Skip to main content
OpenTrials
Completed

NCT Number: NCT01128153

Saxagliptin Triple Oral Therapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Broadmeadow, New South Wales, Australia

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saxagliptin

Drug

5 mg tablet once daily for 24 weeks to be taken orally

Other names: Onglyza

Placebo

Drug

tablet once daily for 24 weeks to be taken orally

Primary outcomes

  1. Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)

    Time frame: From Baseline to Week 24 weeks

    Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model

Secondary outcomes

  1. 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

    Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model

  2. 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

    Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model

  3. 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

    Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance

  4. 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

    Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model

  5. 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

    Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 21, 2010
Registry last updated
Aug 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.