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Sitagliptin Dose Determination Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Information provided by (Responsible Party):
Rubina Heptulla, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01530178
First received: February 6, 2012
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: Sitagliptin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Sitagliptin Dose Determination Study in Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • 20% difference in mean AUC for glucose [ Time Frame: 300 minute period ] [ Designated as safety issue: No ]
    The current trial is designed to detect a 20% difference in mean AUC for glucose in the 300 minute period to 376mg*hr/dl.


Estimated Enrollment: 30
Study Start Date: November 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Part A
Sitagliptin 25mg
Drug: Sitagliptin
In each intervention arm the participant receives a different dose of sitagliptin.
Other Name: Januvia
Active Comparator: Part B
Sitagliptin 50mg
Drug: Sitagliptin
In each intervention arm the participant receives a different dose of sitagliptin.
Other Name: Januvia
Active Comparator: Part C
Sitagliptin 100mg
Drug: Sitagliptin
In each intervention arm the participant receives a different dose of sitagliptin.
Other Name: Januvia
Placebo Comparator: Part D
Placebo
Drug: Sitagliptin
In each intervention arm the participant receives a different dose of sitagliptin.
Other Name: Januvia

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Having any other chronic condition except hypothyroidism stable on medications
  2. On chronic medications that may affect glucose excursions
  3. Hemoglobin less than 12 g/dl
  4. Positive pregnancy test (based on Urine)
  5. Pregnant or lactating mothers
  6. Known allergy to Januvia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530178

Contacts
Contact: Jeniece Trast, RN, CDE, MA 718-741-2542 jtrast@montefiore.org
Contact: Gina DiNapoli, PNP, CDE 718-920-5476 gdinapol@montefiore.org

Locations
United States, New York
Albert Einstein College of Medicine CRC Recruiting
Bronx, New York, United States, 10461
Contact: Jeniece Trast, RN, CDE, MA    718-741-2542    jtrast@montefiore.org   
Principal Investigator: Rubina Heptulla, MD         
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Rubina Heptulla, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Rubina Heptulla, Division Chief of Pediatric Endocrinology & Diabetes, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01530178     History of Changes
Other Study ID Numbers: 2011-246
Study First Received: February 6, 2012
Last Updated: September 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Diabetes Mellitus, Type 1

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014