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
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Drug: Januvia (Sitagliptin phosphate)
Other: Placebo

Study Type: Interventional
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 Surgery

Resource links provided by NLM:


Further study details as provided by New York Obesity and Nutrition Research Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 42
Study Start Date: July 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Januvia
100 mg/day Januvia
Drug: Januvia (Sitagliptin phosphate)
100 mg/day orally
Placebo Comparator: Placebo
1 Placebo pill / day
Other: Placebo
1 Placebo Pill per day

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512797

Contacts
Contact: Margaret Sala (212) 523-3503 msala@chpnet.org
Contact: Carolina Espinosa, MS (212) 523-3581 cespinosa@chpnet.org

Locations
United States, New York
New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center Recruiting
New York, New York, United States, 10025
Contact: Carolina Espinosa, MS    212-523-3581    cespinosa@chpnet.org   
Principal Investigator: Blandine Laferrere, MD         
Sponsors and Collaborators
Blandine Laferrere, MD
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Blandine Laferrere, MD New York Obesity Nutrition Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Blandine Laferrere, MD, Associate Professor of Medicine, St. Luke's-Roosevelt Hospital Center, Columbia University, New York Obesity and Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01512797     History of Changes
Other Study ID Numbers: Laf33
Study First Received: January 13, 2012
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by New York Obesity and Nutrition Research Center:
Januvia
Sitagliptin
Diabetes
Gastric-Bypass

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014