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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 Indian patients with inadequate glycaemic control with diet and exercise.

Evaluate Saxagliptin  in Adult Indian Patients with Type 2 Diabetes inadequate glycemic control

Research Site

A 24-Week National, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled, Phase IIIb study in India 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 glycosylated haemoglobin A1c (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 Change from Baseline to Week 24

Adjusted* mean change from baseline in glycosylated haemoglobin A1c (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.    

Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of 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)

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 from baseline to Week 24 in fasting plasma glucose (FPG)

Proportion of participants (expressed in percentage of total participants)achieving HbA1c < 7.0% for saxagliptin versus placebo at Week 24 (LOCF, Full Analysis set). HbA1c data were excluded on and after rescue
medication

Arms	Assigned Interventions
Experimental: 1 Saxagliptin	Drug: Saxagliptin Oral tablet, once daily for 24 weeks Other Name: Onglyza
Placebo Comparator: 2	Drug: Placebo Oral tablet, once daily for 24 weeks

Evaluate Saxagliptin in Adult Indian Patients with Type 2 Diabetes inadequate glycemic control

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

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Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

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Inclusion Criteria

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Research Site

Research Site

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Research Site

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Research Site

Documents available

CSR-D1680C00008.pdf

D1680C00008 Clinical Study Protocol

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator