Type 1 DiabetesPhase 1/2Pre-POINTNCT02620553
Primary Intervention With Mucosal Insulin
A Phase 1/2 study testing Human Insulin in people with Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
A dose with proven drug bioavailability to the immune system for use in a phase II/III primary T1DM (type 1 diabetes) vaccination trial (POINT study) in genetically at risk subjects. Study Design Randomized, placebo-controlled, double-blind/double-masked, multi-center, dose escalation primary intervention pilot study. Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Human Insulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jan 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 2 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 2 years to 7 years who:
- Have a multiplex first degree family history of T1DM (both parents, parent and sib, or two sibs);
- Type 1 diabetes susceptible HLA DR4-DQB1*0302 or DR4-DQB1*0304 haplotype and
- None of the following HLA DR or DQB1 alleles:
- DR 11
- DR 12
Show all 12Show fewer
- DQB1*0602
- DR7-DQB1*0303
- DR14-DQB1*0503 or
- Have a sibling with T1DM;
- Identical by descent for the HLA DR3/DR4-DQ8 genotype with their diabetic sibling;
- Islet autoantibody negative at time of recruitment.
Who cannot join
- Children with any kind of congenital or acquired chronic disease that potentially interfere with the study objectives.
- Prior or current participation in another intervention trial.
- Chronic oral steroid use and/or other chronic oral immunosuppressant
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
About this study
Official title: Primary Intervention With Mucosal Insulin for Prevention of Type 1 Diabetes in Infants at High Genetic Risk to Develop Diabetes POINT (Primary Oral Insulin Trial) A Dose Finding and Safety Study ( Pre-POINT )
A dose with proven drug bioavailability to the immune system for use in a phase II/III primary T1DM (type 1 diabetes) vaccination trial (POINT study) in genetically at risk subjects.
Study Design Randomized, placebo-controlled, double-blind/double-masked, multi-center, dose escalation primary intervention pilot study.
Accrual Objective 25 (3:2 randomization to active and control arms)
Read the detailed description
The objective of this study is to determine the feasibility, safety and bioavailability of oral insulin in children with high genetic risk for T1DM in a dose escalation primary intervention pilot study.
- Conditions
- Type 1 Diabetes
- Being tested
- Human Insulin, Oral Placebo
- Keywords
- Type 1 Diabetes, Diabetes, Autoimmune Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human InsulinDrug
Also called Oral Insulin
There is a study drug dose increase once during the study. The dose increase will occur 6 months after entering into the study. A total of 6 children will be included at each dose (3 children will not have received insulin prior to entering the study and 3 children will have received a lower dose of insulin for 6 months). Further dose increases or more frequent dose increases in individual children will not be performed during Pre-POINT. Escalation will occur in both treatment and placebo group so that participants and study investigators will remain blinded to treatment throughout the study. First dose (2.5 mg oral insulin/day) Second dose (7.5 mg oral insulin/day) Third dose (22.5 mg oral insulin/day) Fourth dose (67.5 mg oral insulin/day)
Oral PlaceboOther
Oral Placebo is given orally daily
| Study group | Role | What they receive |
|---|---|---|
| Human Insulin | Experimental | Oral Insulin at 2.5 mg, 7.5 mg, 22.5 mg, or 67.5 mg per day Receives: Drug: Human Insulin |
| Placebo | Placebo comparator | Oral Placebo Receives: Other: Oral Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Glucose Levels
Evaluation for hypoglycemia will be measured prior to administration of the insulin (baseline), then at 30, 60, and 120 minutes after administration of the insulin.
Measured: Day 1
Daily Evaluation of Blood Glucose Levels
Blood glucose will be measured 60 minutes after the administration of the Insulin.
Measured: Days 2 through 7
Evaluation of Blood Glucose Levels
After treatment day 7, Insulin will be administered and measured on a monthly basis.
Measured: Measured 60 minutes after oral insulin dosing, every day during each 4th week, as long as the subject is given oral insulin.
Secondary outcomes (2)
Change in Total IgE and IgE.
Allergy/intolerance to the study drug evaluated with total IgE and IgE antibodies to insulin at 2 weeks, 3 months, 6 months, then every 6 months thereafter, as well as monitored through self-reporting by families. Parents/guardians will be educated on and instructed to look out for possible allergic reactions to insulin.
Measured: 2 weeks, 3 months, 6 months
T-cell responses related to potential immune response to Insulin
T-cell responses e.g. antibody and cell mediated immune results will be evaluated the day of administration then at 15 days, 3 and 6 months, and every 6 months of treatment, and will be reported directly to the Data Coordinating Center.
Measured: Day 1, 15 days, 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startSep 2007
- Primary completionJun 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Dresden, Diabetes Research Institute, Munich, Germany., University of Bristol, Juvenile Diabetes Research Foundation, German Federal Ministry of Education and Research
- Responsible party
- Sponsor
- Investigators
- Ezio Bonifacio, PhD, Principal investigator, Medical Faculty Carl Gustav Carus, Dresden University of TechnologyGeorgeanna J Klingensmith, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620553
- Sponsor's protocol ID
- 05-1043
- Acronym
- Pre-POINT
- Status last verified
- Apr 2017
- First submitted
- 8 Jun 2015
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Bonifacio E, Ziegler AG, Klingensmith G, Schober E, Bingley PJ, Rottenkolber M, Theil A, Eugster A, Puff R, Peplow C, Buettner F, Lange K, Hasford J, Achenbach P; Pre-POINT Study Group. Effects of high-dose oral insulin on immune responses in children at high risk for type 1 diabetes: the Pre-POINT randomized clinical trial. JAMA. 2015 Apr 21;313(15):1541-9. doi: 10.1001/jama.2015.2928.
PubMed 25898052
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Intervention With Mucosal Insulin for Prevention of Type 1 Diabetes in Infants at High Genetic Risk to Develop Diabetes POINT (Primary Oral Insulin Trial) A Dose Finding and Safety Study ( Pre-POINT )
- ClinicalTrials.gov ID
- NCT02620553
- Acronym / sponsor ID
- Pre-POINT / 05-1043
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Diabetes, Autoimmune Diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University Hospital Dresden, Diabetes Research Institute, Munich, Germany., University of Bristol, Juvenile Diabetes Research Foundation, German Federal Ministry of Education and Research
- Study start
- Sep 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 3 Dec 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.
A dose with proven drug bioavailability to the immune system for use in a phase II/III primary T1DM (type 1 diabetes) vaccination trial (POINT study) in genetically at risk subjects.
Study Design Randomized, placebo-controlled, double-blind/double-masked, multi-center, dose escalation primary intervention pilot study.
Accrual Objective 25 (3:2 randomization to active and control arms)
Detailed description
The objective of this study is to determine the feasibility, safety and bioavailability of oral insulin in children with high genetic risk for T1DM in a dose escalation primary intervention pilot study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Insulin | Experimental | Drug: Human InsulinOral Insulin at 2.5 mg, 7.5 mg, 22.5 mg, or 67.5 mg per day |
| Placebo | Placebo comparator | Other: Oral PlaceboOral Placebo |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Children aged 2 years to 7 years who:
- Islet autoantibody negative at time of recruitment.
Key exclusion criteria (3 listed)
- Children with any kind of congenital or acquired chronic disease that potentially interfere with the study objectives.
- Prior or current participation in another intervention trial.
- Chronic oral steroid use and/or other chronic oral immunosuppressant
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 |
|---|---|---|
| Human InsulinAlso: Oral InsulinThere is a study drug dose increase once during the study. The dose increase will occur 6 months after entering into the study. A total of 6 children will be included at each dose (3 children will not have received insulin prior to entering the study and 3 children will have received a lower dose of insulin for 6 months). Further dose increases or more frequent dose increases in individual children will not be performed during Pre-POINT. Escalation will occur in both treatment and placebo group so that participants and study investigators will remain blinded to treatment throughout the study. First dose (2.5 mg oral insulin/day) Second dose (7.5 mg oral insulin/day) Third dose (22.5 mg oral insulin/day) Fourth dose (67.5 mg oral insulin/day) | Drug | Human Insulin |
| Oral PlaceboOral Placebo is given orally daily | Other | Placebo |
Primary outcome
Change in Blood Glucose Levels
Time frame: Day 1
Evaluation for hypoglycemia will be measured prior to administration of the insulin (baseline), then at 30, 60, and 120 minutes after administration of the insulin.
Daily Evaluation of Blood Glucose Levels
Time frame: Days 2 through 7
Blood glucose will be measured 60 minutes after the administration of the Insulin.
Evaluation of Blood Glucose Levels
Time frame: Measured 60 minutes after oral insulin dosing, every day during each 4th week, as long as the subject is given oral insulin.
After treatment day 7, Insulin will be administered and measured on a monthly basis.
2 secondary outcomes
Change in Total IgE and IgE.
Time frame: 2 weeks, 3 months, 6 months
T-cell responses related to potential immune response to Insulin
Time frame: Day 1, 15 days, 3 and 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 20 Apr 2017.
- Results publication: PubMed 25898052Bonifacio E, Ziegler AG, Klingensmith G, Schober E, Bingley PJ, Rottenkolber M, Theil A, Eugster A, Puff R, Peplow C, Buettner F, Lange K, Hasford J, Achenbach P; Pre-POINT Study Group. Effects of high-dose oral insulin on immune responses in children at high risk for type 1 diabetes: the Pre-POINT randomized clinical trial. JAMA. 2015 Apr 21;313(15):1541-9. doi: 10.1001/jama.2015.2928.
- Pre-POINTLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Ezio Bonifacio, PhD principal investigator
Medical Faculty Carl Gustav Carus, Dresden University of Technology
Georgeanna J Klingensmith, MD principal investigator
University of Colorado, Denver
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 Human Insulin in people with Type 1 Diabetes, run by University of Colorado, Denver 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 12 inclusion and 3 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 20 Apr 2017. 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. 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 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?
Change in Blood Glucose Levels (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02620553, which also lists 1 linked publication.
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 20 Apr 2017.