Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 0000048421 | Other Grant/Funding Number | Merck & Co., Inc |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin phosphate | Active Comparator | 100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks |
|
| Placebo | Placebo Comparator | 1 Placebo pill / day PO once a day for 4-5 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin phosphate | Drug | 100 mg/day orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Sitagliptin vs Placebo on Satiety in Patients With Type 2 Diabetes After Gastric Bypass Surgery | 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." |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Blandine Laferrere, MD | New York Obesity Nutrition Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Obesity Nutrition Research Center, Columbia University | New York | New York | 10032 | United States |
Not provided
| Label | URL |
|---|---|
| New York Obesity Nutrition Research Center | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
37 participants were enrolled, however only 32 participated in study procedures and demographic information collection.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin Phosphate | 100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks Sitagliptin phosphate: 100 mg/day orally |
| FG001 | Placebo | 1 Placebo pill / day PO once a day for 4-5 weeks Placebo: 1 Placebo Pill per day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin Phosphate | 100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks Sitagliptin phosphate: 100 mg/day orally |
| BG001 | Placebo | 1 Placebo pill / day PO once a day for 4-5 weeks Placebo: 1 Placebo Pill per day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All patients completed study in both arms. | Posted | Mean | Standard Deviation | mmol/L | Baseline and ~4 weeks |
|
Over 6 weeks (the time period a participant was involved in the study).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitagliptin Phosphate | 100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks Sitagliptin phosphate: 100 mg/day orally |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Blandine Laferrere | Columbia University Medical Center | 212-851-5562 | bbl14@columbia.edu |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | 1 Placebo Pill per day |
|
| Baseline and ~4 weeks |
| Occurrence of Side Effects In Relation to Sitagliptin | 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. | 6 weeks |
| Active GLP-1 | 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. | Pre-Intervention and Post-Intervention |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| HbA1c | Mean | Standard Deviation | % |
|
| Time since Roux-en-Y gastric bypass surgery | Mean | Standard Deviation | years |
|
| Type 2 Diabetes Mellitus duration prior to Roux-en-Y gastric bypass surgery | Mean | Standard Deviation | years |
|
| Type 2 Diabetes Mellitus remission duration prior to study | Mean | Standard Deviation | years |
|
| Maximum Weight before Roux-en-Y gastric bypass surgery | Mean | Standard Deviation | kg |
|
| Weight at Roux-en-Y gastric bypass | Mean | Standard Deviation | kg |
|
| Nadir weight after Roux-en-Y gastric bypass | Mean | Standard Deviation | kg |
|
| Current Weight | Mean | Standard Deviation | kg |
|
| Current weight loss since Roux-en-Y gastric bypass | Mean | Standard Deviation | kg |
|
| Weight regain from nadir weight | Mean | Standard Deviation | kg |
|
| Number of oral type 2 diabetes mellitus medications prior to Roux-en-Y gastric bypass | Mean | Standard Deviation | number of medications |
|
| Participants on insulin prior to RYGB | Count of Participants | Participants |
|
| Participants on insulin at time of study | Count of Participants | Participants |
|
| Total Cholesterol | Mean | Standard Deviation | mg/dL |
|
| Triglycerides | Mean | Standard Deviation | mg/dL |
|
| High-density lipoprotein | Mean | Standard Deviation | mg/dL |
|
| Low-density lipoprotein | Mean | Standard Deviation | mg/dL |
|
| Systolic blood pressure | Mean | Standard Deviation | mm Hg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mm Hg |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | mmol/L/min | Baseline and ~4 weeks |
|
|
|
| Secondary | Effect of Sitagliptin vs Placebo on Satiety in Patients With Type 2 Diabetes After Gastric Bypass Surgery | 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." | Posted | Mean | Standard Deviation | mm | Baseline and ~4 weeks |
|
|
|
| Secondary | Occurrence of Side Effects In Relation to Sitagliptin | 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. | Posted | Mean | Standard Deviation | units on Sigstad scale | 6 weeks |
|
|
|
| Secondary | Active GLP-1 | 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. | Posted | Mean | Standard Deviation | pmol/L | Pre-Intervention and Post-Intervention |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Placebo | 1 Placebo pill / day PO once a day for 4-5 weeks Placebo: 1 Placebo Pill per day | 0 | 16 | 0 | 16 | 0 | 16 |
Not provided
Not provided
| D011719 |
| Pyrazines |
| Pre-Intervention 180 minute glucose |
|
| Post-Intervention 180 minute glucose |
|