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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Sitagliptin phosphate
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment for this study took place from July 2012-July 2016. 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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
37 participants were enrolled, however only 32 participated in study procedures and demographic information collection.

Reporting Groups
  Description
Sitagliptin Phosphate

100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks

Sitagliptin phosphate: 100 mg/day orally

Placebo

1 Placebo pill / day PO once a day for 4-5 weeks

Placebo: 1 Placebo Pill per day


Participant Flow:   Overall Study
    Sitagliptin Phosphate   Placebo
STARTED   16   16 
COMPLETED   16   16 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sitagliptin Phosphate

100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks

Sitagliptin phosphate: 100 mg/day orally

Placebo

1 Placebo pill / day PO once a day for 4-5 weeks

Placebo: 1 Placebo Pill per day

Total Total of all reporting groups

Baseline Measures
   Sitagliptin Phosphate   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   16   32 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.2  (9.0)   58.4  (7.0)   56.3  (8.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      15  93.8%      14  87.5%      29  90.6% 
Male      1   6.3%      2  12.5%      3   9.4% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Caucasian      4  25.0%      4  25.0%      8  25.0% 
Hispanic White      5  31.3%      5  31.3%      10  31.3% 
Hispanic Black      2  12.5%      3  18.8%      5  15.6% 
African-American      5  31.3%      4  25.0%      9  28.1% 
BMI 
[Units: Kg/m2]
Mean (Standard Deviation)
 32.70  (5.22)   36.12  (7.69)   34.41  (6.69) 
HbA1c 
[Units: %]
Mean (Standard Deviation)
 7.46  (0.78)   6.96  (0.70)   7.21  (0.77) 
Time since Roux-en-Y gastric bypass surgery 
[Units: Years]
Mean (Standard Deviation)
 5.56  (3.77)   5.57  (2.80)   5.56  (3.27) 
Type 2 Diabetes Mellitus duration prior to Roux-en-Y gastric bypass surgery 
[Units: Years]
Mean (Standard Deviation)
 12.9  (11.0)   12.9  (9.3)   12.9  (10.0) 
Type 2 Diabetes Mellitus remission duration prior to study 
[Units: Years]
Mean (Standard Deviation)
 2.72  (3.10)   2.16  (2.74)   2.44  (2.89) 
Maximum Weight before Roux-en-Y gastric bypass surgery 
[Units: Kg]
Mean (Standard Deviation)
 122.45  (19.0)   132.89  (24.23)   127.7  (22.1) 
Weight at Roux-en-Y gastric bypass 
[Units: Kg]
Mean (Standard Deviation)
 117.5  (20.4)   130.23  (24.6)   123.9  (23.1) 
Nadir weight after Roux-en-Y gastric bypass 
[Units: Kg]
Mean (Standard Deviation)
 73.51  (17.52)   82.93  (13.38)   78.22  (16.06) 
Current Weight 
[Units: Kg]
Mean (Standard Deviation)
 85.98  (15.21)   95.82  (19.71)   90.90  (18.02) 
Current weight loss since Roux-en-Y gastric bypass 
[Units: Kg]
Mean (Standard Deviation)
 31.53  (11.90)   34.47  (13.91)   33.00  (12.82) 
Weight regain from nadir weight 
[Units: Kg]
Mean (Standard Deviation)
 12.73  (10.70)   12.96  (10.94)   12.84  (10.64) 
Number of oral type 2 diabetes mellitus medications prior to Roux-en-Y gastric bypass 
[Units: Number of medications]
Mean (Standard Deviation)
 1.88  (0.89)   1.75  (0.93)   1.81  (0.90) 
Participants on insulin prior to RYGB 
[Units: Participants]
Count of Participants
 10   10   20 
Participants on insulin at time of study 
[Units: Participants]
Count of Participants
 3   4   7 
Total Cholesterol 
[Units: mg/dL]
Mean (Standard Deviation)
 172.0  (41.5)   151.78  (32.67)   161.1  (37.67) 
Triglycerides 
[Units: mg/dL]
Mean (Standard Deviation)
 147.3  (123.9)   124.7  (50.2)   135.1  (90.6) 
High-density lipoprotein 
[Units: mg/dL]
Mean (Standard Deviation)
 54.83  (15.21)   59.21  (29.39)   57.19  (23.58) 
Low-density lipoprotein 
[Units: mg/dL]
Mean (Standard Deviation)
 89.18  (39.92)   76.79  (28.24)   82.24  (33.70) 
Systolic blood pressure 
[Units: Mm Hg]
Mean (Standard Deviation)
 124.8  (21.23)   119.1  (14.4)   122.23  (18.4) 
Diastolic blood pressure 
[Units: Mm Hg]
Mean (Standard Deviation)
 74.69  (12.26)   69.77  (11.05)   72.48  (11.79) 


  Outcome Measures

1.  Primary:   Change in Postprandial Glucose Levels After Mixed Meal Test   [ Time Frame: Baseline and ~4 weeks ]

2.  Primary:   Change in Area Under the Curve (AUC) Glucose Levels After Mixed Meal Test   [ Time Frame: Baseline and ~4 weeks ]

3.  Secondary:   Effect of Sitagliptin vs Placebo on Satiety in Patients With Type 2 Diabetes After Gastric Bypass Surgery   [ Time Frame: Baseline and ~4 weeks ]

4.  Secondary:   Occurrence of Side Effects In Relation to Sitagliptin   [ Time Frame: 6 weeks ]

5.  Secondary:   Active GLP-1   [ Time Frame: Pre-Intervention and Post-Intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Blandine Laferrere
Organization: Columbia University Medical Center
phone: 212-851-5562
e-mail: bbl14@columbia.edu



Responsible Party: Blandine Laferrere, Columbia University
ClinicalTrials.gov Identifier: NCT01512797     History of Changes
Other Study ID Numbers: AAAO1107
0000048421 ( Other Grant/Funding Number: Merck & Co., Inc )
First Submitted: January 13, 2012
First Posted: January 19, 2012
Results First Submitted: December 1, 2017
Results First Posted: February 23, 2018
Last Update Posted: February 23, 2018