52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
891 participants were enrolled in the study; 33 participants did not enter the treatment period; 858 participants were randomized and treated.

Reporting Groups

	Description
Saxagliptin + Metformin	Saxagliptin 5 mg tablets added on to open-label metformin
Glipizide + Metformin	Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin

Participant Flow:   Overall Study

	Saxagliptin + Metformin	Glipizide + Metformin
STARTED	428 [1]	430 [1]
COMPLETED	165 [2]	147 [2]
NOT COMPLETED	263	283
Adverse Event	11	13
Withdrawal by Subject	27	31
Lost to Follow-up	1	3
Death	4	2
Incorrect enrollment	8	4
Study specific discontinuation criteria	203	218
Severe non-compliance to protocol	5	7
Safety reasons	2	1
Elevated triglyceride	1	0
Patient moved	1	3
Impossible to determine HbA1c	0	1

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Saxagliptin + Metformin	Saxagliptin 5 mg tablets added on to open-label metformin
Glipizide + Metformin	Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
Total	Total of all reporting groups

Baseline Measures

	Saxagliptin + Metformin	Glipizide + Metformin	Total
Overall Participants Analyzed  [Units: Participants]	428	430	858
Age  [Units: Years] Mean (Standard Deviation)	57.50  (10.26)	57.59  (10.37)	57.55  (10.31)
Gender  [Units: Participants]
Female	216	198	414
Male	212	232	444

1.  Primary:

Hemoglobin A1c (HbA1c) Change From Baseline to Week 52   [ Time Frame: Baseline to 52 Weeks ]

2.  Secondary:

Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks   [ Time Frame: From Baseline to Week 52 ]

3.  Secondary:

Body Weight Change From Baseline to Week 52   [ Time Frame: Baseline, Week 52 (Last Observation Carried Forward) ]

4.  Secondary:

Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c   [ Time Frame: Week 24 to Week 52 ]

5.  Other Pre-specified:

Hemoglobin A1c (HbA1c) Change From Baseline to Week 104   [ Time Frame: Baseline, Week 104 ]

6.  Other Pre-specified:

Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks   [ Time Frame: Baseline, Week 104 ]

7.  Other Pre-specified:

Body Weight Change From Baseline to Week 104   [ Time Frame: Baseline, Week 104 ]

8.  Other Pre-specified:

Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c   [ Time Frame: Week 24 to Week 104 ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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