Clinical trial NCT02096705: Phase III Insulin Add-On Asia Regional Program - ST
Official title: A 24-week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate Efficacy and Safety of Dapagliflozin Added to Therapy of Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2014-03-26
Enrollment: 477
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Subjects must have type 2 diabetes with inadequate glycemic control, defined as HbA1c ≥ 7.5% and ≤ 11.0% obtained at screening visit
* Subjects must be taking a stable mean dose of ≥ 20 IU injectable insulin daily for at least 8 weeks prior to enrollment

Inclusion criteria for randomization:

HbA1c ≥ 7.5 and ≤ 10.5% at Day -14

Exclusion Criteria:

* Treatment with more than two oral antidiabetic (OAD) agents within 6 weeks of Enrollment
* History of diabetic ketoacidosis of hyperosmolar nonketotic coma
* Clinically diagnosed Type 1 diabetes mellitus
* Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV
* Severe uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 110 mmHg
* History of unstable or rapidly progressing renal disease
* History of severe hepatobiliary disease
* Mallingancy within 5 years of the screening/enrollment visit

Primary outcomes:
measure: Adjusted Mean Change in HbA1c From Baseline to Week 24
timeFrame: Baseline (Day 1) and 24 weeks
Secondary outcomes:
measure: Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24
timeFrame: Baseline (Day 1) and 24 weeks
measure: Adjusted Mean Change in Body Weight From Baseline to Week 24
timeFrame: Baseline (Day 1) and 24 weeks
measure: Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24
timeFrame: Baseline (Day 1) and 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Haerbin
country: China
facility: Local Institution
state: Heilongjiang
city: Changsha
country: China
facility: Local Institution
state: Hunan
city: Changsha
country: China
facility: Local Institution
state: Hunan
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Suzhou
country: China
facility: Local Institution
state: Jiangsu
city: Wuxi
country: China
facility: Local Institution
state: Jiangsu
city: Changchun
country: China
facility: Local Institution
state: Jilin
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Xi An
country: China
facility: Local Institution
state: Shanxi
city: Xi'an
country: China
facility: Local Institution
state: Shanxi
city: Chengdu
country: China
facility: Local Institution
state: Sichuan
city: Chongqing
country: China
facility: Local Institution
state: Sichuan
city: Beijing
country: China
facility: Local Institution
city: Tianjin
country: China
facility: Local Institution
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Daejeon
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
Study officials:
References: