Treatment of Diabetes After Gastric Bypass With Sitagliptin
LAF33
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
2 other identifiers
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes-mellitus
Started Jul 2012
Longer than P75 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2012
CompletedFirst Posted
Study publicly available on registry
January 19, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
February 23, 2018
CompletedJanuary 22, 2019
January 1, 2019
4.1 years
January 13, 2012
December 1, 2017
January 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Postprandial Glucose Levels After Mixed Meal Test
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).
Baseline and ~4 weeks
Change in Area Under the Curve (AUC) Glucose Levels After Mixed Meal Test
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.
Baseline and ~4 weeks
Secondary Outcomes (3)
Effect of Sitagliptin vs Placebo on Satiety in Patients With Type 2 Diabetes After Gastric Bypass Surgery
Baseline and ~4 weeks
Occurrence of Side Effects In Relation to Sitagliptin
6 weeks
Active GLP-1
Pre-Intervention and Post-Intervention
Study Arms (2)
Sitagliptin phosphate
ACTIVE COMPARATOR100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks
Placebo
PLACEBO COMPARATOR1 Placebo pill / day PO once a day for 4-5 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Blandine Laferrerelead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
New York Obesity Nutrition Research Center, Columbia University
New York, New York, 10032, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study of short duration, designed as proof of concept. Absorption of sitagliptin may have been variable amongst subjects. The groups were small and the data cannot be extrapolated to a larger group of individuals with wide range of diabetes control.
Results Point of Contact
- Title
- Dr. Blandine Laferrere
- Organization
- Columbia University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Blandine Laferrere, MD
New York Obesity Nutrition Research Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Medicine, Columbia University
Study Record Dates
First Submitted
January 13, 2012
First Posted
January 19, 2012
Study Start
July 1, 2012
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
January 22, 2019
Results First Posted
February 23, 2018
Record last verified: 2019-01