receives: Drug: BIOD-961 |
| Lilly Glucagon, 1 mg IM | Active comparator | Intramuscular delivery of Lilly glucagon. Receives: Drug: Lilly Glucagon |
| Novo Glucagon, 1 mg IM | Active comparator | Intramuscular delivery of Novo glucagon. Receives: Drug: Novo Glucagon |
| BIOD-961, 1 mg SC | Experimental | Subcutaneous delivery of BIOD-961, Receives: Drug: BIOD-961 |
| Lilly Glucagon, 1 mg SC | Active comparator | Subcutaneous delivery of Lilly glucagon. Receives: Drug: Lilly Glucagon |
| Novo Glucagon, 1 mg SC | Active comparator | Subcutaneous delivery of Novo glucagon. Receives: Drug: Novo Glucagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucagon maximal concentration and area under curve
Measured: 240 minutes post dose
Glucose maximal concentration and area under curve
Measured: 240 minutes after dose
Secondary outcomes (4)
Time to maximal glucagon concentration
Measured: 240 minutes after dose
Time to maximal glucose concentration
Measured: 240 minutes after dose
Maximal glucose excursion
Measured: 240 minutes after dose
Area under the glucose time curve from 0 to return to baseline after blood glucose peaked
Measured: 240 minutes after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 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.Alan Krasner, MD, Study director, Biodel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403648
- Sponsor's protocol ID
- 6-101
- Status last verified
- Jan 2016
- First submitted
- 26 Mar 2015
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Glucagon for Injection (Eli Lilly) and GlucaGen® (Novo Nordisk) Administered by Subcutaneous and Intramuscular Injection in Normal, Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02403648
- Acronym / sponsor ID
- 6-101
- Conditions
- Hypoglycemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- BiodelIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (actual)
- First posted
- 31 Mar 2015 (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.
BIOD-961 is a dry powder formulation of glucagon intended for use in a device that mixes (reconstitutes) the powder with liquid to make it easier for users to treat patients with severe hypoglycemia. The purpose of this study is to evaluate how much BIOD-961 absorbs into the bloodstream, how much it raises glucose concentrations (the intended effect) and compare to two glucagon products already on the market.
Detailed description
Subjects receive on separate days, in random order one of the following: 1 mg BIOD-961 intramuscularly (IM), 1 mg Lilly (IM), 1 mg Novo (IM), 1 mg BIOD-961 subcutaneously (SC), 1 mg Lilly (SC), and 1 mg Novo (SC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BIOD-961, 1 mg IM | Experimental | Drug: BIOD-961Intramuscular delivery of BIOD-961. |
| Lilly Glucagon, 1 mg IM | Active comparator | Drug: Lilly GlucagonIntramuscular delivery of Lilly glucagon. |
| Novo Glucagon, 1 mg IM | Active comparator | Drug: Novo GlucagonIntramuscular delivery of Novo glucagon. |
| BIOD-961, 1 mg SC | Experimental | Drug: BIOD-961Subcutaneous delivery of BIOD-961, |
| Lilly Glucagon, 1 mg SC | Active comparator | Drug: Lilly GlucagonSubcutaneous delivery of Lilly glucagon. |
| Novo Glucagon, 1 mg SC | Active comparator | Drug: Novo GlucagonSubcutaneous delivery of Novo glucagon. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index: 18.5-25.0 kg/m2 inclusive.
- Subject has provided informed consent and has signed and dated an informed consent form before any trial-related activities.
Key exclusion criteria (6 listed)
- Type 1 or type 2 diabetes mellitus.
- History of pheochromocytoma, insulinoma, glucagonoma, or glycogen storage disease.
- History of regular alcohol consumption as defined by alcohol intake exceeding 7 drinks per week for females or 14 drinks per week for males, where 1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor.
- Significant cardiovascular (to include New York Heart Association (NYHA) Class III or- IV functional capacity or uncontrolled hypertension), respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease.
- Any significant cardiovascular event history, including angina, myocardial infarction, therapeutic coronary procedure (e.g, percutaneous transluminal coronary angioplasty, coronary bypass surgery), stroke, or transient ischemic attack.
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-961BIOD-961 is a lyophilized glucagon formulation. | Drug | BIOD-961, 1 mg IM, BIOD-961, 1 mg SC |
| Lilly Glucagon | Drug | Lilly Glucagon, 1 mg IM, Lilly Glucagon, 1 mg SC |
| Novo Glucagon | Drug | Novo Glucagon, 1 mg IM, Novo Glucagon, 1 mg SC |
Primary outcome
Glucagon maximal concentration and area under curve
Time frame: 240 minutes post dose
Glucose maximal concentration and area under curve
Time frame: 240 minutes after dose
4 secondary outcomes
Time to maximal glucagon concentration
Time frame: 240 minutes after dose
Time to maximal glucose concentration
Time frame: 240 minutes after dose
Maximal glucose excursion
Time frame: 240 minutes after dose
Area under the glucose time curve from 0 to return to baseline after blood glucose peaked
Time frame: 240 minutes after dose
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 Jan 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.
Linda Morrow, MD principal investigator
Profil Institute for Clinical Research, Inc.
Alan Krasner, MD study director
Biodel
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIOD-961, Lilly Glucagon and Novo Glucagon in people with Hypoglycemia, 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 2 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 Jan 2016. 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?
Glucagon maximal concentration and area under curve (time frame: 240 minutes post dose). The study lists 2 primary outcomes in all. 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 Jan 2016.