Overview
Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes
Status:
Completed
Completed
Trial end date:
2010-03-01
2010-03-01
Target enrollment:
0
0
Participant gender:
All
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 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of Colorado Denver School of Medicine Barbara Davis CenterTreatments:
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.