Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 October 2017 |
Main ID: |
NCT01128153 |
Date of registration:
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20/05/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Saxagliptin Triple Oral Therapy
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Scientific title:
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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 |
Date of first enrolment:
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June 2010 |
Target sample size:
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257 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01128153 |
Study type:
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Interventional |
Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Canada
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India
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Korea, Republic of
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Thailand
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United Kingdom
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Contacts
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Name:
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Simon Fisher, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Name:
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Vinod Mattoo, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Name:
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Jayanti Visvanthan, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Name:
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Robert Moses, MBBS |
Address:
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Telephone:
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Email:
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Affiliation:
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Sydney Diabetes Centre |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes
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Intervention(s)
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Drug: Placebo
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Drug: Saxagliptin
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Primary Outcome(s)
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Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)
[Time Frame: From Baseline to Week 24 weeks]
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Secondary Outcome(s)
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Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)
[Time Frame: From Baseline to Week 24]
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Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
[Time Frame: From Baseline to Week 24]
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Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
[Time Frame: From Baseline to Week 24]
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Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
[Time Frame: From Baseline to Week 24]
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Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
[Time Frame: From Baseline to Week 24]
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Secondary ID(s)
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CV181-117
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D1680L00006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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