Clinical trial NCT01257412: Evaluation of Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone
Official title: A 24-week National Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Trial in India to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Phase III
Type 2 Diabetes Mellitus
inadequate glycaemic control
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-12-09
Enrollment: 375
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study intends to compare the efficacy and safety of dapagliflozin versus placebo in treatment-naïve subjects with type 2 diabetes who have inadequate glycaemic control with diet and exercise alone.


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent before participating in the study
* Diagnosed with type 2 diabetes (high blood sugar); HbA1c ≥ 7.2% and ≤10.0%
* Subjects should be drug naïve
* Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study \& who have a negative serum or urine pregnancy test

Exclusion Criteria:

* Subjects received Insulin therapy within one year of enrollment
* Subjects who have severe uncontrolled hypertension
* Subjects who have history of unstable or rapidly progressing renal disease
* Subjects who have severe liver disease
* Subjects who receiving treatment for Human immunodeficiency virus (HIV)

Primary outcomes:
measure: change in glycosylated haemoglobin A1c (HbA1c).
timeFrame: From baseline to week 24
Secondary outcomes:
measure: mean change in fasting plasma glucose (FPG)
timeFrame: From baseline to week 24
measure: mean change in 2- hour postprandial glucose by Mixed Meal Test
timeFrame: From baseline to week 24
measure: mean change from baseline in fasting plasma glucose (FPG)
timeFrame: From baseline to week 1
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Research Site
state: Andhra Pradesh
city: Vijaywada
country: India
facility: Research Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Research Site
state: Gujarat
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Mysore
country: India
facility: Research Site
state: Karnataka
city: Trivandrum
country: India
facility: Research Site
state: Kerala
city: Indore
country: India
facility: Research Site
state: Madhya Pradesh
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Nagpur
country: India
facility: Research Site
state: Maharashtra
city: Pune
country: India
facility: Research Site
state: Maharashtra
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Chennai
country: India
facility: Research Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Research Site
state: Tamil Nadu
city: Madurai
country: India
facility: Research Site
state: Tamil Nadu
city: Ghaziabad
country: India
facility: Research Site
state: Uttar Pradesh
Study officials:
affiliation: Dr. A. Ramachandran's Diabetes Hospital
name: Prof. A. Ramachandran, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: