Metformin And Cardiovascular Effectiveness vs SGLT2 (MACES)

NCT03627039 | Unknown FDA Drug

• 1 other identifier: 123
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to compare the effectiveness of sodium glucose co-transporter 2 (SGLT2) inhibitors relative to metformin for reducing subsequent cardiovascular events in patients with type 2 diabetes mellitus. The investigators will conduct a population-based, new-user, longitudinal-cohort study using a nationwide US commercial insurance claims database. The investigators will compare adults with diabetes mellitus type 2 over the age of 18 who were newly prescribed an SGLT2 inhibitor or metformin between March 29, 2013 (date of US approval of first SGLT2) and January 1st, 2017 (most recent available data). Patients with diabetes mellitus type 2 will be identified using the International Classification of Diseases, Ninth Revision (ICD-9) and ICD-10 codes. Cohort entry date will be the date of the first prescription for an SGLT2 or metformin. New users of SGLT2 or metformin will be defined as those without a prior prescription for either class of medications, or any other medication for diabetes, in the preceding 180 days.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Cardiovascular composite (stroke, myocardial infarction, heart failure)

  The outcome will be identified using ICD9 and ICD10 codes and reported as rates of acute myocardial infarction, heart failure, stroke (they will only be analyzed individually if there are sufficient number of one of the events defined as \> 30 events)

  Follow-up will begin one day after cohort entry and continue until medication discontinuation, study outcome, or no further data. Most patients will have 200 days of follow up

Secondary Outcomes (6)

• Harms: Hypoglycemia

  Follow-up will begin one day after cohort entry and continue until medication discontinuation, study outcome, or no further data. Most patients will have 200 days of follow up

• Harms: diabetic ketoacidosis

  Follow-up will begin one day after cohort entry and continue until medication discontinuation, study outcome, or no further data. Most patients will have 200 days of follow up

• Harms: lactic acidosis

  Follow-up will begin one day after cohort entry and continue until medication discontinuation, study outcome, or no further data. Most patients will have 200 days of follow up

• Harms: Acute kidney injury

  Follow-up will begin one day after cohort entry and continue until medication discontinuation, study outcome, or no further data. Most patients will have 200 days of follow up

• Harms: Genital infection

  Follow-up will begin one day after cohort entry and continue until medication discontinuation, study outcome, or no further data. Most patients will have 200 days of follow up

Other Outcomes (1)

• Tracer outcomes

  Follow-up will begin one day after cohort entry and continue until medication discontinuation, study outcome, or no further data. Most patients will have 200 days of follow up

Study Arms (1)

Truven

NOTE: In the case there are not enough patients/events data will be included from other databases (e.g., Optum, Medicare)

Drug: SGLT2; Drug: Metformin

Interventions

SGLT2 DRUG

All SGLT2 medications approved prior to 2017 will be included (Canagliflozin, empagliflozin, dapagliflozin (all doses, all of the medications are oral)

Also known as: Canagliflozin, empagliflozin, dapagliflozin (all doses, all of the medications are oral)

Truven

Metformin DRUG

Metformin is the main comparator of interest. In a secondary analysis GLP1 will be the comparator

Also known as: All doses will be included. Metformin is an oral medication.

Truven

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will conduct a population-based, new-user, longitudinal-cohort study using the nationwide US commercial insurance claims database. This database provides patient demographics and longitudinal, individual-level data on healthcare utilization, inpatient and outpatient diagnoses, diagnostic tests, clinical procedures, outpatient laboratory results, and pharmacy dispensing of drugs.

You may qualify if:

• \- all patients newly prescribed an SGLT2 or metformin between March 29, 2013 to January 1st, 2017 with at least 6 months of continuous enrollment (1 year in a sensitivity analysis)

You may not qualify if:

• age \< 18 years
• previous use of any diabetes medication
• lack of a diagnosis of type 2 diabetes mellitus
• history of malignant neoplasm
• dialysis
• type 1 diabetes

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Division of Pharmacoepidemiology and Pharmacoeconomics

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Canagliflozin; empagliflozin; dapagliflozin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 13, 2018
• Study Start: September 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

US (1)