Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes
NCT ID: NCT00978796
Last Updated: 2010-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2009-09-30
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Sitagliptin
Patients will receive sitagliptin for 4 weeks and then cross over to sugar pill
Sitagliptin
Sitagliptin 100mg tablet taken orally once daily for 4 weeks and then switch over to sugar pill taken daily for 4 weeks
Sugar pill
Subjects will receive sugar pill for 4 weeks and then cross over to active sitagliptin
Sugar Pill
Sugar pill taken daily for 4 weeks and then switched over to active comparator of sitagliptin 100mg tablet taken daily for 4 weeks
Interventions
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Sitagliptin
Sitagliptin 100mg tablet taken orally once daily for 4 weeks and then switch over to sugar pill taken daily for 4 weeks
Sugar Pill
Sugar pill taken daily for 4 weeks and then switched over to active comparator of sitagliptin 100mg tablet taken daily for 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Barbara Davis Center for Childhood Diabetes
Principal Investigators
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Satish Garg, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Samuel L Ellis, Pharm.D.
Role: PRINCIPAL_INVESTIGATOR
University of Colorado School of Pharmacy
Locations
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Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Countries
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References
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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.
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.
Other Identifiers
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Merck IISP-32888
Identifier Type: -
Identifier Source: org_study_id
NCT01227460
Identifier Type: -
Identifier Source: nct_alias