A Phase 2 interventional study of Insulin and Lansoprazole in Diabetes Mellitus Type 1 and Autoimmune Diabetes, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Terminated at 1 site in United States. Open to participants aged 16 Years to 30 Years. Per ClinicalTrials.gov, last updated 2013-01-03.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 2, Interventional, and Treatment
Background:
Objectives:
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 7 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.
Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
EXCLUSION CRITERIA:
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).
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.
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
| Milestone | T1D Group |
|---|---|
| Started | 7 |
| Completed | 3 |
| Not completed | 4 |
| Withdrew: Protocol violation | 3 |
| Withdrew: Lost to follow-up | 1 |
| ng/mL | T1D Group |
|---|---|
| Change in C-peptide | 0.51 ± 0.53 |
| Percentage | T1D Group |
|---|---|
| Glycemia Control (Change in HbA1c Level) | -1.17 ± 0.45 |
| U/kg/day | T1D Group |
|---|---|
| Change in Insulin Dose | 0.02 ± 0.32 |
| Titers | T1D Group |
|---|---|
| Change in Anti-GAD Autoantibody Titers | 119278 ± 174649 |
| Titers | T1D Group |
|---|---|
| Change in Anti-IA2 Titer | -29212 ± 49956 |
| Titers | T1D Group |
|---|---|
| Change in ZnT8 Autoantibody Titer | -0.11 ± 0.19 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| T1D Group | — | 0/7 (0%) | 3/7 (42.9%) |
| Event | T1D Group |
|---|---|
| Hypoglycemic eventsMetabolism and nutrition disorders | 3/3 |
| RhinitisGeneral disorders | 1/3 |
| EczemaGeneral disorders | 1/3 |
| WartsGeneral disorders | 1/3 |
| ThrombocytopeniaGeneral disorders | 1/3 |
| GastroenteritisGeneral disorders | 1/3 |
| AnemiaGeneral disorders | 1/3 |
| Age, Categorical(Participants) | T1D Group |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 6 |
| >=65 years | 0 |
| Age Continuous(years) | T1D Group |
|---|---|
| Mean | 21.9 ± 3.2 |
| Sex: Female, Male(Participants) | T1D Group |
|---|---|
| Female | 2 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | T1D Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | T1D Group |
|---|---|
| United States | 7 |
This study is terminated, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)