Type 1 DiabetesPhase 1NCT00662519
Neulasta in Type 1 Diabetes
A Phase 1 study testing Neulasta (Pegylated), Mixed Meal Tolerance Test (MMTT) and Blood test in people with Type 1 Diabetes, run by University of Florida at 1 site in United States.
Trial summary
The primary purpose of this study is to find out if giving a 12 week course of Neulasta (Pegylated granulocyte colony stimulating factor (GCSF)) to people with type 1 diabetes (T1D) is safe. Read more about this study
- Who is it for?
- Ages 12 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Neulasta (Pegylated), Mixed Meal Tolerance Test (MMTT) and Blood test
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Mar 2014
- 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 12 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Must be > 12 years old and have a confirmed diagnosis of "recent onset T1D" as defined by:
- T1D for < 6 months,
- Stimulated C-peptide ≥ 0.2 pmol/ml
- Presence of at least one diabetes-related autoantibody (e.g., GAD, IA-2, IAA, ICA)
- Normal screening values for CBC
- Willing to comply with intensive diabetes management
- No history of allergy to GCSF
- Females having reproductive potential must be willing to avoid pregnancy and have a negative pregnancy test
Who cannot join
- Known hypersensitivity to E.Coli-derived proteins, pegfilgrastim, Filgrastim, or any other component of the product
- Chronic use of steroids or other immunosuppressive agents
- Active infection
- Inability to maintain intensive diabetes management
- Pregnancy
- History of malignancy
- Currently participating in another type 1 diabetes treatment study.
- Use of non-insulin pharmaceuticals that affect glycemic control
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Course of Pegylated GCSF (Neulasta®) as Immunomodulatory Therapy for Type 1 Diabetes
The primary purpose of this study is to find out if giving a 12 week course of Neulasta (Pegylated granulocyte colony stimulating factor (GCSF)) to people with type 1 diabetes (T1D) is safe. The secondary purpose of this research study is to determin if giving GCSF to patients with T1D changes the immune system or preserves insulin production.
Read the detailed description
As a participant in this study the following will happen:
Blood test, Mixed meal Tolerance Test (MMT) to find out how much C-peptide is being produced, Human Leukocyte Antigen (HLA) test, Hemoglobin A1C (HbA1c) test for overall blood sugar control, and randomized to either receive the 12 week course of Neulasta (Pegylated granulocyte colony stimulating factor (GCSF)) or a placebo (no medication).
- Conditions
- Type 1 Diabetes
- Being tested
- Neulasta (Pegylated), Placebo, Mixed Meal Tolerance Test (MMTT), Blood test, DNA Test
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neulasta (Pegylated)Drug
Also called Pegylated granulocyte colony stimulating factor (GCSF)
Subjects will receive 6mg/dose given every 2 weeks for 12 weeks. Subjects less than 45kg will receive 100mcg/kg/dose every 2 weeks for 12 weeks.
PlaceboDrug
Also called Saline
Placebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner. 6mg/dose given every 2 weeks for 12 weeks. Subjects less than 45kg will receive 100mcg/kg/dose every 2 weeks for 12 weeks.
Mixed Meal Tolerance Test (MMTT)Dietary supplement
This is a 2 hour test to find out how much C-peptide is being produced. C-peptide is used to measure the insulin being made by the cells of the pancreas. Both groups will have this test performed.
Blood testOther
Also called Hemoglobin A1C (HbA1c)
HbA1c is a blood test that measures the average blood sugar control and will be performed in both groups.
DNA TestOther
Also called Human Leukocyte Antigen (HLA)
The HLA test looks at the different chromosomes (DNA) for diabetes and will be performed in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Neulasta | Experimental | Subjects will receive Neulasta subcutaneously every 2 weeks for 12 weeks (6 doses). In addition, the following test will be done: Mixed Meal Tolerance Test (MMTT), Hemoglobin A1C (HbA1c) blood test, and Human Leukocyte Antigen (HLA) DNA Test. Receives: Drug: Neulasta (Pegylated); Dietary Supplement: Mixed Meal Tolerance Test (MMTT); Other: Blood test; Other: DNA Test |
| Placebo | Placebo comparator | Placebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner. In addition, the following test will be done: Mixed Meal Tolerance Test (MMTT), Hemoglobin A1C (HbA1c) blood test, and Human Leukocyte Antigen (HLA) DNA Test. Receives: Drug: Placebo; Dietary Supplement: Mixed Meal Tolerance Test (MMTT); Other: Blood test; Other: DNA Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve C-peptide Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks.
The target population distribution of change in the Area Under the Curve in residual beta cell function (C-peptide levels) is the same for treatment and placebo.
Measured: Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks.
