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Sitagliptin in Type I Diabetic Patients

Primary Purpose

Diabetes Type I

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
sitagliptin
Placebo
Sponsored by
University at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Type I

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 115 Flint Road

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sitagliptin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Glycemic changes
Glycemic changes including standard deviations of the glycemic levels, fructosamine, and the duration of time spent in hyperglycemia and hypoglycemia.
Post meal hyperglycemia
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.
Changes in NF kappa B in the fasting state.
Change in NFkappaB following meal challenge.

Full Information

First Posted
September 27, 2011
Last Updated
March 8, 2022
Sponsor
University at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT01741103
Brief Title
Sitagliptin in Type I Diabetic Patients
Official Title
Effect of Sitagliptin on Glycemic Control, Post-prandial Glucagon, and Inflammation in Type 1 Diabetics
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study funding was for 1 year to a fellow who graduated in early stages of enrollment. While 6 patients were enrolled, many patients didn't finish the study and therefore little data was collected and no results will be entered.
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type I

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sitagliptin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
sitagliptin
Other Intervention Name(s)
Januvia/Sitagliptin 100mg
Intervention Description
sitagliptin 100mg by mouth once a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Take one by mouth daily for 12 weeks
Primary Outcome Measure Information:
Title
change from baseline in mean glucose concentrations
Description
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.
Time Frame
baseline and 3 months
Secondary Outcome Measure Information:
Title
Glycemic changes
Description
Glycemic changes including standard deviations of the glycemic levels, fructosamine, and the duration of time spent in hyperglycemia and hypoglycemia.
Time Frame
baseline and 3 months
Title
Post meal hyperglycemia
Description
Post meal hyperglycemia will be measured as area under the curve (AUC).
Time Frame
baseline and 3 months
Title
Changes in post prandial glucose, glucagon, insulin, c-peptide, DPP-IV, GIP and, GLP-1 concentrations following meal challenge.
Time Frame
baseline and 3 months
Title
Changes in NF kappa B in the fasting state.
Time Frame
baseline and 3 months
Title
Change in NFkappaB following meal challenge.
Time Frame
baseline and 3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female adult, aged 18 to 70 years Type 1 Diabetes Mellitus for 6 months or more, as established by medical history 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 HbA1c ≤ 8.5% Subjects should routinely practice at least 2-4 blood glucose measurements per day BMI ≤ 35 kg/m2 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 Subjects must be willing to complete study visits per study protocol Able to speak, read, and write English Exclusion Criteria: Type 1 Diabetes Mellitus for less than 6 months Coronary Event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery, or coronary angioplasty) in the previous 4 weeks Any other life-threatening, non-cardiac disease Pregnant or intends to become pregnant during the course of the study Severe unexplained hypoglycemia that required emergency treatment over the past 3 months History of hemoglobinopathies Post-renal transplantation, currently undergoing dialysis, creatinine of >1.5mg/dl or a calculated creatinine clearance of <50 mL/min. Have extensive skin changes/diseases that inhibit wearing the sensor on normal skin Subjects who have an allergy to medication being used Current participation in another study protocol History of autonomic neuropathy or gastroparesis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paresh Dandona, MD
Organizational Affiliation
Kaleida Health and University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
115 Flint Road
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States

12. IPD Sharing Statement

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Sitagliptin in Type I Diabetic Patients

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