Randomized Trial Comparing Sitagliptin to Placebo in Closed Loop

NCT02328040 | Completed Phase 1 Results DMC

• 1 other identifier: 2013-330-000
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

There are many recent advances in insulin treatment of type 1 Diabetes Mellitus (T1DM), 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 glucose (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 mixed meal and its effects on insulin levels. The hormones that affect blood glucose as well as your sugar levels will be measured by a series of blood tests. We will also look for high 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) 50 mg and 100 mg dosages. You and the researchers will not know which dose you are taking at any single visit. We will first enroll 10 subjects with established type 1 Diabetes Mellitus for at least 1 year, between the ages of 18-30 years old. The first 10 patients will be evaluated for safety parameters such as ability to keep blood sugars \< 70 mg/dl for at least 70% of the time, no episode of severe hypoglycemia (low blood sugars) and so on. After this safety criteria is established, we will then recruit subjects between the ages of 14-19 yrs for the next phase of the study. A total of 17 subjects were enrolled into the study.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1; Closed loop; Artificial Pancreas; Insulin; Sitagliptin; Januvia

Outcome Measures

Primary Outcomes (1)

• Blood Glucose Measures in Subjects Treated With Sitagliptin, Compared to the Placebo

  Better targeted blood glucose levels in the CL setting in the treatment arm, Sitagliptin, compared to placebo (insulin monotherapy)

  18 Months

Secondary Outcomes (1)

• Measure of Glucagon Concentration in Subjects Treated With Sitagliptin, Compared to Placebo

  18 months

Study Arms (2)

Part A

PLACEBO COMPARATOR

Placebo and Insulin monotherapy via CL

Drug: Placebo and Insulin monotherapy via CL

Part B

ACTIVE COMPARATOR

Sitagliptin and insulin/novolog via CL

Drug: Sitagliptin and insulin/novolog via CL

Interventions

Placebo and Insulin monotherapy via CL DRUG

In the control arm patient receives a placebo pill with the closed loop with insulin/novolog (placebo and insulin/novolog via CL)

Part A

Sitagliptin and insulin/novolog via CL DRUG

In the treatment arm the participant receives a single dose of sitagliptin with closed loop with insulin/novolog (Sitagliptin and insulin/novolog via CL), Part B

Also known as: Januvia

Part B

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age of 14 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
• Medtronic: collaborator

Study Sites (1)

Albert Einstein College of Medicine CRC

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Interventions

Sitagliptin Phosphate; Insulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

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 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief of Pediatric Endocrinology

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: December 31, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 7, 2018
• Results First Posted: August 7, 2018

Record last verified: 2018-07

Locations

US (1)