Number of participants with adverse events
Measured: 96 Weeks
Secondary outcomes (2)
Hemoglobin A1c (HbA1c) levels have the same target distribution for treatment and placebo
Measured: 96 weeks
Increase T regulatory cells (Treg) from the bone marrow
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Michael J Haller, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662519
- Sponsor's protocol ID
- UF IRB 280-2006
- Other IDs
- JDRF 11-2007-825, 1R21DK078863-01A1, GCRC 683
- Status last verified
- Apr 2015
- First submitted
- 16 Apr 2008
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Course of Pegylated GCSF (Neulasta®) as Immunomodulatory Therapy for Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00662519
- Acronym / sponsor ID
- UF IRB 280-2006
- Conditions
- Type 1 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 21 Apr 2008 (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 primary purpose of this study is to find out if giving a 12 week course of Neulasta (Pegylated granulocyte colony stimulating factor (GCSF)) to people with type 1 diabetes (T1D) is safe. The secondary purpose of this research study is to determin if giving GCSF to patients with T1D changes the immune system or preserves insulin production.
Detailed description
As a participant in this study the following will happen:
Blood test, Mixed meal Tolerance Test (MMT) to find out how much C-peptide is being produced, Human Leukocyte Antigen (HLA) test, Hemoglobin A1C (HbA1c) test for overall blood sugar control, and randomized to either receive the 12 week course of Neulasta (Pegylated granulocyte colony stimulating factor (GCSF)) or a placebo (no medication).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neulasta | Experimental | Drug: Neulasta (Pegylated), Dietary Supplement: Mixed Meal Tolerance Test (MMTT), Other: Blood test, Other: DNA TestSubjects will receive Neulasta subcutaneously every 2 weeks for 12 weeks (6 doses). In addition, the following test will be done: Mixed Meal Tolerance Test (MMTT), Hemoglobin A1C (HbA1c) blood test, and Human Leukocyte Antigen (HLA) DNA Test. |
| Placebo | Placebo comparator | Drug: Placebo, Dietary Supplement: Mixed Meal Tolerance Test (MMTT), Other: Blood test, Other: DNA TestPlacebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner. In addition, the following test will be done: Mixed Meal Tolerance Test (MMTT), Hemoglobin A1C (HbA1c) blood test, and Human Leukocyte Antigen (HLA) DNA Test. |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Must be > 12 years old and have a confirmed diagnosis of "recent onset T1D" as defined by:
- T1D for < 6 months,
- Stimulated C-peptide ≥ 0.2 pmol/ml
- Presence of at least one diabetes-related autoantibody (e.g., GAD, IA-2, IAA, ICA)
- Normal screening values for CBC
Key exclusion criteria (8 listed)
- Known hypersensitivity to E.Coli-derived proteins, pegfilgrastim, Filgrastim, or any other component of the product
- Chronic use of steroids or other immunosuppressive agents
- Active infection
- Inability to maintain intensive diabetes management
- Pregnancy
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 |
|---|---|---|
| Neulasta (Pegylated)Also: Pegylated granulocyte colony stimulating factor (GCSF)Subjects will receive 6mg/dose given every 2 weeks for 12 weeks. Subjects less than 45kg will receive 100mcg/kg/dose every 2 weeks for 12 weeks. | Drug | Neulasta |
| PlaceboAlso: SalinePlacebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner. 6mg/dose given every 2 weeks for 12 weeks. Subjects less than 45kg will receive 100mcg/kg/dose every 2 weeks for 12 weeks. | Drug | Placebo |
| Mixed Meal Tolerance Test (MMTT)This is a 2 hour test to find out how much C-peptide is being produced. C-peptide is used to measure the insulin being made by the cells of the pancreas. Both groups will have this test performed. | Dietary supplement | Neulasta, Placebo |
| Blood testAlso: Hemoglobin A1C (HbA1c)HbA1c is a blood test that measures the average blood sugar control and will be performed in both groups. | Other | Neulasta, Placebo |
| DNA TestAlso: Human Leukocyte Antigen (HLA)The HLA test looks at the different chromosomes (DNA) for diabetes and will be performed in both groups. | Other | Neulasta, Placebo |
Primary outcome
Area Under the Curve C-peptide Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks.
Time frame: Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks.
The target population distribution of change in the Area Under the Curve in residual beta cell function (C-peptide levels) is the same for treatment and placebo.
Number of participants with adverse events
Time frame: 96 Weeks
2 secondary outcomes
Hemoglobin A1c (HbA1c) levels have the same target distribution for treatment and placebo
Time frame: 96 weeks
Increase T regulatory cells (Treg) from the bone marrow
Time frame: 12 weeks
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 9 Apr 2015.
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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.
Michael J Haller, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neulasta (Pegylated), Mixed Meal Tolerance Test (MMTT) and Blood test in people with Type 1 Diabetes, run by University of Florida 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 8 inclusion and 8 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 9 Apr 2015. 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 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?
Area Under the Curve C-peptide Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks. (time frame: Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks.). 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 9 Apr 2015.