Saxagliptin Triple Oral Therapy

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01128153
• Other study ID #: D1680L00006
• Secondary ID: CV181-117
• Status: Completed
• Phase: Phase 3
• First received: May 20, 2010
• Last updated: August 7, 2012
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods AdministrationAustralia: Human Research Ethics CommitteeUnited Kingdom: National Health ServiceUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyIndia: Drugs Controller General of IndiaIndia: Institutional Review BoardKorea: Food and Drug AdministrationThailand: Ethical CommitteeThailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Saxagliptin
5 mg tablet once daily for 24 weeks to be taken orally
• Placebo
tablet once daily for 24 weeks to be taken orally

Locations

Country	Name	City	State
Australia	Research Site	Broadmeadow	New South Wales
Australia	Research Site	Camperdown
Australia	Research Site	Daw Park	South Australia
Australia	Research Site	Elizabeth Vale	South Australia
Australia	Research Site	Herston
Australia	Research Site	Melbourne	Victoria
Australia	Research Site	Wollongong	New South Wales
Canada	Research Site	Kensington	Prince Edward Island
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Sydney Mines	Nova Scotia
Canada	Research Site	Thornhill	Ontario
India	Research Site	Bangalore	Karnataka
India	Research Site	Coimbatore	Tamil Nadu
India	Research Site	Indore	Madhya Pradesh
India	Research Site	Karnal	Haryana
India	Research Site	Pune	Maharashtra
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Goyang	Kyounggi-do
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Wonju	Kangwon-do
Thailand	Research Site	Bangkok
United Kingdom	Research Site	Ashford
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Blackpool
United Kingdom	Research Site	Chesterfield
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	ELY	Cambridgeshire
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Peterborough
United Kingdom	Research Site	Reading	Berks
United Kingdom	Research Site	Wellingborough
United Kingdom	Research Site	Westbury	Wiltshire
United Kingdom	Research Site	Whitstable	Kent

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

Australia,  Canada,  India,  Korea, Republic of,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)	Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model	From Baseline to Week 24 weeks	No
Secondary	Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]	Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model	From Baseline to Week 24	No
Secondary	Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]	Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model	From Baseline to Week 24	No
Secondary	Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]	Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance	From Baseline to Week 24	No
Secondary	Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]	Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model	From Baseline to Week 24	No
Secondary	Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)	Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24	From Baseline to Week 24	No