CARAT: Canagliflozin vs. Placebo for Post Bariatric Patients With Persistent Type 2 Diabetes

NCT02912455 | Terminated Phase 4 Results

• 1 other identifier: 16-574
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized clinical trial for patients with recurrent type 2 diabetes post-gastric bypass surgery that will compare a 6 month course of canagliflozin monotherapy vs. placebo on clinical outcomes of type 2 diabetes.

Conditions

Diabetes Mellitus, Type 2; Obesity

Keywords

Post-Bariatric Surgery; hemoglobin A1c protein, human

Outcome Measures

Primary Outcomes (1)

• Change at Six Months Versus Baseline in Hemoglobin A1c Value (%)

  The change in hemoglobin A1c from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery

  6 months

Secondary Outcomes (16)

• Change in Fasting Glucose From Randomization

  6 months

• Change in Body Weight at Six Months Compared to Baseline

  6 months

• Change in Total Cholesterol

  6 months

• Change in Diastolic Blood Pressure at Six Months Compared to Baseline

  6 months

• Change in Adiponectin Levels at 6 Months Compared to Randomization

  6 months

Study Arms (2)

Study Drug (canagliflozin)

ACTIVE COMPARATOR

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

Drug: canagliflozin

Placebo

PLACEBO COMPARATOR

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Drug: Placebo (for canagliflozin)

Interventions

canagliflozin DRUG

encapsulated (gelatin capsule).

Also known as: Invokana

Study Drug (canagliflozin)

Placebo (for canagliflozin) DRUG

encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post Roux-n-Y gastric bypass (RYGB) surgery and sleeve gastrectomy (SG) patients who underwent surgery \>1 and \<15 years ago in the Cleveland surrounding area
• Age 20-75 years of age
• Type II Diabetes Mellitus (D2M) diagnosis (history, medication usage, biochemical criteria) prior to and after surgery; after surgery, defined by a single HbA1c of greater or equal to 6.5% at consent and screening.
• Metformin patients must have an HbA1c greater than or equal to 6.5% but less than or equal to 10% at randomization; for diet controlled patients (i.e. not on any T2D medication), HbA1c must be greater than or equal to 6.5% at randomization.
• Patient reporting of improvement in T2D status or objective improvements in T2D status at any time post-surgery.
• estimated glomerular filtration rate (eGFR) ≥ 60mL/min prior to randomization
• Has the ability and willingness to provide informed consent.
• Is able to understand the options and to comply with the requirements of each program
• Female subject agrees to have a serum pregnancy test at screening. A negative serum pregnancy test result is required prior to randomization.
• Female patients must agree to use a reliable method of contraception for 6 months or duration of intervention
• Patients taking an anti-diabetic medication, except insulin, are eligible and must agree to washout for 8 weeks prior to the randomization visit.

You may not qualify if:

• Type 1 diabetes indicated by history of diabetic ketoacidosis and lack of remission in response to bariatric surgery
• Other post bariatric procedures (banding, duodenal switch, biliopancreatic diversion)
• Current use of insulin.
• End organ diabetic complications (renal failure, cardiomyopathy, severe neuropathy/foot ulcers)
• Documented severe or unstable depression/anxiety or eating disorder that would not enable patient to adhere to anti-diabetic treatment
• Clinical contraindications to use canagliflozin, i.e., history of bladder cancer, Child-Pugh class C

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Dr. Sangeeta Kashyap
• Organization: Cleveland Clinic

kashyas@ccf.org

(216) 445-2679

Study Officials

• Sangeeta Kashyap, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 23, 2016
• Study Start: January 5, 2017
• Primary Completion: July 19, 2018
• Study Completion: July 19, 2018
• Last Updated: November 20, 2020
• Results First Posted: June 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)