Sitagliptin Dose Determination Study

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1

In brief

There are many recent advances in insulin treatment of type 1 diabetes, however after a meal sugars are always a concern. There is a drug sitagliptin (Januvia) which is FDA approved to treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals. This study is going to test whether this drug can improve the after meal sugars in people with type 1 diabetes. To test this you will be given a test mixed meal and its effects on insulin, other hormones that affect blood glucose as well as your sugar will be measured by a series of blood tests. Insulin dose will be reduced by 20-50% to prevent low blood sugars which might occur because of food staying longer in the stomach than usual or due to the suppression of a hormone called glucagon which increases blood sugar. If you qualify you will be given sitagliptin (Januvia) 3 different times in 25 mg, 50 mg and 100mg dosages. You and the researchers will not know which dose you are taking at any single visit. A total of 30 people in which some will be children aged 13- 17 and others will be adults aged 18-30 will participate. Some will have had diabetes for over a year, others will be within 3 months of having been found to have type 1 diabetes. Furthermore, only 18-30 year people who are diagnosed with type 1 diabetes for a year or more will be studied initially (4 subjects) to establish safety data before younger subjects are enrolled into the study.

Key facts

Study ID

NCT01530178

Run by

Albert Einstein College of Medicine

People needed

8

Starts

2011-11-01

Expected to finish

2015-03-01

Last updated by the study team

2018-07-16

Who can join

Age: 13 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age of 13 to 30 years
• Subjects must be otherwise healthy except for T1DM, and treated for hypothyroidism if present
• Menstruating women must have negative pregnancy test.
• Hemoglobin (Hb) more than 12 g/dl

You may not qualify if…

• Having any other chronic condition except hypothyroidism stable on medications
• On chronic medications that may affect glucose excursions
• Hemoglobin less than 12 g/dl
• Positive pregnancy test (based on Urine)
• Pregnant or lactating mothers
• Known allergy to Januvia

Where it is running

• Albert Einstein College of Medicine CRC — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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