Sitagliptin in Type I Diabetic Patients

NCT ID: NCT01741103

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-09-30

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.

Conditions

Diabetes Type I

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sitagliptin

Group Type: EXPERIMENTAL

sitagliptin

Intervention Type: DRUG

sitagliptin 100mg by mouth once a day for 12 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Take one by mouth daily for 12 weeks

Interventions

sitagliptin

sitagliptin 100mg by mouth once a day for 12 weeks

Intervention Type: DRUG

Placebo

Take one by mouth daily for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Januvia/Sitagliptin 100mg

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Paresh Dandona

Clinical Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paresh Dandona, MD

Role: PRINCIPAL_INVESTIGATOR

Kaleida Health and University at Buffalo

Locations

115 Flint Road

Williamsville, New York, United States

Countries

United States

Other Identifiers

1957

Identifier Type: -

Identifier Source: org_study_id