Title

Saxagliptin Triple Oral Therapy
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
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Intervention/Treatment

    saxagliptin ...
  • Study Participants

    257
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.
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 Started
Jun 30
2010
Primary Completion
Jun 30
2011
Study Completion
Jun 30
2011
Results Posted
Aug 03
2012
Estimate
Last Update
Aug 10
2012
Estimate

Drug Saxagliptin

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

  • Other names: Onglyza

Drug Placebo

tablet once daily for 24 weeks to be taken orally

Saxagliptin 5 mg once daily Experimental

Placebo once daily Placebo Comparator

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

Summary

SAXAGLIPTIN

PLACEBO

All Events

Event Type Organ System Event Term SAXAGLIPTIN PLACEBO

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

Arm 1 - SAXAGLIPTIN

-0.74
percent (Mean)
95% Confidence Interval: -0.89 to -0.6

Arm 2 - PLACEBO

-0.08
percent (Mean)
95% Confidence Interval: -0.23 to 0.07

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

Arm 1 - SAXAGLIPTIN

-0.65
mmol/L (Mean)
95% Confidence Interval: -1.3 to 0.0

Arm 2 - PLACEBO

0.28
mmol/L (Mean)
95% Confidence Interval: -0.36 to 0.92

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

Arm 1 - SAXAGLIPTIN

-5.28
mg/dL (Mean)
95% Confidence Interval: -12.67 to 2.11

Arm 2 - PLACEBO

2.62
mg/dL (Mean)
95% Confidence Interval: -4.47 to 9.71

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

Arm 1 - SAXAGLIPTIN

-11.66
mg/dL (Mean)
95% Confidence Interval: -23.38 to 0.07

Arm 2 - PLACEBO

5.08
mg/dL (Mean)
95% Confidence Interval: -6.45 to 16.6

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

Arm 1 - SAXAGLIPTIN

-0.29
mmol/L (Mean)
95% Confidence Interval: -0.7 to 0.12

Arm 2 - PLACEBO

0.15
mmol/L (Mean)
95% Confidence Interval: -0.25 to 0.54

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

Arm 1 - SAXAGLIPTIN

39.0
Participants

Arm 2 - PLACEBO

12.0
Participants

Total

257
Participants

2-hour Postprandial glucose

14.84
mmol/L (Mean)
Standard Deviation: 4.064

2-hour Postprandial Glucose

267.39
mg/dL (Mean)
Standard Deviation: 73.220

Age Continuous

57.0
years (Mean)
Standard Deviation: 10.54

BMI

29.2
kg/m2 (Mean)
Standard Deviation: 5.09

Fasting Plasma Glucose

158.84
mg/dL (Mean)
Standard Deviation: 43.125

Fasting Plasma Glucose

8.82
mmol/L (Mean)
Standard Deviation: 2.393

HbA1c

8.28
% (Mean)
Standard Deviation: 0.848

Race/Ethnicity, Customized

Region of Enrollment

Sex: Female, Male

Overall Study

SAXAGLIPTIN

PLACEBO

Drop/Withdrawal Reasons

SAXAGLIPTIN

PLACEBO