Overview

Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes

Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the effects of sitagliptin on glucose variability both after meals and overnight in adult patients with type 1 diabetes.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Colorado Denver School of Medicine Barbara Davis Center
Treatments:
Sitagliptin Phosphate
Criteria
Inclusion Criteria:

- Male or female adult, aged 18 to 70 years

- Type 1 diabetes mellitus as established by medical history

- Current treatment with MDI or CSII 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 the total duration of the study

- Willing to complete a routine medical visits every 3 months

- Willing to complete a total of 7 phone visits

- Able to speak, read, and write English

Exclusion Criteria:

- On oral, inhaled or pre-mixed insulin

- On Symlin

- BMI > 35 kg/m2

- 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

- Diagnosis of anemia

- HbA1C greater than 12%

- 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 a medical known allergy to adhesives

- Subjects who have an allergy to medication being used

- Currently participation in another investigational study protocol. Must have completed
a previous study at least 30 days prior to being enrolled in this one

- Have any condition that, in the opinion of the Investigator, would interfere with
their participation in the trial.