Treatment of Diabetes After Gastric Bypass With Sitagliptin

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by New York Obesity and Nutrition Research Center
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Blandine Laferrere, MD, New York Obesity and Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01512797
First received: January 13, 2012
Last updated: April 30, 2013
Last verified: April 2013

January 13, 2012
April 30, 2013
July 2012
April 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01512797 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Treatment of Diabetes After Gastric Bypass With Sitagliptin
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 Surgery

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Januvia (Sitagliptin phosphate)
    100 mg/day orally
  • Other: Placebo
    1 Placebo Pill per day
  • Active Comparator: Januvia
    100 mg/day Januvia
    Intervention: Drug: Januvia (Sitagliptin phosphate)
  • Placebo Comparator: Placebo
    1 Placebo pill / day
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
April 2015
April 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Margaret Sala (212) 523-3503 msala@chpnet.org
Contact: Carolina Espinosa, MS (212) 523-3581 cespinosa@chpnet.org
United States
 
NCT01512797
Laf33
Yes
Blandine Laferrere, MD, New York Obesity and Nutrition Research Center
Blandine Laferrere, MD
Merck Sharp & Dohme Corp.
Principal Investigator: Blandine Laferrere, MD New York Obesity Nutrition Research Center
New York Obesity and Nutrition Research Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP