This trial is active, not recruiting.

Conditions diabetes mellitus, type 2, diabetes mellitus
Treatment dmr procedure (fractyl)
Sponsor Fractyl Laboratories, Inc.
Start date January 2015
End date January 2017
Trial size 50 participants
Trial identifier NCT02413567, C-20000A


The purpose of this study is to evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR) Procedure for the treatment of Type 2 Diabetes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Subjects receive the endoscopic DMR procedure in this arm
dmr procedure (fractyl)
Endoscopic procedure

Primary Outcomes

Glycated Hemoglobin
time frame: 24 weeks post-procedure
Device or procedure related Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
time frame: 24 weeks post-procedure
Number of hypo-glycemic events (blood glucose level of < 56 mg/dL (3.1 mmol/L) or requiring 3rd party assistance)
time frame: 24 weeks

Eligibility Criteria

Male or female participants from 28 years up to 75 years old.

Inclusion Criteria: - 28 -75 years of age - Diagnosed with Type 2 Diabetes for less than 10 years - HbA1c of 7.5 - 10.0% (59-86 mmol/mol) - BMI ≥ 24 and ≤ 40 kg/m2 Exclusion Criteria: - Diagnosed with Type 1 Diabetes or with a history of ketoacidosis - Probable insulin production failure, defined as fasting C Peptide serum <1 ng/mL (333pmol/l) - Current use of Insulin - Use of GLP-1 analogues - Active and uncontrolled GERD defined as grade III esophagitis or greater - Upper gastro-intestinal conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia

Additional Information

Official title Evaluation of Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Fractyl Laboratories, Inc..