Clinical trial NCT01128153: Saxagliptin Triple Oral Therapy
Official title: A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin and Sulfonylurea in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Combination of Metformin and Sulfonylurea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Inadequate Glycaemic Control
Saxagliptin
Metformin
Sulfonylurea
Triple Oral Therapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-05-21
Enrollment: 257
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 of this study is to determine whether the addition of saxagliptin to a patient's combination treatment of metformin and sulfonylurea for a 24 week period will provide better control of the patient's type 2 diabetes and will be well tolerated.

Detailed description: A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control with Combination of Metformin and Sulfonylurea

Eligibility criteria: Inclusion Criteria:

* Written Informed Consent
* Males or females with type 2 diabetes with inadequate glycaemic control (HbA1c \> or = 7% and \< or = 10%) despite being on combination of metformin and sulfonylurea for at least 8 weeks prior to Visit 1
* BMI \< or = 40 kg/m2

Exclusion Criteria:

* Symptoms of poorly controlled diabetes including but not limited to marked polyuria and marked polydipsia with \> 10% weight loss in 3 months prior to entry, or other signs and symptoms
* History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
* Current or prior use within 3 months of Visit 1 of insulin, DDP4 inhibitor, GLP-1 analogues, and/or other oral anti-diabetic agents (other than metformin or sulfonylurea)
* Treatment with CYP3A4 inducers and/or potent CYP3A4/5 inhibitor
* Estimated CrCl \< 60 ml/min at Visit 2
* CHF (NYHA class III or IV) and/or LVEF \<40%
* Active liver disease and/or significant abnormal liver function defined as AST and/or ALT \> 3 x ULN and/or bilirubin \> 2.0 mg/dL at Visit 2.
* Creatine kinase \> or = 10 x ULN at Visit 2

Primary outcomes:
measure: Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)
timeFrame: From Baseline to Week 24 weeks
Secondary outcomes:
measure: Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
timeFrame: From Baseline to Week 24
measure: Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
timeFrame: From Baseline to Week 24
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
timeFrame: From Baseline to Week 24
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
timeFrame: From Baseline to Week 24
measure: Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)
timeFrame: From Baseline to Week 24
Other outcomes:
Locations:
city: Broadmeadow
country: Australia
facility: Research Site
state: New South Wales
city: Wollongong
country: Australia
facility: Research Site
state: New South Wales
city: Daw Park
country: Australia
facility: Research Site
state: South Australia
city: Elizabeth Vale
country: Australia
facility: Research Site
state: South Australia
city: Melbourne
country: Australia
facility: Research Site
state: Victoria
city: Camperdown
country: Australia
facility: Research Site
city: Herston
country: Australia
facility: Research Site
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Sydney Mines
country: Canada
facility: Research Site
state: Nova Scotia
city: Thornhill
country: Canada
facility: Research Site
state: Ontario
city: Kensington
country: Canada
facility: Research Site
state: Prince Edward Island
city: Karnal
country: India
facility: Research Site
state: Haryana
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Indore
country: India
facility: Research Site
state: Madhya Pradesh
city: Pune
country: India
facility: Research Site
state: Maharashtra
city: Coimbatore
country: India
facility: Research Site
state: Tamil Nadu
city: Wonju
country: Korea, Republic of
facility: Research Site
state: Kangwon-do
city: Goyang
country: Korea, Republic of
facility: Research Site
state: Kyounggi-do
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
state: Berks
city: ELY
country: United Kingdom
facility: Research Site
state: Cambridgeshire
city: Whitstable
country: United Kingdom
facility: Research Site
state: Kent
city: Westbury
country: United Kingdom
facility: Research Site
state: Wiltshire
city: Ashford
country: United Kingdom
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Chesterfield
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Peterborough
country: United Kingdom
facility: Research Site
city: Wellingborough
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Jayanti Visvanthan, MD
role: STUDY_CHAIR
affiliation: AstraZeneca
name: Simon Fisher, MD
role: STUDY_CHAIR
affiliation: Bristol-Myers Squibb
name: Vinod Mattoo, MD
role: STUDY_CHAIR
affiliation: Sydney Diabetes Centre
name: Robert Moses, MBBS
role: PRINCIPAL_INVESTIGATOR
References: