AzTrials
AzTrials

Diabetes Mellitus Type 1Phase 2NCT00837759

Novel Therapy to Preserve Beta Cell Function in New Onset Type 1 Diabetes

A Phase 2 study testing Insulin, Lansoprazole and Sitagliptin in people with Diabetes Mellitus Type 1 and Autoimmune Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Background: Type 1 diabetes (T1D) occurs when the immune system attacks insulin-producing cells (beta cells) in the pancreas, resulting in their death. Insulin injections currently are the best method for controlling blood sugar in individuals with T1D. Read more about this study

Who is it for?
Ages 16 to 30 years
Conditions the study is for
Diabetes Mellitus Type 1, Autoimmune Diabetes
What is being tested?
Insulin, Lansoprazole and Sitagliptin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
Feb 2009to Mar 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 16 to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Recently diagnosed (within the preceding 4 months of screening) diabetes clinically consistent with T1D:
  • Positive for anti-GAD antibody.
  • BMI between 19 and 28 kg/m2; for those between the ages of 16 to 18, the BMI must be within 10th to 90th percentile for the age.
  • Ages between 16 and 30 years, inclusive
  • Random plasma C-peptide level of equal to or greater than 0.20 nmol/L
  • Willingness and ability to institute intensive insulin-based glucose management.

Who cannot join

  • Diabetic nephropathy with a creatinine clearance less than 60 cc/min or 24 hour urine albumin greater than 300 mg
  • Insulin requirements greater than 0.8 units/kg/day at the end of the run-in period
  • Regular use of a proton pump inhibitor within 3 months of enrollment
  • Use of GLP-1R agonist or DPP-4 inhibitor within 6 months prior to enrollment
  • Use of immunosuppressive therapy in the preceding 12 months
  • Evidence of chronic infection, for example, known human immunodeficiency virus (HIV) or hepatitis
Show all 16Show fewer
  • History of any malignancy other than a treated basal or squamous skin cancer
  • Any chronic medical condition to unduly increase risk for the potential enrollee as judged by study investigators
  • Pregnancy, breastfeeding or planned pregnancy within two years, women of reproductive age not using an effective mode of contraception and unwilling to continue adequate contraception until 1 year after the last study drug administration
  • Any other co-existing condition/circumstances that would make patient unsuitable to participate in the study, as deemed by the investigators. For example, study investigators would exclude any potential candidate with any of the following (but the list is not inclusive):
  • Clinically significant past history of an acute reaction to vaccines or other drugs
  • Recent participation in other clinical trials with a new chemical entity
  • A history of alcohol or drug abuse
  • Significant neurological conditions like epilepsy, head trauma, or cerebrovascular accidents
  • Individuals with significant gastrointestinal disorders determined by the study investigators to influence either study safety or data interpretation. Such conditions include but are not limited to gastroparesis and gastric bypass surgery
  • Individuals with conditions prone to hypergastrinemia (Zollinger-Ellison syndrome, use of histamine-2 receptor blockers) or hypogastrinemia (gastric surgery).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Novel Therapy Combining Regenerative Stimuli Immunomodulation to Preserve Beta Cell Function in New Onset Type 1 Diabetes

Background:

  • Type 1 diabetes (T1D) occurs when the immune system attacks insulin-producing cells (beta cells) in the pancreas, resulting in their death.
  • Insulin injections currently are the best method for controlling blood sugar in individuals with T1D. However, animal studies have shown that the drugs sitagliptin and lansoprazole can help reverse beta cell damage or develop new beta cells. In addition, Diamyd has been shown to weaken the immune process that attacks pancreatic beta cells.
Read more

Objectives:

  • To find out whether a combination treatment of sitagliptin, lansoprazole, and Diamyd will help maintain functioning beta cells and/or cause new beta cells to form.
  • To determine how the drug combination affects insulin doses and blood sugar control.
  • To determine whether the drug combination affects the immune response involved in T1D.
Read the detailed description

Type 1 diabetes (T1D) is the end result of immune mediated beta-cell destruction. It is generally accepted that at the time of T1D is diagnosed, an individual has lost most (60-80%) of his/her beta cell function. The loss of insulin-producing beta cells is believed to occur over a period of months to years and individuals can retain some endogenous insulin production even years after clinical diagnosis of diabetes. The presence of residual beta cell mass may signify a complex interplay between the auto-destructive immune response and the capacity for limited beta cell regeneration. When initiated at T1D onset, immunosuppression has been shown to preserve beta cell function, but with significant and limiting toxicities. Selectively targeting the pathogenic T-cells involved in T1D development and progression could achieve the same objective with less toxicity. Various studies of the non-obese diabetic (NOD) mouse model of spontaneous autoimmune diabetes have demonstrated that administering glutamic acid decarboxylase (GAD65), a beta cell autoantigen, can prevent the immune destruction and delay or prevent diabetes onset. Preclinical studies have also identified several growth factors, including epidermal growth factor (EGF), glucagon-like peptide 1 (GLP-1), and gastrin, that appear to promote beta cell proliferation. We seek to test the potential for preserving beta cell function early in the disease course of T1D by combining antigen-specific immunomodulation with regenerative stimuli.

Being tested
Insulin, Lansoprazole, Sitagliptin, Diamyd, GAD65 (Diamyd)
Keywords
Type I Diabetes, Preserve Beta Cell Function, Sitagliptin, Lansoprazole, GAD65 (Diamyd), Diabetes, Type 1 Diabetes, T1DM
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.

Study groups in NCT00837759
Study groupRoleWhat they receive
T1D groupOtherThis study was terminated prior to full subject accrual because of changes to study personnel. The original study design was changed from a double-blind, placebo-controlled study to an open-label pilot study in order to collect safety data on enrolled subjects prior to study termination.
Receives: Drug: Insulin; Drug: Lansoprazole; Drug: Sitagliptin; Biological: Diamyd; Drug: GAD65 (Diamyd)

What is being measured

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

  1. Change in C-peptide

    Measured: 6 months following the protocol subject's randomization/treatment initiation

Secondary outcomes (5)

  1. Glycemia Control (Change in HbA1c Level)

    Measured: 6 months following the protocol subject's randomization/treatment initiation

  2. Change in Insulin Dose

    Measured: 6 months following the protocol subject's randomization/treatment initiation

  3. Change in Anti-GAD Autoantibody Titers

    Measured: 6 months following the protocol subject's randomization/treatment initiation

  4. Change in Anti-IA2 Titer

    Measured: 6 months following the protocol subject's randomization/treatment initiation

  5. Change in ZnT8 Autoantibody Titer

    Measured: 6 months following the protocol subject's randomization/treatment initiation

Timeline

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

  1. First posted5 Feb 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionMar 2011
  4. Study completionMar 2011

Why it stopped: Changes to study personnel.

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00837759
Sponsor's protocol ID
090056
Other IDs
09-DK-0056, 09-DK-0056
Status last verified
Dec 2012
First submitted
4 Feb 2009
Last updated
3 Jan 2013
Data monitoring committee
No

Publications

  • Bach JF, Chatenoud L. Tolerance to islet autoantigens in type 1 diabetes. Annu Rev Immunol. 2001;19:131-61. doi: 10.1146/annurev.immunol.19.1.131.

    PubMed 11244033

  • Lernmark A, Barmeier H, Dube S, Hagopian W, Karlsen A, Wassmuth R. Autoimmunity of diabetes. Endocrinol Metab Clin North Am. 1991 Sep;20(3):589-617.

    PubMed 1935920

  • Mathis D, Vence L, Benoist C. beta-Cell death during progression to diabetes. Nature. 2001 Dec 13;414(6865):792-8. doi: 10.1038/414792a.

    PubMed 11742411

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Insulin, Lansoprazole and Sitagliptin in people with Diabetes Mellitus Type 1 and Autoimmune Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 6 inclusion and 16 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: stopped early, as of the sponsor's last update on 3 Jan 2013. 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 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?

Yes. Results are posted in the registry (first posted 24 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 C-peptide (time frame: 6 months following the protocol subject's randomization/treatment initiation). 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 NCT00837759, which also lists 3 linked publications.

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 3 Jan 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in