Novel Therapy to Preserve Beta Cell Function in New Onset Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT00837759 |
Recruitment Status
:
Terminated
(Changes to study personnel.)
First Posted
: February 5, 2009
Results First Posted
: October 24, 2012
Last Update Posted
: January 3, 2013
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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.
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus Type 1 Autoimmune Diabetes | Drug: Insulin Drug: Lansoprazole Drug: Sitagliptin Biological: Diamyd Drug: GAD65 (Diamyd) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Novel Therapy Combining Regenerative Stimuli Immunomodulation to Preserve Beta Cell Function in New Onset Type 1 Diabetes |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | March 2011 |
Actual Study Completion Date : | March 2011 |

Arm | Intervention/treatment |
---|---|
T1D group
This 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.
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Drug: Insulin Drug: Lansoprazole Drug: Sitagliptin Biological: Diamyd Drug: GAD65 (Diamyd) |
- Change in C-peptide [ Time Frame: 6 months following the protocol subject's randomization/treatment initiation ]
- Glycemia Control (Change in HbA1c Level) [ Time Frame: 6 months following the protocol subject's randomization/treatment initiation ]
- Change in Insulin Dose [ Time Frame: 6 months following the protocol subject's randomization/treatment initiation ]
- Change in Anti-GAD Autoantibody Titers [ Time Frame: 6 months following the protocol subject's randomization/treatment initiation ]
- Change in Anti-IA2 Titer [ Time Frame: 6 months following the protocol subject's randomization/treatment initiation ]
- Change in ZnT8 Autoantibody Titer [ Time Frame: 6 months following the protocol subject's randomization/treatment initiation ]

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Ages Eligible for Study: | 16 Years to 30 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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INCLUSION CRITERIA:
-
Recently diagnosed (within the preceding 4 months of screening) diabetes clinically consistent with T1D:
A. Positive for anti-GAD antibody.
B. 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.
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EXCLUSION CRITERIA:
- 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
- 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):
A. Clinically significant past history of an acute reaction to vaccines or other drugs
B. Recent participation in other clinical trials with a new chemical entity
C. A history of alcohol or drug abuse
D. Significant neurological conditions like epilepsy, head trauma, or cerebrovascular accidents
E. 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
F. Individuals with conditions prone to hypergastrinemia (Zollinger-Ellison syndrome, use of histamine-2 receptor blockers) or hypogastrinemia (gastric surgery).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837759
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | |
Bethesda, Maryland, United States, 20892 |
Study Director: | Balow James, MD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Publications:
Responsible Party: | James Balow, Clinical Director Intramural NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00837759 History of Changes |
Other Study ID Numbers: |
090056 09-DK-0056 ( Other Identifier: National Institutes of Health Clinical Center ) 09-DK-0056 ( Other Identifier: NIHCC ) |
First Posted: | February 5, 2009 Key Record Dates |
Results First Posted: | October 24, 2012 |
Last Update Posted: | January 3, 2013 |
Last Verified: | December 2012 |
Keywords provided by James Balow, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Type I Diabetes Preserve Beta Cell Function Sitagliptin Lansoprazole |
GAD65 (Diamyd) Diabetes Type 1 Diabetes T1DM |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Sitagliptin Phosphate Lansoprazole Dexlansoprazole Hypoglycemic Agents |
Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors |