Clinical trial NCT00972244: Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Japanese
phase 2
efficacy
safety
dapagliflozin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2009-09-04
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of dapagliflozin to placebo when given in oral doses.


Eligibility criteria: Inclusion Criteria:

* Japanese Subjects with type 2 diabetes mellitus.
* Strictly/relatively treatment naïve Subjects with HbA1c ≥ 7.0% and ≤ 10%, or Subjects treated with single or two (less than half of the approved maximal dose for each) oral anti-hyperglycaemic agent with HbA1c ≤ 8%.
* Provision of informed consent.

Exclusion Criteria:

* Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease.
* The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.

Primary outcomes:
measure: Adjusted Mean Change in HbA1c Levels
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Adjusted Mean Change in Fasting Plasma Glucose
timeFrame: Baseline to Week 12
measure: Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
timeFrame: At Week 12
Other outcomes:
Locations:
city: Anjyo
country: Japan
facility: Research Site
city: Bunkyo-ku
country: Japan
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Daito
country: Japan
facility: Research Site
city: Kamagaya
country: Japan
facility: Research Site
city: Kashiwara
country: Japan
facility: Research Site
city: Matsuyama
country: Japan
facility: Research Site
city: Nagoya
country: Japan
facility: Research Site
city: Nakano-ku
country: Japan
facility: Research Site
city: Naka
country: Japan
facility: Research Site
city: Nerima-ku
country: Japan
facility: Research Site
city: Okinawa
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Sapporo
country: Japan
facility: Research Site
city: Shibuya-ku
country: Japan
facility: Research Site
city: Shinjyuku-ku
country: Japan
facility: Research Site
city: Suita
country: Japan
facility: Research Site
city: Uji
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Yamato
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Parikh Shamik
role: STUDY_DIRECTOR
References:
citation: Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.