Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding

Part of paid clinical trials in Greenville, North Carolina.

Sponsor
East Carolina University
Study ID
NCT01597531
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    Liraglutide will be started at 0.6 mg injected subcutaneously daily for 1 week and then increased as tolerated to 1.2 mg and then a 1.8 mg daily.
  • Orlistat — DRUG
    Orlistat will be started initially at a dose of 60 mg taken with the evening meal. Additional doses will be added at breakfast or lunch every 1-2 weeks as tolerated. The patient will be advised to skip drug dosing if little or no fat is contained in the meal. Target dose will 60 mg three times a day and the patients will be advised to take a multivitamin 2 hours before or after Orlistat addition to ensure adequate nutrition.
  • Liraglutide + Orlistat — DRUG
    Liraglutide will be started at 0.6 mg injected subcutaneously daily for 1 week and then increased as tolerated to 1.2 mg and then a 1.8 mg daily. Patients not tolerating a higher dose will be allowed to remain on the lower dose as long they tolerate the lower. Following titration of Liraglutide to a maximum tolerated dose, Orlistat will be started initially at a dose of 60 mg taken with evening meal. Additional doses will be added at breakfast or lunch every 1-2 weeks as tolerated. The patient will be advised to skip drug dosing if little or no fat is contained in the meal. Target dose will 60 mg three times a day.

Study Details

The purpose of this study is to determine whether addition of 1 or 2 medicines after gastric banding can improve remission of type 2 diabetes.

Key Dates

Start date
Jun 30, 2012
Status verified
Jan 2018
Primary completion
Jun 30, 2014
Completion
Jun 30, 2014

Study Design

Enrollment
1 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Liraglutide only
  • Active Comparator: Orlistat only
  • Active Comparator: Liraglutide + Orlistat

Primary Outcome Measure

Type 2 diabetes remission [ Time Frame: baseline, 1 and 4 months post-randomization ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brody School of Medicine at East Carolina UniversityGreenvilleNorth Carolina28590-

Find similar trials in Greenville, NC

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Brody School of Medicine at East Carolina University· Greenville, NC

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