The Role of Phosphodiesterase Inhibitors in Incretin Secretion
Status:
Completed
Trial end date:
2016-09-19
Target enrollment:
Participant gender:
Summary
Background:
The drug Roflumilast (Daliresp) is used to treat Chronic Obstructive Pulmonary Disease
(COPD). COPD is a lung disease that makes it difficult to breathe. Studies have shown that
this drug decreased the blood sugar of people with type 2 diabetes. Sitagliptin (Januvia) is
a medication presently used to treat diabetes. Researchers think that both of these drugs may
decrease blood sugar by causing an increase in the hormone GLP-1.This hormone is secreted in
the small intestines and stomach and is also known as an incretin. Researchers want to study
how these drugs affect blood sugar, insulin, and other hormones in the blood.
Objectives:
- To study the effects of Roflumilast (Daliresp) and Sitagliptin (Januvia) on blood sugar
and insulin.
- To better understand GLP-1 and other gut hormones. This may lead to new treatments for
type 2 diabetes.
Eligibility:
- Healthy volunteers age 21 55.
- Body Mass Index (BMI) less than 30
Design:
-This study will require one screening visit and four study visits, scheduled about 3-weeks
apart.
Screening visit requires participants to arrive after fasting for 10 hours and have the
following:
- Medical history, physical exam, height, weight, blood pressure measurements and blood
and urine tests.
- A 2-hour oral glucose tolerance test (OGTT). Participants will drink an orange-flavored
drink containing 75 grams of sugar (300 calories). A blood sample will be taken prior to
drinking the beverage and 2-hours later.
- An electrocardiogram (EKG) to measure the electrical activity of the heart.
- Questionnaires about risk for depression or suicide.
Study visits 1to 4:
- Participants will arrive the evening prior and blood work will be done to confirm
eligibility. They will not eat or drink anything except water starting at 8:00 p.m.
- About 6:30 a.m. the following day, an I.V. (small plastic tube) will be placed in an arm
vein and used to take 20 blood samples over a period of about 11 hours.
- Participants will receive one of the following study medication/placebo groupings in
random order:
1. Roflumilast (Daliresp) 500 mcg pill; and 1 placebo pill
2. Sitaglipitin (Januvia) 100 mg pill; and 1 placebo pill
3. Roflumilast (Daliresp) 500 mcg pill; and Sitagliptin (Januvia) 100 mg pill
4. 2 placebo pills
- One hour later, they will have a 10-hour mixed meal test (MMT). They will be asked to
drink a nutritional shake (Ensure Plus). Blood samples will be taken over the next 10
hours to measure blood sugar, insulin and other hormones. At the end of the test, they
will be given a meal.
- Participants will answer questions about side effects and symptoms. They will receive a
follow-up phone call within 10 days.