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Sitagliptin Dose Determination Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01530178
First Posted: February 9, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rubina Heptulla, Albert Einstein College of Medicine of Yeshiva University
  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
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Sitagliptin Dose Determination Study in Type 1 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 20% difference in mean AUC for glucose [ Time Frame: 300 minute period ]
    The current trial is designed to detect a 20% difference in mean AUC for glucose in the 300 minute period to 376mg*hr/dl.


Enrollment: 7
Study Start Date: November 2011
Study Completion Date: March 2015
Primary Completion Date: March 2015 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530178


Locations
United States, New York
Albert Einstein College of Medicine CRC
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
Investigators
Principal Investigator: Rubina Heptulla, MD Albert Einstein College of Medicine, Inc.
  More Information

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
First Submitted: February 6, 2012
First Posted: February 9, 2012
Last Update Posted: October 12, 2017
Last Verified: June 2015

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

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