MedTrace Logo

Sitagliptin Dose Determination Study

NCT01530178 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-07-16

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Sitagliptin

In each intervention arm the participant receives a different dose of sitagliptin.

DRUG

Placebo Oral Tablet

Sponsors & Collaborators

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Rubina Heptulla, MD · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
13 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01530178 on ClinicalTrials.gov