Trial Outcomes & Findings for Treatment of Diabetes After Gastric Bypass With Sitagliptin (NCT NCT01512797)
NCT ID: NCT01512797
Last Updated: 2019-01-22
Results Overview
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).
COMPLETED
NA
37 participants
Baseline and ~4 weeks
2019-01-22
Participant Flow
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.
37 participants were enrolled, however only 32 participated in study procedures and demographic information collection.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Diabetes After Gastric Bypass With Sitagliptin
Baseline characteristics by cohort
| Measure |
Sitagliptin Phosphate
n=16 Participants
100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks
Sitagliptin phosphate: 100 mg/day orally
|
Placebo
n=16 Participants
1 Placebo pill / day PO once a day for 4-5 weeks
Placebo: 1 Placebo Pill per day
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic Black
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
BMI
|
32.70 kg/m2
STANDARD_DEVIATION 5.22 • n=5 Participants
|
36.12 kg/m2
STANDARD_DEVIATION 7.69 • n=7 Participants
|
34.41 kg/m2
STANDARD_DEVIATION 6.69 • n=5 Participants
|
|
HbA1c
|
7.46 %
STANDARD_DEVIATION 0.78 • n=5 Participants
|
6.96 %
STANDARD_DEVIATION 0.70 • n=7 Participants
|
7.21 %
STANDARD_DEVIATION 0.77 • n=5 Participants
|
|
Time since Roux-en-Y gastric bypass surgery
|
5.56 years
STANDARD_DEVIATION 3.77 • n=5 Participants
|
5.57 years
STANDARD_DEVIATION 2.80 • n=7 Participants
|
5.56 years
STANDARD_DEVIATION 3.27 • n=5 Participants
|
|
Type 2 Diabetes Mellitus duration prior to Roux-en-Y gastric bypass surgery
|
12.9 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
12.9 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
12.9 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Type 2 Diabetes Mellitus remission duration prior to study
|
2.72 years
STANDARD_DEVIATION 3.10 • n=5 Participants
|
2.16 years
STANDARD_DEVIATION 2.74 • n=7 Participants
|
2.44 years
STANDARD_DEVIATION 2.89 • n=5 Participants
|
|
Maximum Weight before Roux-en-Y gastric bypass surgery
|
122.45 kg
STANDARD_DEVIATION 19.0 • n=5 Participants
|
132.89 kg
STANDARD_DEVIATION 24.23 • n=7 Participants
|
127.7 kg
STANDARD_DEVIATION 22.1 • n=5 Participants
|
|
Weight at Roux-en-Y gastric bypass
|
117.5 kg
STANDARD_DEVIATION 20.4 • n=5 Participants
|
130.23 kg
STANDARD_DEVIATION 24.6 • n=7 Participants
|
123.9 kg
STANDARD_DEVIATION 23.1 • n=5 Participants
|
|
Nadir weight after Roux-en-Y gastric bypass
|
73.51 kg
STANDARD_DEVIATION 17.52 • n=5 Participants
|
82.93 kg
STANDARD_DEVIATION 13.38 • n=7 Participants
|
78.22 kg
STANDARD_DEVIATION 16.06 • n=5 Participants
|
|
Current Weight
|
85.98 kg
STANDARD_DEVIATION 15.21 • n=5 Participants
|
95.82 kg
STANDARD_DEVIATION 19.71 • n=7 Participants
|
90.90 kg
STANDARD_DEVIATION 18.02 • n=5 Participants
|
|
Current weight loss since Roux-en-Y gastric bypass
|
31.53 kg
STANDARD_DEVIATION 11.90 • n=5 Participants
|
34.47 kg
STANDARD_DEVIATION 13.91 • n=7 Participants
|
33.00 kg
STANDARD_DEVIATION 12.82 • n=5 Participants
|
|
Weight regain from nadir weight
|
12.73 kg
STANDARD_DEVIATION 10.70 • n=5 Participants
|
12.96 kg
STANDARD_DEVIATION 10.94 • n=7 Participants
|
12.84 kg
STANDARD_DEVIATION 10.64 • n=5 Participants
|
|
Number of oral type 2 diabetes mellitus medications prior to Roux-en-Y gastric bypass
|
1.88 number of medications
STANDARD_DEVIATION 0.89 • n=5 Participants
|
1.75 number of medications
STANDARD_DEVIATION 0.93 • n=7 Participants
|
1.81 number of medications
STANDARD_DEVIATION 0.90 • n=5 Participants
|
|
Participants on insulin prior to RYGB
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Participants on insulin at time of study
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Total Cholesterol
|
172.0 mg/dL
STANDARD_DEVIATION 41.5 • n=5 Participants
|
151.78 mg/dL
STANDARD_DEVIATION 32.67 • n=7 Participants
|
161.1 mg/dL
STANDARD_DEVIATION 37.67 • n=5 Participants
|
|
Triglycerides
|
147.3 mg/dL
STANDARD_DEVIATION 123.9 • n=5 Participants
|
124.7 mg/dL
STANDARD_DEVIATION 50.2 • n=7 Participants
|
135.1 mg/dL
STANDARD_DEVIATION 90.6 • n=5 Participants
|
|
High-density lipoprotein
|
54.83 mg/dL
STANDARD_DEVIATION 15.21 • n=5 Participants
|
59.21 mg/dL
STANDARD_DEVIATION 29.39 • n=7 Participants
|
57.19 mg/dL
STANDARD_DEVIATION 23.58 • n=5 Participants
|
|
Low-density lipoprotein
|
89.18 mg/dL
STANDARD_DEVIATION 39.92 • n=5 Participants
|
76.79 mg/dL
STANDARD_DEVIATION 28.24 • n=7 Participants
|
82.24 mg/dL
STANDARD_DEVIATION 33.70 • n=5 Participants
|
|
Systolic blood pressure
|
124.8 mm Hg
STANDARD_DEVIATION 21.23 • n=5 Participants
|
119.1 mm Hg
STANDARD_DEVIATION 14.4 • n=7 Participants
|
122.23 mm Hg
STANDARD_DEVIATION 18.4 • n=5 Participants
|
|
Diastolic blood pressure
|
74.69 mm Hg
STANDARD_DEVIATION 12.26 • n=5 Participants
|
69.77 mm Hg
STANDARD_DEVIATION 11.05 • n=7 Participants
|
72.48 mm Hg
STANDARD_DEVIATION 11.79 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and ~4 weeksPopulation: All patients completed study in both arms.
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).
Outcome measures
| Measure |
Sitagliptin Phosphate
n=16 Participants
100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks
Sitagliptin phosphate: 100 mg/day orally
|
Placebo
n=16 Participants
1 Placebo pill / day PO once a day for 4-5 weeks
Placebo: 1 Placebo Pill per day
|
|---|---|---|
|
Change in Postprandial Glucose Levels After Mixed Meal Test
Pre-Intervention Fasting Glucose
|
7.10 mmol/L
Standard Deviation 1.74
|
6.52 mmol/L
Standard Deviation 1.21
|
|
Change in Postprandial Glucose Levels After Mixed Meal Test
Post-Intervention Fasting Glucose
|
6.44 mmol/L
Standard Deviation 1.25
|
6.39 mmol/L
Standard Deviation 1.23
|
|
Change in Postprandial Glucose Levels After Mixed Meal Test
Pre-Intervention 120 minute glucose
|
7.51 mmol/L
Standard Deviation 1.91
|
7.01 mmol/L
Standard Deviation 1.38
|
|
Change in Postprandial Glucose Levels After Mixed Meal Test
Post-Intervention 120 minute glucose
|
6.79 mmol/L
Standard Deviation 1.65
|
6.97 mmol/L
Standard Deviation 1.47
|
|
Change in Postprandial Glucose Levels After Mixed Meal Test
Pre-Intervention Average Glucose during MMT
|
8.55 mmol/L
Standard Deviation 1.95
|
8.12 mmol/L
Standard Deviation 1.14
|
|
Change in Postprandial Glucose Levels After Mixed Meal Test
Post-Intervention Average Glucose during MMT
|
7.84 mmol/L
Standard Deviation 1.47
|
7.86 mmol/L
Standard Deviation 1.04
|
PRIMARY outcome
Timeframe: Baseline and ~4 weeksGlucose 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.
