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Randomized Trial Comparing Sitagliptin to Placebo in Closed Loop

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ClinicalTrials.gov Identifier: NCT02328040
Recruitment Status : Completed
First Posted : December 31, 2014
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Rubina Heptulla, Albert Einstein College of Medicine

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Placebo and Insulin monotherapy via CL Drug: Sitagliptin and insulin/novolog via CL Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blinded, Randomized, Controlled Paired Trial Comparing Sitagliptin to Placebo in Closed Loop.
Study Start Date : September 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Part A
Placebo and Insulin monotherapy via CL
Drug: Placebo and Insulin monotherapy via CL
In the control arm patient receives a placebo pill with the closed loop with insulin/novolog (placebo and insulin/novolog via CL)

Active Comparator: Part B
Sitagliptin and insulin/novolog via CL
Drug: Sitagliptin and insulin/novolog via CL
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
Other Name: Januvia




Primary Outcome Measures :
  1. Blood Glucose Measures in Subjects Treated With Sitagliptin, Compared to the Placebo [ Time Frame: 18 Months ]
    Better targeted blood glucose levels in the CL setting in the treatment arm, Sitagliptin, compared to placebo (insulin monotherapy)


Secondary Outcome Measures :
  1. Measure of Glucagon Concentration in Subjects Treated With Sitagliptin, Compared to Placebo [ Time Frame: 18 months ]
    Serum glucagon concentrations were measured in the CL setting in the treatment arm, sitagliptin, compared to the placebo (Insulin monotherapy)



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Ages Eligible for Study:   14 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of 14 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 Known allergy to Januvia-

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): NCT02328040


Locations
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United States, New York
Albert Einstein College of Medicine CRC
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
Medtronic
Investigators
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Principal Investigator: Rubina Heptulla, MD Albert Einstein College of Medicine
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Responsible Party: Rubina Heptulla, Division Chief of Pediatric Endocrinology, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT02328040    
Other Study ID Numbers: 2013-330-000
First Posted: December 31, 2014    Key Record Dates
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018
Last Verified: July 2018
Keywords provided by Rubina Heptulla, Albert Einstein College of Medicine:
Diabetes Mellitus, Type 1
Closed loop
Artificial Pancreas
Insulin
Sitagliptin
Januvia
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Sitagliptin Phosphate
Insulin Aspart
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