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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01128153




Registration number
NCT01128153
Ethics application status
Date submitted
20/05/2010
Date registered
21/05/2010
Date last updated
10/08/2012

Titles & IDs
Public title
Saxagliptin Triple Oral Therapy
Scientific 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
Secondary ID [1] 0 0
CV181-117
Secondary ID [2] 0 0
D1680L00006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Saxagliptin
Treatment: Drugs - Placebo

Experimental: Saxagliptin 5 mg once daily -

Placebo Comparator: Placebo once daily -


Treatment: Drugs: Saxagliptin
5 mg tablet once daily for 24 weeks to be taken orally

Treatment: Drugs: Placebo
tablet once daily for 24 weeks to be taken orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)
Timepoint [1] 0 0
From Baseline to Week 24 weeks
Secondary outcome [1] 0 0
Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
Timepoint [1] 0 0
From Baseline to Week 24
Secondary outcome [2] 0 0
Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
Timepoint [2] 0 0
From Baseline to Week 24
Secondary outcome [3] 0 0
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
Timepoint [3] 0 0
From Baseline to Week 24
Secondary outcome [4] 0 0
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
Timepoint [4] 0 0
From Baseline to Week 24
Secondary outcome [5] 0 0
Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)
Timepoint [5] 0 0
From Baseline to Week 24

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
257
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Broadmeadow
Recruitment hospital [2] 0 0
Research Site - Wollongong
Recruitment hospital [3] 0 0
Research Site - Daw Park
Recruitment hospital [4] 0 0
Research Site - Elizabeth Vale
Recruitment hospital [5] 0 0
Research Site - Melbourne
Recruitment hospital [6] 0 0
Research Site - Camperdown
Recruitment hospital [7] 0 0
Research Site - Herston
Recruitment postcode(s) [1] 0 0
- Broadmeadow
Recruitment postcode(s) [2] 0 0
- Wollongong
Recruitment postcode(s) [3] 0 0
- Daw Park
Recruitment postcode(s) [4] 0 0
- Elizabeth Vale
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Camperdown
Recruitment postcode(s) [7] 0 0
- Herston
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Newfoundland and Labrador
Country [2] 0 0
Canada
State/province [2] 0 0
Nova Scotia
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Prince Edward Island
Country [5] 0 0
India
State/province [5] 0 0
Haryana
Country [6] 0 0
India
State/province [6] 0 0
Karnataka
Country [7] 0 0
India
State/province [7] 0 0
Madhya Pradesh
Country [8] 0 0
India
State/province [8] 0 0
Maharashtra
Country [9] 0 0
India
State/province [9] 0 0
Tamil Nadu
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Kangwon-do
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Kyounggi-do
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Daegu
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Seoul
Country [14] 0 0
Thailand
State/province [14] 0 0
Bangkok
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Berks
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Cambridgeshire
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Kent
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Wiltshire
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Ashford
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Belfast
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Blackpool
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Chesterfield
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Coventry
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Glasgow
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Peterborough
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Wellingborough

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01128153
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jayanti Visvanthan, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01128153