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Sitagliptin in Type I Diabetic Patients

Sponsor
University at Buffalo (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01741103
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
27
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Sitagliptin on Glycemic Control, Post-prandial Glucagon, and Inflammation in Type 1 Diabetics
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sitagliptin

Drug: sitagliptin
sitagliptin 100mg by mouth once a day for 12 weeks
Other Names:
  • Januvia/Sitagliptin 100mg

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    Take one by mouth daily for 12 weeks

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    2. Post meal hyperglycemia [baseline and 3 months]

      Post meal hyperglycemia will be measured as area under the curve (AUC).

    3. Changes in post prandial glucose, glucagon, insulin, c-peptide, DPP-IV, GIP and, GLP-1 concentrations following meal challenge. [baseline and 3 months]

    4. Changes in NF kappa B in the fasting state. [baseline and 3 months]

    5. Change in NFkappaB following meal challenge. [baseline and 3 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 115 Flint Road Williamsville New York United States 14221

    Sponsors and Collaborators

    • University at Buffalo

    Investigators

    • Principal Investigator: Paresh Dandona, MD, Kaleida Health and University at Buffalo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paresh Dandona, Clinical Professor of Medicine, Kaleida Health
    ClinicalTrials.gov Identifier:
    NCT01741103
    Other Study ID Numbers:
    • 1957
    First Posted:
    Dec 4, 2012
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 1
    Sitagliptin Phosphate

    Study Results

    No Results Posted as of Mar 24, 2022