N/A
N=32
Treatment of Diabetes After Gastric Bypass With Sitagliptin
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01512797 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Change in Postprandial Glucose Levels After Mixed Meal Test — 7.10; 6.52; 6.44; 6.39 mmol/L — p=0.028
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sitagliptin phosphate (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Blandine Laferrere
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Postprandial Glucose Levels After Mixed Meal Test |
7.10; 6.52; 6.44; 6.39; 7.51; 7.01 | 0.028 sig |
| PRIMARY Change in Area Under the Curve (AUC) Glucose Levels After Mixed Meal Test |
8.31; 7.96; 7.67; 7.75 | — |
| SECONDARY Effect of Sitagliptin vs Placebo on Satiety in Patients With Type 2 Diabetes After Gastric Bypass Surgery |
51.94; 49.06; 22.38; 58.50; 37.81; 50.50 | — |
| SECONDARY Occurrence of Side Effects In Relation to Sitagliptin |
2.15; 5.58; 2.24; 4.40 | — |
| SECONDARY Active GLP-1 |
1.45; -0.22; 22.08; 2.97 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01512797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.