Treatment of Diabetes After Gastric Bypass With Sitagliptin

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)

NCT01034111

Type 2 Diabetes

COMPLETED PHASE3

Dipeptidyl Peptidase-4 Inhibitor (Sitagliptin) Therapy in the Inpatients With Type 2 Diabetes

NCT01378117

Type 2 Diabetes Mellitus Hospitalization Hyperglycemia

COMPLETED PHASE4

Sitagliptin Dose Determination Study

NCT01530178

Diabetes Mellitus, Type 1

COMPLETED PHASE4

A Post Marketing Safety Study of Sitagliptin (JANUVIA®) (MK-0431-234)

NCT01354990

Diabetes Mellitus, Type 2

COMPLETED

The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects

NCT00659711

Type 2 Diabetes

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sitagliptin phosphate

100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks

Group Type ACTIVE_COMPARATOR

Sitagliptin phosphate

Intervention Type DRUG

100 mg/day orally

Placebo

1 Placebo pill / day PO once a day for 4-5 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

1 Placebo Pill per day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sitagliptin phosphate

100 mg/day orally

Intervention Type DRUG

Placebo

1 Placebo Pill per day

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Januvia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No