Sitagliptin in Type I Diabetic Patients

Diabetes Type I Clinical Trial

Official title:

Effect of Sitagliptin on Glycemic Control, Post-prandial Glucagon, and Inflammation in Type 1 Diabetics

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01741103
• Other study ID #: 1957
• Status: Withdrawn
• Phase: N/A
• Start date: June 2011
• Est. completion date: September 2013

Study information

• Verified date: March 2022
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetes Type I

Intervention

Drug:
• sitagliptin
sitagliptin 100mg by mouth once a day for 12 weeks
• Placebo
Take one by mouth daily for 12 weeks

Locations

Country	Name	City	State
United States	115 Flint Road	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
University at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in mean glucose concentrations	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.	baseline and 3 months
Secondary	Glycemic changes	Glycemic changes including standard deviations of the glycemic levels, fructosamine, and the duration of time spent in hyperglycemia and hypoglycemia.	baseline and 3 months
Secondary	Post meal hyperglycemia	Post meal hyperglycemia will be measured as area under the curve (AUC).	baseline and 3 months
Secondary	Changes in post prandial glucose, glucagon, insulin, c-peptide, DPP-IV, GIP and, GLP-1 concentrations following meal challenge.		baseline and 3 months
Secondary	Changes in NF kappa B in the fasting state.		baseline and 3 months
Secondary	Change in NFkappaB following meal challenge.		baseline and 3 Months