NCT02636192

Brief Summary

The purpose of this study is to compare the incidence of diabetic ketoacidosis (DKA) among participants diagnosed with type 2 diabetes mellitus (T2DM) and pair-matched on exposure propensity scores for new use of any sodium-glucose co-transporter 2 inhibitors (SGLT2i) versus new use of various other antihyperglycemic agents (AHAs), combined as one group.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2017

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

1.7 years

First QC Date

December 17, 2015

Last Update Submit

April 12, 2017

Conditions

Diabetes Mellitus, Type 2

Keywords

Sodium-glucose co-transporter 2 inhibitorsDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with a recorded diagnosis of Diabetic Ketoacidosis (DKA)

    Day 1

Study Arms (2)

Cohort 1

Cohort 1 included participants who were exposed to sodium-glucose co-transporter 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin and empagliflozin).

Drug: No Intervention

Cohort 2

Cohort 2 included participants who were exposed to other non-SGLT2 antihyperglycemic agents (AHA).

Drug: No Intervention

Interventions

No InterventionDRUG

This is an observational study and participants did not receive any intervention in this study.

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants diagnosed with type 2 diabetes mellitus (T2DM) and initiated on sodium-glucose co-transporter 2 inhibitors (SGLT2i) or other Antihyperglycemic Agents (AHAs) were observed.

You may qualify if:

  • At least 1 antihyperglycemic agents (AHA) prescription (Rx) during the study period, between 4/1/2013 and 9/30/2014.
  • Diagnosed of type 2 diabetes mellitus
  • Enrollment history of at least 12 months
  • Having prescription drug coverage
  • Having no prescription of the index drug during the 6 months prior

You may not qualify if:

  • \- Participants who receive diagnosis of type1 diabetes mellitus (T1DM) and/or secondary diabetes mellitus (SDM) any time after index date.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Janssen Research & Development, LLC Clinical Trials

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2015

First Posted

December 21, 2015

Study Start

July 31, 2015

Primary Completion

April 7, 2017

Study Completion

April 7, 2017

Last Updated

April 13, 2017

Record last verified: 2017-04