Diabetes Type I
Conditions
Brief summary
The purpose of the study is to evaluate the effect of sitagliptin on overall blood glucose concentrations in Type I Diabetic subjects. The study also aims to evaluate post meal glucagon concentrations in Type I Diabetic subjects (a possible mechanism of reduced blood glucose concentrations) and indices of oxidation stress in the plasma of these subjects.
Detailed description
The hypothesis is that Sitagliptin will improve overall blood glucose, fasting blood glucose, and glycemic excursions in patients with Type I Diabetes. In addition, sitagliptin will likely suppress indices of oxidative stress in patients. The study will investigate proposed mechanisms of improved glucose concentrations, including enhanced effect of endogenous GLP-1 and suppression of glucagon.
Interventions
DRUGsitagliptin
sitagliptin 100mg by mouth once a day for 12 weeks
DRUGPlacebo
Take one by mouth daily for 12 weeks
Sponsors
University at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female adult, aged 18 to 70 years 2. Type 1 Diabetes Mellitus for 6 months or more, as established by medical history 3. Current treatment with multiple injections of insulin (at least 4) or CSII (continuous subcutaneous insulin infusion or insulin pump) therapy for at least 3 months prior to screening visit; and using the same insulin during the last 1 month 4. HbA1c ≤ 8.5% 5. Subjects should routinely practice at least 2-4 blood glucose measurements per day 6. BMI ≤ 35 kg/m2 7. Subject must be able and willing to perform self-blood glucose monitoring and accept wearing a continuous glucose monitor for 3 days at the start and 3 days at the end of the study 8. Subjects must be willing to complete study visits per study protocol 9. Able to speak, read, and write English
Exclusion criteria
1. Type 1 Diabetes Mellitus for less than 6 months 2. Coronary Event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery, or coronary angioplasty) in the previous 4 weeks 3. Any other life-threatening, non-cardiac disease 4. Pregnant or intends to become pregnant during the course of the study 5. Severe unexplained hypoglycemia that required emergency treatment over the past 3 months 6. History of hemoglobinopathies 7. Post-renal transplantation, currently undergoing dialysis, creatinine of \>1.5mg/dl or a calculated creatinine clearance of \<50 mL/min. 8. Have extensive skin changes/diseases that inhibit wearing the sensor on normal skin 9. Subjects who have an allergy to medication being used 10. Current participation in another study protocol 11. History of autonomic neuropathy or gastroparesis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in mean glucose concentrations | baseline and 3 months | The primary endpoint of the study is to detect the change from baseline in mean glucose concentrations as measured by both HbA1c, and mean glucose over the three days of continuous glucose monitoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic changes | baseline and 3 months | Glycemic changes including standard deviations of the glycemic levels, fructosamine, and the duration of time spent in hyperglycemia and hypoglycemia. |
| Post meal hyperglycemia | baseline and 3 months | Post meal hyperglycemia will be measured as area under the curve (AUC). |
| Changes in post prandial glucose, glucagon, insulin, c-peptide, DPP-IV, GIP and, GLP-1 concentrations following meal challenge. | baseline and 3 months | — |
| Changes in NF kappa B in the fasting state. | baseline and 3 months | — |
| Change in NFkappaB following meal challenge. | baseline and 3 Months | — |
Countries
United States
Outcome results
None listed