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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.

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Official Title

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients with inadequate glycaemic control with diet and exercise.

Evaluate Efficacy and Safety of Saxagliptin  in Adult Patients with Type 2 Diabetes inadequate glycemic control

5mg, oral tablet, once daily for 24 weeks

Research Site

A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled, Phase III study to Evaluate the Efficacy and Safety of Saxagliptin in Adult Patients with Type 2 Diabetes who have Inadequate Glycaemic Control with Diet and Exercise.

Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.

Age Continuous

Gender, Male/Female

Baseline

Week 24

Adjusted Mean Change from Baseline

Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.

Absolute change from baseline to week 24  in glycosylated haemoglobin A1c (HbA1c)

week 24

Adjusted mean change from Baseline

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (Last Observation Carried Forward (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.

Absolute change (mmol/L) from baseline to week 24 in fasting plasma glucose (FPG)

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.

Absolute change (mg/dL) from baseline to week 24 in fasting plasma glucose (FPG)

Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication

MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized subjects, who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had baseline and post-baseline data. Measurements observed on and after rescue medication were excluded.

Absolute change (mmol*min/L) from baseline to week 24 in area under the curve (AUC) from 0 to 180 minutes for postprandial glucose (PPG) during mixed meal (instant noodles) tolerance tests (MMTT) in all MMTT participants

Absolute change (mg*min/dL) from baseline to week 24 in area under the curve (AUC) from 0 to 180 minutes for postprandial glucose (PPG) during mixed meal (instant noodles) tolerance tests (MMTT) in all MMTT participants

Proportion of participants (expressed in percentage of total participants) achieving HbA1c < 7.0% for saxagliptin versus placebo at week 24. HbA1c Data were excluded on and after rescue medication

Arms	Assigned Interventions
Experimental: Saxagliptin 5mg	Drug: Saxagliptin 5mg, oral tablet, once daily for 24 weeks Other Name: Onglyza
Placebo Comparator: Placebo	Drug: Placebo oral tablet, once daily for 24 weeks

Evaluate Efficacy and Safety of Saxagliptin in Adult Patients with Type 2 Diabetes inadequate glycemic control

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Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=282&filename=CSR-D1680C00005.pdf

CSR-D1680C00005.pdf

Trial Results Summaries

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