Clinical trial NCT01512797: Treatment of Diabetes After Gastric Bypass With Sitagliptin
Official title: A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Assess Efficacy, Safety and Tolerability of Sitagliptin Phosphate 100 mg as Treatment for Recurrent, Persistent or Newly Diagnosed Type 2 Diabetes After Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Januvia
Sitagliptin
Diabetes
Gastric-Bypass
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-01-19
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether Januvia (sitagliptin phosphate 100mg) is safe and effective for the treatment of Type 2 Diabetes in patients who have had Gastric Bypass.

Detailed description: Januvia (sitagliptin phosphate 100mg) is an FDA approved medication for the treatment of Type 2 Diabetes. Sitagliptin works by inhibiting the Dipeptidyl peptidase-4 enzyme, resulting in increased active glucagon-like peptide-1 (GLP-1) levels. GLP-1 is an incretin which increases post-prandial insulin secretion. Because Gastric Bypass has also been shown to increase GLP-1 levels, this study seeks to determine the additional effect of DDP-4 inhibition on glucose control in patients who have elevated incretin levels post Gastric Bypass. The study will also assess if Januvia (Sitagliptin phosphate) is safe and well tolerated in patients after Gastric Bypass.

Recruitment and data collection for this study was started at St. Luke's Hospital in New York, NY and later moved to Columbia University Medical Center in New York, NY.

Eligibility criteria: Inclusion Criteria:

* Must be a resident of the NYC metropolitan area or be able to come for emergency unscheduled and regular weekly meetings in Manhattan.
* HbA1c ≥ 6.5% and ≤ 8.5 % or a fasting glucose ≥ 126 mg/dL or a random glucose ≥ 200 mg/dL at least 12 months after GBP surgery confirmed by central laboratory.
* Subject is capable and willing to give informed consent.
* Subject is otherwise in good general health, based on medical history and physical examination.
* Subject is a non smoker for at least 6 months prior to study start
* Female subjects of child bearing potential must use oral, injected or implanted hormonal methods of contraception from at least the commencement of their last normal period prior to the first administration of the challenge agent. Subjects using hormonal contraception should use a barrier method in addition from the first administration of challenge agent until their next normal period following the end of the study.

Exclusion Criteria:

* History of type 1 diabetes
* Female subject is pregnant or breastfeeding.
* Recent (\< 30 days) or simultaneous participation in another clinical trial.
* Any situation that can compromise the study, including serious illness or a predictable lack of cooperation from the subject.

Primary outcomes:
measure: Change in Postprandial Glucose Levels After Mixed Meal Test
timeFrame: Baseline and ~4 weeks
measure: Change in Area Under the Curve (AUC) Glucose Levels After Mixed Meal Test
timeFrame: Baseline and ~4 weeks
Secondary outcomes:
measure: Effect of Sitagliptin vs Placebo on Satiety in Patients With Type 2 Diabetes After Gastric Bypass Surgery
timeFrame: Baseline and ~4 weeks
measure: Occurrence of Side Effects In Relation to Sitagliptin
timeFrame: 6 weeks
measure: Active GLP-1
timeFrame: Pre-Intervention and Post-Intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Obesity Nutrition Research Center, Columbia University
state: New York
Study officials:
affiliation: New York Obesity Nutrition Research Center
name: Blandine Laferrere, MD
role: PRINCIPAL_INVESTIGATOR
References: