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Type 1 DiabetesPhase 1/2PARADIGMNCT03977662

Pancreatic Islets and Parathyroid Gland Co-transplantation for Treatment of Type 1 Diabetes

A Phase 1/2 study testing Co-transplantation of PTG with pancreatic islets in people with Type 1 Diabetes, run by Peter Stock at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective is to test the hypothesis that co-transplantation of allogeneic PTG with adult pancreatic islets (derived from same deceased donor) in the IM site in people with Type 1 diabetes with functioning kidney and/or liver transplants is safe, allows islet engraftment, and leads to insulin independence. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
Co-transplantation of PTG with pancreatic islets
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
1 Jul 2019to 31 Jan 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects age 18 or older.
  • Subjects who are able to provide written informed consent and to comply with study procedures.
  • Clinical history compatible with Type 1 diabetes (onset < 40 yrs old and insulin dependent for > 5 yrs at enrollment, c-peptide negative).
  • Recipients should have absent stimulated c-peptide (< 0.3 ng/mL) in response to a (Boost® 6 mL/kg BW to a maximum of 360 mL; another equivalent product), measured at 60 and 90 min after start of consumption.
  • Subjects who are > 6 months post-renal transplant or >6 months post-liver transplant who are taking appropriate calcineurin inhibitor (CNI) based maintenance immunosuppression ([tacrolimus alone or in conjunction with sirolimus, mycophenolate mofetil, myfortic, or azathioprine; or cyclosporine in conjunction with sirolimus, mycophenolate mofetil, or myfortic ± Prednisone ≤ 10 mg/day).
  • Stable renal function as defined by a creatinine of no more than one third greater than the average creatinine determination performed in the 6 previous months prior to islet transplant, as well as absence of a rejection episode in the 6 months prior to islet transplant
  • Stable liver function tests as defined by: SGOT (AST), SGPT (ALT), alkaline phosphatase values < 1.5, or total bilirubin < 1.5 times normal upper limits at time of study entry, as well as absence of a rejection episode in the 6 months prior to islet transplant

Who cannot join

  • Presence of donor specific anti-HLA antibodies detected by Luminex Single Antigen/specificity bead assay including weakly reactive antibodies that would not be detected by a flow cross match
  • Insulin requirement of >1.0 IU/kg/day
  • Weight more than 100 kg or body mass index (BMI) > 30 kg/m2.
  • Primary hyperparathyroidism OR secondary hyperparathyroidism
  • Untreated or unstable proliferative diabetic retinopathy.
  • Blood Pressure: SBP > 180 mmHg or DBP >100 mmHg despite treatment with antihypertensive agents.
Show all 25Show fewer
  • Calculated GFR of ≤ 40 mL/min/1.73 m2 using the subject's measured serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD- EPI) equation, as well as presence of a rejection episode in the 6 months prior to islet transplant
  • Elevated liver function tests as defined by: SGOT (AST), SGPT (ALT), alkaline phosphatase values > 1.5, or total bilirubin >1.5 times normal upper limits at time of study entry, as well as presence of a rejection episode in the 6 months prior to islet transplant
  • Proteinuria (albumin/creatinine ratio or ACr > 300mg/g) of new onset since kidney transplantation.
  • For female subjects: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant®, Depo- Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
  • Active infection including hepatitis B, hepatitis C, HIV, or TB. Quantiferon gold assay will be used to determine TB infection.
  • Invasive aspergillus, histoplasmosis, and coccidioidomycosis infection within 1 year prior to study entry.
  • Any history of malignancy following receiving either the kidney or liver transplant, except for completely resected squamous or basal cell carcinoma of the skin
  • Known active alcohol or substance abuse.
  • Severe co-existing cardiac disease, characterized by any one of these conditions:
  • Recent MI (within past 6 months),
  • Evidence of ischemia on functional cardiac exam within the last year,
  • Left ventricular ejection fraction < 30%,
  • Valvular disease requiring replacement with prosthetic valve.
  • Active infections (except mild skin and nail fungal infections).
  • Use of any investigational agents within 4 weeks of enrollment.
  • Administration of live attenuated vaccine(s) within 2 months of enrollment.
  • Any medical condition that, in the opinion of the investigator, will interfere with safe study completion.
  • Positive screen for BK viremia at time of screening.
  • Untreated hyperlipidemia - TC > 200 mg/dL, TGC > 200 mg/dL, LDL > 130 mg/dL

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: Pancreatic Islets and Parathyroid Gland Co-transplantation for Treatment of Diabetes in the Intra-Muscular Site

The primary objective is to test the hypothesis that co-transplantation of allogeneic PTG with adult pancreatic islets (derived from same deceased donor) in the IM site in people with Type 1 diabetes with functioning kidney and/or liver transplants is safe, allows islet engraftment, and leads to insulin independence.

Read the detailed description

Single-center, open label, non-randomized safety and efficacy trial to evaluate co-transplantation of allogeneic parathyroid glands (PTG) with adult pancreatic islets (both PTG and pancreatic islets obtained from same deceased donor) in people with Type 1 diabetes in the intramuscular (IM) site with stable function of liver or kidney allografts on chronic immunosuppression.

A total of 8 patients will be enrolled in the study and followed for a minimum of 1 year up to 2 years after the last islet transplant, depending on enrollment date.

Conditions
Type 1 Diabetes
Being tested
Co-transplantation of PTG with pancreatic islets
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.

  • Co-transplantation of PTG with pancreatic isletsCombination product

    Co-transplantation of allogeneic parathyroid glands (PTG) with adult pancreatic islets (both PTG and pancreatic islets obtained from same deceased donor) in people with Type 1 diabetes in the intramuscular (IM) site with stable function of liver or kidney allografts on chronic immunosuppression

Study groups in NCT03977662
Study groupRoleWhat they receive
PTG with adult pancreatic islet co-transplantationExperimentalPeople with Type 1 (c-peptide negative) diabetes with stable kidney or liver allografts on chronic immunosuppression who receive study intervention, which is co-transplantation of allogeneic parathyroid (PTG) with adult pancreatic islets in people with Type 1 diabetes in the intramuscular (IM) site
Receives: Combination Product: Co-transplantation of PTG with pancreatic islets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    Safety: Since this study is a pilot non-randomized safety and efficacy trial with patient enrollment limited by budgetary constraints, no direct statistical significance tests can be performed.

    Measured: Minimum of 1 year up to 2 years depending on transplant date

  2. Incidence of post-transplant infections and malignancies

    Safety: Since this study is a pilot non-randomized safety and efficacy trial with patient enrollment limited by budgetary constraints, no direct statistical significance tests can be performed.

    Measured: Minimum of 1 year up to 2 years depending on transplant date

  3. Incidence of de novo sensitization

    Safety: Since this study is a pilot non-randomized safety and efficacy trial with patient enrollment limited by budgetary constraints, no direct statistical significance tests can be performed.

    Measured: Minimum of 1 year up to 2 years depending on transplant date

  4. Incidence of Insulin independence

    Efficacy: Incidence of participants no longer using insulin

    Measured: Minimum of 1 year up to 2 years depending on transplant date

Secondary outcomes (5)

  1. Glycemic control

    Assessed by measuring HbA1c using high-performance liquid chromatography

    Measured: Day 75, Day 180, Day 270, Year 1, Year 1.5, Year 2

  2. Hypoglylcemic episodes: Clarke Survey Score

    The Clarke survey will be used to assess the frequency and severity of hypoglycemic episodes

    Measured: Day 75, Day 180, Day 270, Year 1

  3. Hypoglylcemic episodes: Hypo Score

    The HYPO score will be used to assess the frequency and severity of hypoglycemic episodes

    Measured: Day 75, Day 180, Day 270, Year 1

  4. Beta cell function as assessed by Mixed Meal Tolerance Test (MMTT)

    Results from both MMTT and FSIGT will be used to assess beta cell function

    Measured: Day 75, Day 180, Day 270, Year 1, Year 1.5, Year 2

  5. Beta cell function as assessed by Insulin-Modified Frequently-Sampled Intravenous Glucose ToleranceTest (FSIGT)

    Results from both MMTT and FSIGT will be used to assess beta cell function

    Measured: Day 75, Day 180, Day 270, Year 1, Year 1.5, Year 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2019
  2. Study start1 Jul 2019
  3. Primary completion31 Jan 2026
  4. Study completion31 Jan 2026

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03977662
Sponsor's protocol ID
18-26725
Acronym
PARADIGM
Status last verified
Mar 2026
First submitted
24 May 2019
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Co-transplantation of PTG with pancreatic islets in people with Type 1 Diabetes, run by Peter Stock 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 7 inclusion and 25 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 6 Mar 2026. 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?

Incidence of adverse events (time frame: Minimum of 1 year up to 2 years depending on transplant date). The study lists 4 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 NCT03977662.

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 6 Mar 2026.

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