Outcome measures
| Measure |
Sitagliptin Phosphate
n=16 Participants
100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks
Sitagliptin phosphate: 100 mg/day orally
|
Placebo
n=16 Participants
1 Placebo pill / day PO once a day for 4-5 weeks
Placebo: 1 Placebo Pill per day
|
|---|---|---|
|
Change in Area Under the Curve (AUC) Glucose Levels After Mixed Meal Test
Pre-Intervention Glucose AUC
|
8.31 mmol/L/min
Standard Deviation 1.92
|
7.96 mmol/L/min
Standard Deviation 1.20
|
|
Change in Area Under the Curve (AUC) Glucose Levels After Mixed Meal Test
Post-Intervention Glucose AUC
|
7.67 mmol/L/min
Standard Deviation 1.59
|
7.75 mmol/L/min
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Baseline and ~4 weeksSatiety 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."
Outcome measures
| Measure |
Sitagliptin Phosphate
n=16 Participants
100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks
Sitagliptin phosphate: 100 mg/day orally
|
Placebo
n=16 Participants
1 Placebo pill / day PO once a day for 4-5 weeks
Placebo: 1 Placebo Pill per day
|
|---|---|---|
|
Effect of Sitagliptin vs Placebo on Satiety in Patients With Type 2 Diabetes After Gastric Bypass Surgery
Pre-Intervention fasting satiety level
|
51.94 mm
Standard Deviation 87.40
|
49.06 mm
Standard Deviation 39.36
|
|
Effect of Sitagliptin vs Placebo on Satiety in Patients With Type 2 Diabetes After Gastric Bypass Surgery
Post-Intervention fasting satiety level
|
22.38 mm
Standard Deviation 22.03
|
58.50 mm
Standard Deviation 113.23
|
|
Effect of Sitagliptin vs Placebo on Satiety in Patients With Type 2 Diabetes After Gastric Bypass Surgery
Pre-Intervention 180 minute glucose
|
37.81 mm
Standard Deviation 40.95
|
50.50 mm
Standard Deviation 59.37
|
|
Effect of Sitagliptin vs Placebo on Satiety in Patients With Type 2 Diabetes After Gastric Bypass Surgery
Post-Intervention 180 minute glucose
|
43.69 mm
Standard Deviation 43.85
|
103.75 mm
Standard Deviation 198.35
|
SECONDARY outcome
Timeframe: 6 weeksSide 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.
Outcome measures
| Measure |
Sitagliptin Phosphate
n=16 Participants
100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks
Sitagliptin phosphate: 100 mg/day orally
|
Placebo
n=16 Participants
1 Placebo pill / day PO once a day for 4-5 weeks
Placebo: 1 Placebo Pill per day
|
|---|---|---|
|
Occurrence of Side Effects In Relation to Sitagliptin
Pre-Intervention Average Sigstad Score
|
2.15 units on Sigstad scale
Standard Deviation 1.97
|
5.58 units on Sigstad scale
Standard Deviation 3.41
|
|
Occurrence of Side Effects In Relation to Sitagliptin
Post-Intervention Average Sigstad Score
|
2.24 units on Sigstad scale
Standard Deviation 2.34
|
4.40 units on Sigstad scale
Standard Deviation 3.10
|
SECONDARY outcome
Timeframe: Pre-Intervention and Post-InterventionActive 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.
Outcome measures
| Measure |
Sitagliptin Phosphate
n=16 Participants
100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks
Sitagliptin phosphate: 100 mg/day orally
|
Placebo
n=16 Participants
1 Placebo pill / day PO once a day for 4-5 weeks
Placebo: 1 Placebo Pill per day
|
|---|---|---|
|
Active GLP-1
Change in Fasting Active GLP-1
|
1.45 pmol/L
Standard Deviation 2.59
|
-0.22 pmol/L
Standard Deviation 0.88
|
|
Active GLP-1
Change in Peak Active GLP-1
|
22.08 pmol/L
Standard Deviation 15.46
|
2.97 pmol/L
Standard Deviation 10.44
|
Adverse Events
Sitagliptin Phosphate
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Blandine Laferrere
Columbia University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place