New Onset Type-1 DiabetesPhase 2NCT02005848
Phase II Study to Evaluate the Efficacy and Safety of Glassia® in Type-1 Diabetes
A Phase 2 study testing Alpha-1 Antitrypsin in people with New Onset Type-1 Diabetes, run by Kamada, Ltd. at 4 sites in Israel.
Trial summary
A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Study Evaluating the Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in the Treatment of New Onset Type-1 Diabetes. Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- New Onset Type-1 Diabetes
- What is being tested?
- Alpha-1 Antitrypsin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 4 sitesIsrael
- Study dates
- Apr 2014to Feb 2017
- Phase
- Phase 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 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Main Inclusion Criteria:
- Subject (or parent/guardian) willing and able to sign an informed consent
- Age 8-25 (inclusive) years
- Recently diagnosed with T1DM
- Basal C-peptide ≥ 0.2 pmol/mL
- Positive for at least one diabetes-related autoantibody
- Ability and consent to comply with completion of patient diary
- No significant abnormalities in serum hematology, serum chemistry
- No significant abnormalities in urinalysis
- No significant abnormalities in ECG
- For women of child bearing potential, non-pregnant, non-lactating female patients
Main Exclusion Criteria:
- IgA deficient subjects
- Subjects who have received an active/ live virus vaccine within 4 weeks of the screening date
- Subjects who have received treatment with corticosteroid medication within 2 months prior to screening or any immunosuppressant or cytostatic agent within 6 months prior to screening
- Individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to plasma products
- Clinically significant intercurrent illnesses
- Pregnant or lactating women
- Current use of any medication known to influence glucose tolerance
- Current or prior (within the last 60 days prior to screening visit) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors or amylin.
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Soroka Medical Center
Beersheba
Rambam Medical Center
Haifa
Schneider Children's Medical Center
Pethach Tikva
Assaf Harofe Medical Center
Tsrifin
About this study
Official title: Phase II Study to Evaluate the Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in the Treatment of New Onset Type-1 Diabetes
A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Study Evaluating the Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in the Treatment of New Onset Type-1 Diabetes.
The study objectives are:
- To assess the efficacy of intravenous AAT in treatment of new onset Type 1 Diabetes
- To assess the safety and tolerability of intravenous AAT in new onset Type 1 Diabetes pediatric and young adult population.
- Conditions
- New Onset Type-1 Diabetes
- Being tested
- Alpha-1 Antitrypsin, Placebo
- Keywords
- Type-1 Diabetes, T1D, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-1 AntitrypsinBiological
Also called Humman Alpha-1 Antitrypsin, Alpha-1 Proteinase Inhibitor, API, AAT
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Alpha1 Antitrypsin (Glassia) | Experimental | 60 mg/kg body weight Receives: Biological: Alpha-1 Antitrypsin |
| Alpha-1 Antitrypsin (Glassia) | Experimental | 120 mg/kg body weight Receives: Biological: Alpha-1 Antitrypsin |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta cell function
Beta cell function (measured by C peptide)
Measured: 12 months from baseline
Secondary outcomes (5)
Glycemic control
Glycemic control expressed in HbA1c level
Measured: 12 months from baseline
Beta cell function
Measured: 12 months from baseline
Insulin dose
Measured: 12 months from baseline
Hypoglycemic episodes
Measured: 12 months from baseline
Safety parameters
Adverse events, vital signs, physical examination
Measured: 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startApr 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New Onset Type-1 DiabetesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kamada, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005848
- Sponsor's protocol ID
- Kamada-AAT(IV)-011
- Status last verified
- Oct 2018
- First submitted
- 27 Nov 2013
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate the Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in the Treatment of New Onset Type-1 Diabetes
- ClinicalTrials.gov ID
- NCT02005848
- Acronym / sponsor ID
- Kamada-AAT(IV)-011
- Conditions
- New Onset Type-1 Diabetes
- Keywords
- Type-1 Diabetes, T1D, Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kamada, Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 9 Dec 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.
A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Study Evaluating the Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in the Treatment of New Onset Type-1 Diabetes.
The study objectives are:
- To assess the efficacy of intravenous AAT in treatment of new onset Type 1 Diabetes
- To assess the safety and tolerability of intravenous AAT in new onset Type 1 Diabetes pediatric and young adult population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alpha1 Antitrypsin (Glassia) | Experimental | Biological: Alpha-1 Antitrypsin60 mg/kg body weight |
| Alpha-1 Antitrypsin (Glassia) | Experimental | Biological: Alpha-1 Antitrypsin120 mg/kg body weight |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Alpha-1 AntitrypsinAlso: Humman Alpha-1 Antitrypsin, Alpha-1 Proteinase Inhibitor, API, AAT | Biological | Alpha-1 Antitrypsin (Glassia), Alpha1 Antitrypsin (Glassia) |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Beta cell function
Time frame: 12 months from baseline
Beta cell function (measured by C peptide)
5 secondary outcomes
Glycemic control
Time frame: 12 months from baseline
Beta cell function
Time frame: 12 months from baseline
Insulin dose
Time frame: 12 months from baseline
Hypoglycemic episodes
Time frame: 12 months from baseline
Safety parameters
Time frame: 12 months from baseline
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 11 Oct 2018.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alpha-1 Antitrypsin in people with New Onset Type-1 Diabetes, run by Kamada, Ltd. at 4 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. 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. Some participants in this study may receive a placebo. 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 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?
Beta cell function (time frame: 12 months from baseline). 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 11 Oct 2018.