Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to determine the effects of sitagliptin on glucose variability both after meals and overnight in adult patients with type 1 diabetes.

Detailed Description
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Improved post prandial glucose control with multiple daily injections of insulin in the DCCT study demonstrated significant reductions in microvascular complication. Similar to type 2 diabetes, patients with type 1 diabetes have a paradoxical increase in glucagon after meals which contribute to worsening post prandial glucose control. This proposed study is designed to determine if altering the glucagon axis by giving sitagliptin can improve glucose control in patients with type 1 diabetes.

Official Title
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Pilot Study Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Sitagliptin
* Drug: Sugar Pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female adult, aged 18 to 70 years Type 1 diabetes mellitus as established by medical history Current treatment with MDI or CSII therapy for at least 3 months prior to screening visit; and using the same insulin during the last 1 month HbA1c ≥ 8.5% Subjects should routinely practice at least 2-4 blood glucose measurements per day BMI ≤ 35 kg/m2 Subject must be able and willing to perform self-blood glucose monitoring and accept wearing a continuous glucose monitor for the total duration of the study Willing to complete a routine medical visits every 3 months Willing to complete a total of 7 phone visits Able to speak, read, and write English Exclusion Criteria: On oral, inhaled or pre-mixed insulin On Symlin BMI > 35 kg/m2 Pregnant or intends to become pregnant during the course of the study Severe unexplained hypoglycemia that required emergency treatment over the past 3 months History of hemoglobinopathies Diagnosis of anemia HbA1C greater than 12% Post-renal transplantation, currently undergoing dialysis, creatinine of >1.5mg/dl or a calculated creatinine clearance of <50 mL/min. Have extensive skin changes/diseases that inhibit wearing the sensor on normal skin Subjects who have a medical known allergy to adhesives Subjects who have an allergy to medication being used Currently participation in another investigational study protocol. Must have completed a previous study at least 30 days prior to being enrolled in this one Have any condition that, in the opinion of the Investigator, would interfere with their participation in the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sitagliptin<br>Patients will receive sitagliptin for 4 weeks and then cross over to sugar pill | Drug: Sitagliptin<br>* Sitagliptin 100mg tablet taken orally once daily for 4 weeks and then switch over to sugar pill taken daily for 4 weeks<br>* Other names: Januvia;|
| Placebo Comparator: Sugar pill<br>Subjects will receive sugar pill for 4 weeks and then cross over to active sitagliptin | Drug: Sugar Pill<br>* Sugar pill taken daily for 4 weeks and then switched over to active comparator of sitagliptin 100mg tablet taken daily for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this pilot study is to compare 24-hour blood glucose values (overnight and pre- and post- prandial glucoses) in adult subjects with type 1 diabetes receiving either sitagliptin or placebo |  | Assessment done at week 4 and week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine differences in fructosamine values |  | baseline, 4 and 8 weeks | 
| Time spent in hypoglycemic and hyperglycemic excursions recorded on the DexCom STS continuous glucose monitor (CGM) at 3 time periods throughout the study |  | Assessed at week 4 and week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 1 diabetes, glucose variability