Sitagliptin in Type I Diabetic Patients

NCT01741103 | Withdrawn

• 1 other identifier: 1957
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Type I

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Glycemic changes

  baseline and 3 months

• Post meal hyperglycemia

  baseline and 3 months

• Changes in post prandial glucose, glucagon, insulin, c-peptide, DPP-IV, GIP and, GLP-1 concentrations following meal challenge.

  baseline and 3 months

• Changes in NF kappa B in the fasting state.

  baseline and 3 months

• Change in NFkappaB following meal challenge.

  baseline and 3 Months

Study Arms (2)

Sitagliptin

EXPERIMENTAL

Drug: sitagliptin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

sitagliptin DRUG

sitagliptin 100mg by mouth once a day for 12 weeks

Also known as: Januvia/Sitagliptin 100mg

Sitagliptin

Placebo DRUG

Take one by mouth daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University at Buffalo: lead

Study Sites (1)

115 Flint Road

Williamsville, New York, 14221, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Paresh Dandona, MD

  Kaleida Health and University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Medicine

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: December 4, 2012
• Study Start: June 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

US (1)