CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 target
Drug / intervention
Incretin analogues +4 moredrug
Likely dose
Incretin analogues 1.8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02041234
NCT02041234Phase 4Completed
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Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes vs Best Medical Treatment

Khoo Teck Puat Hospital·interventional·Posted Jan 22, 2014·Updated Jun 23, 2022

In Brief

A Phase 4 clinical trial evaluating Roux-en-Y Gastric Bypass (RYGB), Incretin analogues, and 3 other interventions for Type II Diabetes in Subjects BMI 27 to 32. Completed, enrolled 40 participants across 1 site.

Detailed Summary

Investigators aim to show that Roux-en-Y Gastric Bypass (RYGB) is superior to best medical treatment in reaching well-defined treatment end points in Asian subjects of BMI 27-32 with type 2 Diabetes (DM2). Investigators also hope to show that successful RYGB will reduce resource utilization in the near term with similar projected reduction over the medium to long term.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType II Diabetes in Subjects BMI 27 to 32
CountriesSingapore
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 22, 2014
Enrollment StartFeb 1, 2014
Primary CompletionDec 1, 2020
Study CompletionJun 1, 2022
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 12.4 years ago

Interventions

Roux-en-Y Gastric Bypass (RYGB)procedure

Roux-en-Y Gastric Bypass (RYGB) as per standard surgical protocol, with a 30 cc gastric pouch, 50 cm biliopancreatic limb and 100cm gastrointestinal limb.

Incretin analoguesdrug

Incretin analogues: Liraglutide up to 1.8 mg daily

Xenicaldrug

Xenical: Up to 120 mg tds

SGLT2 inhibitorsdrug

SGLT2 inhibitors: Empagliflozin up to 25mg daily, Canagliflozin up to 300mg daily

DPP-4 Inhibitorsdrug

Sitagliptin up to 100 mg daily, Linagliptin up to 5mg daily