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Study on Incidence of Diabetic Ketoacidosis Among Participants With Type 2 Diabetes Mellitus Treated With Sodium-glucose Co-transporter 2 (SGLT2) Inhibitors or Other Antihyperglycemic Agents

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ClinicalTrials.gov Identifier: NCT02636192
Recruitment Status : Completed
First Posted : December 21, 2015
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: No Intervention

Detailed Description:
This study will be an overall retrospective, observational, new-user cohort study using 4 large administrative claims databases in the US. Participants diagnosed with T2DM and initiated on SGLT2i or other AHAs (metformin, sulfonylureas (SU), thiazolidinediones (TZDs), DPP-4 inhibitors (DPP4i), GLP-1 agonists, insulin, and other AHAs) between April 1, 2013 and the end of claims data availability will be included in the study and will be estimated for incidence rates of DKA in the different AHA new-user groups.

Study Type : Observational
Actual Enrollment : 200000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence of Diabetic Ketoacidosis Among Patients With Type 2 Diabetes Mellitus Treated With SGLT2 Inhibitors or Other Antihyperglycemic Agents- A Retrospective, Observational, New-User Cohort Study Using 4 Administrative Claims Databases in the US
Actual Study Start Date : July 31, 2015
Actual Primary Completion Date : April 7, 2017
Actual Study Completion Date : April 7, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cohort 1
Cohort 1 included participants who were exposed to sodium-glucose co-transporter 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin and empagliflozin).
Drug: No Intervention
This is an observational study and participants did not receive any intervention in this study.

Cohort 2
Cohort 2 included participants who were exposed to other non-SGLT2 antihyperglycemic agents (AHA).
Drug: No Intervention
This is an observational study and participants did not receive any intervention in this study.




Primary Outcome Measures :
  1. Number of Participants with a recorded diagnosis of Diabetic Ketoacidosis (DKA) [ Time Frame: Day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636192


Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trials Janssen Research & Development, LLC

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02636192     History of Changes
Other Study ID Numbers: CR108054
RRA-15322 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by Janssen Research & Development, LLC:
Sodium-glucose co-transporter 2 inhibitors
Diabetes Mellitus, Type 2

Additional relevant MeSH terms:
Diabetic Ketoacidosis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Ketosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acidosis
Acid-Base Imbalance
Diabetes Complications
Hypoglycemic Agents
Physiological Effects of Drugs