Treatment of Diabetes After Gastric Bypass With Sitagliptin (LAF33)

Blandine Laferrere

Status

Completed

Conditions

Type 2 Diabetes Mellitus

Treatments

Other: Placebo

Drug: Sitagliptin phosphate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01512797

0000048421 (Other Grant/Funding Number)

AAAO1107

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.