Clinical trial NCT00978796: Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes
Official title: Pilot Study Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Keywords: Diabetes Mellitus
Type 1 diabetes
glucose variability
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2009-09-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Assessment done at week 4 and week 8
Secondary outcomes:
measure: Determine differences in fructosamine values
timeFrame: baseline, 4 and 8 weeks
measure: Time spent in hypoglycemic and hyperglycemic excursions recorded on the DexCom STS continuous glucose monitor (CGM) at 3 time periods throughout the study
timeFrame: Assessed at week 4 and week 8
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Satish Garg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado School of Pharmacy
name: Samuel L Ellis, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellis SL, Moser EG, Snell-Bergeon JK, Rodionova AS, Hazenfield RM, Garg SK. Effect of sitagliptin on glucose control in adult patients with Type 1 diabetes: a pilot, double-blind, randomized, crossover trial. Diabet Med. 2011 Oct;28(10):1176-81. doi: 10.1111/j.1464-5491.2011.03331.x.
citation: Garg SK, Moser EG, Bode BW, Klaff LJ, Hiatt WR, Beatson C, Snell-Bergeon JK. Effect of sitagliptin on post-prandial glucagon and GLP-1 levels in patients with type 1 diabetes: investigator-initiated, double-blind, randomized, placebo-controlled trial. Endocr Pract. 2013 Jan-Feb;19(1):19-28. doi: 10.4158/EP12100.OR.