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Sitagliptin in Type I Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741103
Recruitment Status : Unknown
Verified June 2012 by Paresh Dandona, MD, Kaleida Health.
Recruitment status was:  Recruiting
First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
Paresh Dandona, MD, Kaleida Health

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
Diabetes Type I Drug: sitagliptin Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 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 : June 2011
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sitagliptin Drug: sitagliptin
sitagliptin 100mg by mouth once a day for 12 weeks
Other Name: Januvia/Sitagliptin 100mg

Placebo Comparator: Placebo Drug: Placebo
Take one by mouth daily for 12 weeks




Primary Outcome Measures :
  1. change from baseline in mean glucose concentrations [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: baseline and 3 months ]
  4. Changes in NF kappa B in the fasting state. [ Time Frame: baseline and 3 months ]
  5. Change in NFkappaB following meal challenge. [ Time Frame: baseline and 3 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741103


Contacts
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Contact: Paresh Dandona, MD 716-887-4069 pdandona@kaleidahealth.org

Locations
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United States, New York
115 Flint Road Recruiting
Williamsville, New York, United States, 14221
Contact: Paresh Dandona, MD    716-626-7998    pdandona@kaleidahealth.org   
Sponsors and Collaborators
Kaleida Health
Investigators
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Principal Investigator: Paresh Dandona, MD Kaleida Health and University at Buffalo
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Responsible Party: Paresh Dandona, MD, Clinical Professor of Medicine, Kaleida Health
ClinicalTrials.gov Identifier: NCT01741103    
Other Study ID Numbers: 1957
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action