Clinical trial NCT02537834: Tofogliflozin GLP-1 Analogue Combination Trial
Official title: An Open-Label, Multicenter Study to Evaluate 52-Week Long-Term Safety, Tolerability and Efficacy of Tofogliflozin With Glucagon-like Peptide-1(GLP-1) Analogue Treatment In Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Kowa Company, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2015-09-02
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label, multicenter study to evaluate 52-week long-term safety, tolerability and efficacy of Tofogliflozin with GLP-1 analogue treatment in type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* The subject aged from 20 to 75 years old with type 2 diabetes mellitus(T2DM)
* The subject with hemoglobin A1c ≧7.5% - \<10.5 %
* The subject who has been receiving a stable dose and regimen of GLP-1 analogue over 8 weeks before Screening test

Exclusion Criteria:

* The subject with type 1 diabetes mellitus
* The subject with Pregnancy or lactation
* The subject with Fasting Plasma Glucose ≧ 270 mg/dl
* The subject with history of metabolic acidosis, including diabetic ketoacidosis ,within 1 year prior to screening
* The subject with myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months
* The subject with serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women
* The subject with aspartate aminotransferase(AST) or alanine aminotransferase(ALT) ≧ 2.5 times the upper limit of the reference range at the central laboratory test facility
* The subject has received treatment with another investigational product or non-approved drug 3 months before screening
* The subject with history of Tofogliflozin therapy
* The subject with estimated glomerular filtration rate of \<30 mL/min/1.73 m\^2
* The subject who frequently experiencing orthostatic hypotension
* The subject systolic blood pressure of ≧ 180 or mmHg of diastolic blood pressure of ≧ 100 mmHg
* The subject required a change in the dosing regiment for the following drugs within 4 weeks before screening : Lipid-lowering drug , Antihypertensive drug, Thyroid hormone drug , Uric acid lowering drug

Primary outcomes:
measure: Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction
timeFrame: baseline and Week 52
measure: Change from Baseline in HbA1c at 52 weeks
timeFrame: Week 52
Secondary outcomes:
measure: Change in Fasting plasma glucose
timeFrame: baseline and week 52
measure: Change in Body Weight
timeFrame: baseline and week 52
measure: Change in Blood pressure
timeFrame: baseline and week 52
measure: Change in Uric Acid
timeFrame: baseline and week 52
measure: Change in Total cholesterol
timeFrame: baseline and week 52
measure: Change in HDL-C
timeFrame: baseline and week 52
measure: Change in LDL-C
timeFrame: baseline and week 52
measure: Change in non HDL-C
timeFrame: baseline and week 52
measure: Change in Free Fatty Acid
timeFrame: baseline and week 52
Other outcomes:
Locations:
city: Atsuta-ku
country: Japan
state: Aichi
city: Minato-ku
country: Japan
state: Aichi
city: Kisarazu
country: Japan
state: Chiba
city: Annaka
country: Japan
state: Gunma
city: Naka
country: Japan
state: Ibaraki
city: Sagamihara
country: Japan
state: Kanagawa
city: Kasaoka
country: Japan
state: Okayama
city: Shimono
country: Japan
state: Tochigi
city: Adachi-ku
country: Japan
state: Tokyo
city: Chuo-ku
country: Japan
state: Tokyo
city: Mitaka
country: Japan
state: Tokyo
Study officials:
References:
citation: Terauchi Y, Fujiwara H, Kurihara Y, Suganami H, Tamura M, Senda M, Gunji R, Kaku K. Long-term safety and efficacy of the sodium-glucose cotransporter 2 inhibitor, tofogliflozin, added on glucagon-like peptide-1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52-week open-label, multicenter, post-marketing clinical study. J Diabetes Investig. 2019 Nov;10(6):1518-1526. doi: 10.1111/jdi.13066. Epub 2019 May 28.