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

Completed · Phase 4

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT00978796

Run by

University of Colorado, Denver

People needed

20

Starts

2009-09-01

Expected to finish

2010-03-01

Last updated by the study team

2010-03-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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