Phase 2
N=8
Incretin Effect and Use After Clinical Islet Transplantation
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00768651 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: The Primary Endpoint Will be Insulin Independence After 6 Months of Therapy. — 0.25 proportion of participants — p=< 0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pantoprazole (Drug); Sitagliptin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alberta
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Endpoint Will be Insulin Independence After 6 Months of Therapy. |
0.25 | < 0.05 sig |
| PRIMARY Number of Participants Not Using Insulin for at Least One Week After 6 Months of Therapy |
— | — |
| PRIMARY Number of Participants With HbA1c < 6.0 % After 6 Months of Therapy |
— | — |
| PRIMARY Number of Participants With Fasting Plasma Glucose (FPG) < 7 mmol/l After 6 Months of Therapy |
— | — |
| PRIMARY Mean Daily Insulin Use (U/Day) After 6 Months of Therapy |
— | — |
| PRIMARY Change From Baseline of GLP-1 Level After One Month of Therapy |
— | — |
| PRIMARY Change From Baseline on Gastrin Level After One Month of Therapy |
— | — |
| PRIMARY HbA1c Plasma Laboratory Value for Participants After 6 Months of Therapy |
— | — |
| PRIMARY Acute Insulin Responses to Arginine After 6 Months of Therapy |
— | — |
| PRIMARY C-peptide Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy |
— | — |
| PRIMARY C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy |
— | — |
| PRIMARY Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy. |
— | — |
| PRIMARY Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy |
— | — |
| PRIMARY Weight Change From Baseline After 6 Months of Therapy |
— | — |
| SECONDARY Insulin Independence After the 3 Month Washout Period |
— | — |
| SECONDARY Insulin Dose (U/Day) |
— | — |
| SECONDARY Acute Insulin Response to Arginine After the 3 Month Washout Period |
— | — |
| SECONDARY HbA1c Plasma Laboratory Value for Participants After the 3 Month Washout Period |
— | — |
| SECONDARY C-peptide Plasma Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) at the End of the 3 Month Washout Period. |
— | — |
| SECONDARY C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period. |
— | — |
| SECONDARY Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period. |
— | — |
| SECONDARY Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period |
— | — |
Summary
We aim to study if the administration of medications to increase the secretion of hormones from the intestines can improve glycemic control, reduce insulin use and promote β-cell regeneration/expansion in subjects with type 1 diabetes following islet transplantation who are back using small doses of insulin because of early graft dysfunction. We believe that the results will enable us to understand whether these drugs could be useful in islet transplant recipients, particularly if glycemic control deteriorates.
Eligibility Criteria
Inclusion Criteria
Subjects must meet the following criteria to be enrolled in this study:
- Male or female, aged 18 to 70, inclusive, who is a previous islet transplant recipient (at least 3 months since last islet transplant) and who received their transplant at the University of Alberta.
- Insulin independent for 3 months or longer after islet transplant.
- Early graft dysfunction as defined by:
- HbA1c >6% (but less than 7.5%); or
- fasting glucose > 7 mmol/L (126 mg/dl); or
- random glucose > 10 mmol/L (180 mg/dl), and
- Total insulin use of < 10 units/day.
- C-peptide positive.
- Able to provide informed consent.
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from the study:
- Unable to provide informed consent.
- Prior therapy with sitagliptin or a proton pump inhibitor in the preceding 2 months.
- Vulnerable populations (i.e. cognitively impaired, pregnant women, residing in institutions, University of Alberta students or employees under the supervision of any of the investigators).
- Children, adolescent or patients with a "contraindication" or "warning" listed in the package insert of any of the study drugs:
- Hypersensitivity to sitagliptin or pantoprazole for any component of the formulation.
- Renal disease or renal dysfunction (as suggested by serum creatinine levels ≥ 136 µmol/L (males), ≥ 124 µmol/L (females) or abnormal creatinine clearance; or estimated by Glomerular Filtration Rate (GFR) <50 ml/min/1.73m2).
- Acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis).
- Uncontrolled hyperglycemia
- Any subject that in the opinion of the investigator would not be a good candidate for study participation.
Data sourced from ClinicalTrials.gov (NCT00768651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.