Sitagliptin Dose Determination Study

NCT01530178 | Completed Phase 4 Results DMC

• 1 other identifier: 2011-246
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Better Targeted Blood Glucose Levels

  The current trial is designed to detect a significant difference in the mean glucose levels in the treatment group

  1 Year

Study Arms (4)

Part A

ACTIVE COMPARATOR

Sitagliptin 25mg

Drug: Sitagliptin

Part B

ACTIVE COMPARATOR

Sitagliptin 50mg

Drug: Sitagliptin

Part C

ACTIVE COMPARATOR

Sitagliptin 100mg

Drug: Sitagliptin

Part D

PLACEBO COMPARATOR

Placebo oral tablet

Drug: Placebo Oral Tablet

Interventions

Sitagliptin DRUG

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

Also known as: Januvia

Part A; Part B; Part C

Placebo Oral Tablet DRUG

Part D

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

Albert Einstein College of Medicine CRC

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Dr. Rubina Heptulla
• Organization: Children's Hospital at Montefiore

rheptull@montefiore.org

718-920-7004

Study Officials

• Rubina Heptulla, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief of Pediatric Endocrinology & Diabetes

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 9, 2012
• Study Start: November 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 16, 2018
• Results First Posted: July 16, 2018

Record last verified: 2018-07

Locations

US (1)