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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

This study is carried out to assess whether dapagliflozin improves glycemic control, decreases fasting plasma glucose levels,  body weight and blood pressure when added to patient's existing medications and  how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes and cardiovascular disease

Efficacy and Safety in Patients with type 2 Diabetes Mellitus and Cardiovascular Disease

10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period

matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period

Research Site

A 24-week, multicentre, randomised, double-blind,age-stratified, placebo controlled phase III study with an 80-week extension period to evaluate the efficacy and safety of dapagliflozin 10 mg once daily in patients with T2DM and cardiovascular disease, who exhibit inadequate glycaemic control on usual care

To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease, measured as the mean change in HbA1c from baseline to week 24, in the overall population and in the two predefined age subgroups (<65 years, ≥65 years). Primary endpoints are tested at alpha=0.025. Analysis of continuous outcome based on ANCOVA model with treatment group and stratum as effect and baseline value as covariate. Outcome measure type Least Squares Mean represents adjusted mean change from baseline. Difference from placebo: -0.40 (-0.50, -0.30), p<0.0001.

To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure in the overall population and in the two predefined age subgroups. Primary endpoints are tested at alpha=0.025. Analysis based on Cochran-Mantel-Haenszel method with age-by-insulin use-by-time from most recent qualifying CV event as stratum. Outcome measure type Number represents rate of responders. Difference from placebo: 7.0 (4.3, 9.8), p<0.0001.

Age Continuous

Gender, Male/Female

Race, Customized

HbA1c

Study Specific Characteristic

Body weight

Systolic Blood Pressure

Number of participants with BMI >= 27 kg/m2 at baseline

Full Analysis Set defined as all randomized participants (as randomized) who received at least one dose of double-blind study medication, who have a non-missing baseline value and at least one post-baseline efficacy value for at least one efficacy variable during double-blind treatment period. 

For participants who did not complete 8 and/or 24 weeks, respectively, LOCF was used. For HbA1c: excluding data after glycemic rescue, Weight: including data after rescue, SBP: excluding data after anti-hypertensive rescue.

To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease, measured as the mean change in HbA1c from baseline to week 24.

H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0

Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values

Adjusted mean change in HbA1c levels

To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.

H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0

Full Analysis Set, subjects with non-missing baseline and Week 24 (LOCF) values

Proportion of responders meeting all criteria of a 3-item endpoint of clinical benefit

To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.

Adjusted mean percent change in body weight

To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum.

Full Analysis Set, subjects with baseline BMI ≥27 kg/m2 and Week 24 (LOCF) values

Proportion of participants with a reduction from baseline of 5% or more in body weight in participants with baseline BMI ≥27 kg/m²

To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.

Full Analysis Set, subjects with non-missing baseline and Week 8 (LOCF) values

Adjusted mean change in systolic blood pressure at Week 8 (LOCF)

To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo.

Full Analysis set, subjects with non-missing baseline and Week 24 (LOCF) values

Adjusted mean change in seated systolic blood pressure at Week 24 (LOCF)

To compare the mean change in seated systolic blood pressure (SBP) in participants with baseline seated SBP ≥130 mmHg achieved with dapagliflozin versus placebo from baseline to week 8.

Full Analysis set, participants with baseline seated SBP ≥130 mmHg and Week 8 (LOCF) value

Adjusted mean change in seated systolic blood pressure (SBP) at Week 8 (LOCF) in participants with baseline SBP>=130 mmHg

Overall Study

During a placebo lead-in period, participants were counselled on dietary and life-style modifications. Anti-diabetic therapy should be kept constant 4 weeks prior to enrolment. Participants eligible for the study were stratified according to age (<65 years or ≥65 years), insulin use and time from most recent qualifying CV event (>1 or ≤1 year).

Eva Johnsson

To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo, in the overall population and in the two predefined age subgroups (<65 years, ≥65 years). If at least one p-value for primary analysis is significant, key secondary endpoints are tested following a hierarchical closed testing procedure at alpha=0.05/0.025. Analysis of continuous outcome based on ANCOVA model with treatment group and stratum as effect and baseline value as covariate. Outcome measure type Least Squares Mean represents adjusted mean change from baseline. Difference from placebo: -1.93 (-2.31, -1.54), p<0.0001.

To compare the proportion of participants with baseline BMI ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24, in the overall population and in the two predefined age subgroups (<65 years, ≥65 years). If at least one p-value for primary analysis is significant, key secondary endpoints are tested following a hierarchical closed testing procedure at alpha=0.05/0.025. Logistic regression analysis of responses based on methodology of Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu, with adjustment for baseline weight and stratum. Outcome measure type Least Squares Mean represents adjusted percent. Difference from placebo: 13.6 (9.4, 17.8), p<0.0001.

To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo, in the overall population and in the two predefined age subgroups (<65 years, ≥65 years). If at least one p-value for primary analysis is significant, key secondary endpoints are tested following a hierarchical closed testing procedure at alpha=0.05/0.025. Analysis of continuous outcome based on ANCOVA model with treatment group and stratum as effect and baseline value as covariate. Outcome measure type Least Squares Mean represents adjusted mean change from baseline. Difference from placebo: -2.71 (-4.28, -1.15), p=0.0007.

To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo, in the overall population and in the two predefined age subgroups (<65 years, ≥65 years). If at least one p-value for primary analysis is significant, key secondary endpoints are tested following a hierarchical closed testing procedure at alpha=0.05/0.025. Analysis of continuous outcome based on ANCOVA model with treatment group and stratum as effect and baseline value as covariate. Outcome measure type Least Squares Mean represents adjusted mean change from baseline. Difference from placebo: -3.02 (-4.59, -1.46), p=0.0002.

To compare the mean change in seated systolic blood pressure (SBP) in participants with baseline seated SBP ≥130 mmHg achieved with dapagliflozin versus placebo from baseline to week 8, in the overall population and in the two predefined age subgroups (<65 years, ≥65 years). If at least one p-value for primary analysis is significant, key secondary endpoints are tested following a hierarchical closed testing procedure at alpha=0.05/0.025. Analysis of continuous outcome based on ANCOVA model with treatment group and stratum as effect and baseline value as covariate. Outcome measure type Least Squares Mean represents adjusted mean change from baseline. Difference from placebo: -3.44 (-5.35, -1.53), p=0.0004.

Arms	Assigned Interventions
Experimental: 1 dapagliflozin 10 mg tablet	Drug: Dapagliflozin 10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period
Placebo Comparator: 2 matching placebo tablet	Drug: Placebo matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period

Efficacy and Safety in Patients with type 2 Diabetes Mellitus and Cardiovascular Disease

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

CSR-D1690C00019.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator