This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Treatment jardiance
Sponsor Boehringer Ingelheim
Collaborator Eli Lilly and Company
Start date February 2015
End date September 2016
Trial size 720 participants
Trial identifier NCT02367131, 1245.98


Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Incidence of adverse drug reactions
time frame: up to 52 weeks

Secondary Outcomes

Change from baseline in HbA1c to the last- observation on treatment
time frame: up to 52 weeks
Change from baseline in Fasting plasma glucose to the last- observation on treatment
time frame: up to 52 weeks

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion criteria: Male and female elderly patients (age 65 and over) with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment and start taking JARDIANCE® Tablets within 3 months after launch in Japan Exclusion criteria:

Additional Information

Official title Post Marketing Surveillance in Japan on Drug Use of JARDIANCE® Tablets in Elderly Patients With Type 2 Diabetes Mellitus
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.