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Treatment of Diabetes After Gastric Bypass With Sitagliptin (LAF33)

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ClinicalTrials.gov Identifier: NCT01512797
Recruitment Status : Completed
First Posted : January 19, 2012
Results First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Blandine Laferrere, Columbia University

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Sitagliptin phosphate Other: Placebo Not Applicable

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.

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
Other: Placebo
1 Placebo Pill per day



Primary Outcome Measures :
  1. Change in Postprandial Glucose Levels After Mixed Meal Test [ Time Frame: Baseline and ~4 weeks ]
    Glucose levels were measured in study participants while fasting and periodically over 3 hours after drinking a 200 kcal mixed meal test, before and after intervention (Sitagliptin or Placebo).

  2. Change in Area Under the Curve (AUC) Glucose Levels After Mixed Meal Test [ Time Frame: Baseline and ~4 weeks ]
    Glucose levels were measured in study participants while fasting and periodically over 3 hours after drinking a 200 kcal mixed meal test, before and after intervention (Sitagliptin or Placebo). AUC was measured by trapezoidal method.


Secondary Outcome Measures :
  1. Effect of Sitagliptin vs Placebo on Satiety in Patients With Type 2 Diabetes After Gastric Bypass Surgery [ Time Frame: Baseline and ~4 weeks ]
    Satiety levels were measured in study participants while they were fasting and periodically over a three hour period after drinking a 200 kcal meal drink, before and after intervention via a Visual Analog Scale. Participants were asked to mark on a 0 to 150 millimeter scale their response to the following question: "How full do you feel right now?" with lower scores indicating "not full at all" and higher scores indicating "extremely full."

  2. Occurrence of Side Effects In Relation to Sitagliptin [ Time Frame: 6 weeks ]
    Side effects to Sitagliptin or Placebo were measured in study participants via Sigstad score questionnaire, while fasting and periodically during a 3 hour period after drinking a 200 kcal meal drink, before and after intervention. The Sigstad scoring system is based on the participants report of the occurrence of 16 symptoms suggestive of the dumping syndrome. Each symptom is given a different score. For example, desire to sit down (+4), breathlessness (+3), dizziness (+2), nausea (+1), vomiting (-4) etc.The scale can range from -5 to 34. Scores greater than or equal to 7, after glucose intake, are considered diagnostic of dumping syndrome.

  3. Active GLP-1 [ Time Frame: Pre-Intervention and Post-Intervention ]
    Active GLP-1 (Fasting and during a Mixed Meal Test). The Change in Fasting Active GLP-1 refers to the change in fasting active GLP-1 from pre-intervention time point to post-intervention time point. The Change in Peak Active GLP-1 refers to the change in the peak active GLP-1 level from the pre-intervention time point to post-intervention time point.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512797


Locations
United States, New York
New York Obesity Nutrition Research Center, Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Blandine Laferrere
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Blandine Laferrere, MD New York Obesity Nutrition Research Center

Additional Information:
Responsible Party: Blandine Laferrere, Associate Professor of Medicine, Columbia University, Columbia University
ClinicalTrials.gov Identifier: NCT01512797     History of Changes
Other Study ID Numbers: AAAO1107
0000048421 ( Other Grant/Funding Number: Merck & Co., Inc )
First Posted: January 19, 2012    Key Record Dates
Results First Posted: February 23, 2018
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Blandine Laferrere, Columbia University:
Januvia
Sitagliptin
Diabetes
Gastric-Bypass

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