Treatment of Diabetes After Gastric Bypass With Sitagliptin (LAF33)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Change in Postprandial Glucose Levels in Patients with Type 2 Diabetes After Gastric Bypass Surgery [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]Sitagliptin 100 mg/d given for 6 weeks will lower postprandial glucose levels during a 200 kcal test meal compared to placebo in patients with type 2 diabetes after gastric bypass surgery.
- Change in Satiety in Patients with Type 2 Diabetes After Gastric Bypass Surgery [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]Sitagliptin 100 mg/d for 6 weeks will increase satiety more than placebo following a 200 kcal standard meal in patients with type 2 diabetes after gastric bypass surgery
- Occurrence of Side Effects In Relation to Sitagliptin [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Sitagliptin 100 mg/d for 6 weeks will not be associated with serious side effect and /or more side effects than placebo.
|Study Start Date:||July 2012|
|Study Completion Date:||August 2016|
|Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Sitagliptin phosphate
100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks
Drug: Sitagliptin phosphate
100 mg/day orally
Other Name: Januvia
Placebo Comparator: Placebo
1 Placebo pill / day PO once a day for 4-5 weeks
1 Placebo Pill per day
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512797
|United States, New York|
|New York Obesity Nutrition Research Center, Columbia University|
|New York, New York, United States, 10032|
|Principal Investigator:||Blandine Laferrere, MD||New York Obesity Nutrition Research Center|