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Phase 4 N=8 Randomized Single-blind Treatment

Sitagliptin Dose Determination Study

Diabetes Mellitus, Type 1

Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Better Targeted Blood Glucose Levels — 184.1; 179.4; 153.6; 181.5 mg/dl — p=0.003

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Sitagliptin (Drug); Placebo Oral Tablet (Drug)
Age
Pediatric, Adult · 13+ yrs
Sex
All
Sponsor
Albert Einstein College of Medicine
Primary completion
Mar 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Better Targeted Blood Glucose Levels
184.1; 179.4; 153.6; 181.5 0.003 sig

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01530178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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