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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 test the efficacy of once daily saxagliptin in renally impaired patients.

Treatment Effect of Saxagliptin compared with placebo in Patients with Type 2 Diabetes and Renal Impairment

Research Site

A Short-term 12-Week, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Saxagliptin compared with Placebo in Adult Patients with Type 2 Diabetes and Renal Impairment (Moderate, Severe, and End-Stage) with an additional 40-week, Randomized, Double-blind, Placebo-controlled Long-term Observational Period.

Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set).  HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.

Age Continuous

Gender, Male/Female

Baseline Renal Impairment Category

Study Specific Characteristic

Baseline Diabetes Therapy

Baseline

Week 12

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 Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.

Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) level to Week 12 Last observation carried forward (LOCF)

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup.  FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.

Additional details about the analysis, such as null hypothesis and power calculation:
Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category.

Absolute change from baseline in fasting plasma glucose (FPG) to Week 12 (LOCF)- Moderate  Renal Impairment Subgroup

Adjusted mean change

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup.  FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.

Absolute change from baseline in fasting plasma glucose (FPG) to Week 12 (LOCF) - Severe  Renal Impairment Subgroup

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup.  FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.

Absolute change from baseline in fasting plasma glucose (FPG) to Week 12 (LOCF) - End-Stage  Renal Impairment Subgroup

Absolute mean change

Absolute change from baseline in fasting plasma glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup

Absolute change from baseline in fasting plasma glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup

Week 52

Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set).  HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.

Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.  Data were excluded after changes in oral blood glucose lowering drug or insulin.

Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) level to Week 52

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup.  FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.

Absolute change from baseline in fasting plasma glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup.  FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.

Absolute change from baseline in fasting plasma glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup.  FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.

Absolute change from baseline in fasting plasma glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup.  FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value

Overall Study

A total of 572 participants were enrolled in the study; 561 entered the Lead-in period and 170 patients were randomized and treated.

Arms	Assigned Interventions
Experimental: Saxa Saxagliptin	Drug: Saxagliptin 2.5 mg once daily oral dose Other Name: Onglyza
No Intervention: Placebo Placebo to match	Drug: Placebo Placebo

Treatment Effect of Saxagliptin compared with placebo in Patients with Type 2 Diabetes and Renal Impairment

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=284&filename=CSR-D1680C00007.pdf

CSR-D1680C00007.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator