A Study of ASP1941 in Participants With Type 2 Diabetes Mellitus

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus, Type 2, ASP1941

Brief summary

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus

Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH.

2019-10-129 citations

10.1007/s13300-019-00699-8

Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes stratified by body mass index: A subgroup analysis of five randomized clinical trials.

Kashiwagi A, Yoshida S, Nakamura I, Kazuta K, Ueyama E, Takahashi H, Satomi H, Kosakai Y, Kawamuki K.

2016-03-0127 citations

10.1111/jdi.12471

Randomized, placebo‐controlled, double‐blind glycemic control trial of novel sodium‐dependent glucose cotransporter 2 inhibitor ipragliflozin in Japanese patients with type 2 diabetes mellitus

Atsunori Kashiwagi, Kenichi Kazuta, Satoshi Yoshida, Itsuro Nagase

Journal of Diabetes Investigation2013-11-2898 citations

10.1111/jdi.12156

Interventions

DRUGipragliflozin

Oral

DRUGPlacebo

Oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

* Established diagnosis of type 2 diabetes mellitus * Fasting serum C-peptide level \> 0.6 ng/mL * HbA1c between 7.0 and 10.0% * Body Mass Index between 20 and 45 kg/m2

Exclusion criteria

* Serum creatinine \> upper limit of normal * Proteinuria (albumin/creatinine ratio \> 300 mg/g) * Dysuria and/or urinary tract infection * Significant renal, hepatic or cardiovascular diseases * Ketosis * Hypertension * Severe gastrointestinal diseases

Design outcomes

Primary

Measure	Time frame
HbA1c level	12 weeks

Secondary

Measure	Time frame
Blood glucose level	12 Weeks
Safety	12 Weeks

Countries

Japan

Outcome results

None listed