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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 aims to investigate how dapagliflozin can control blood sugar in patients with type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with metformin). The effect of dapagliflozin on weight and blood pressure will also be studied.

Dapagliflozin DPPIV inhibitor add-on study

D1690C00010_Clinical_Study_Report_Synopsis

D1690C00010_Revised_CSP1_and_Amdt_1_Priv_Redacted

Research Site

A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study with 24 week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in patients with Type 2 Diabetes who have Inadequate Glycemic Control on a DPP-4 inhibitor Sitagliptin+/-Metformin

To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin. Primary endpoint tested at alpha=0.05. 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: -0.48 (-0.62,  -0.34), p<0.0001.

Age Continuous

Gender, Male/Female

HbA1c

Study Specific Characteristic

Body weight

Seated SBP in subjects with baseline seated SBP ≥130 mmHg

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. All endpoints were evaluated by excluding data after rescue with the exception of systolic blood pressure which was evaluated regardless of rescue medication. 

To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.

H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group

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

Adjusted mean change in HbA1c levels

To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24.

Adjusted mean change in body weight

To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24.

Full analysis set, participants with baseline HbA1c >=8% and Week 24 (LOCF) value

Adjusted mean change in HbA1c in participants with baseline HbA1c ≥8%

To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24.

Adjusted mean change in Fasting Plasma Glucose (FPG)

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

Full analysis set, participants with baseline SBP>=130mmHg and Week 8 (LOCF) value

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

To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24.

Adjusted mean change in 2-hour post liquid meal glucose rise

To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.

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

Proportion of participants achieving a therapeutic glycemic response defined as a reduction in HbA1c of ≥0.7% compared to baseline

Overall Study

During a placebo lead-in period, participants were counselled on dietary and life-style modifications. Participants eligible for the study were stratified according to use of metformin.

Eva Johnsson

To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24. If p-value for primary endpoint significant, key secondary endpoints are tested following a hierarchical closed testing procedure. 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: -1.89 (-2.37, -1.40), p<0.0001.

To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24. If p-value for primary endpoint significant, key secondary endpoints are tested following a hierarchical closed testing procedure. 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: -0.83 (-1.05,  -0.62), p <0.0001.

To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24. If p-value for primary endpoint significant, key secondary endpoints are tested following a hierarchical closed testing procedure. 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: -27.92 (-34.45,  -21.40), p<0.0001.

To compare the change in seated systolic blood pressure (SBP) in participants with baseline seated SBP >=130 achieved with dapagliflozin versus placebo from baseline to week 8. If p-value for primary endpoint significant, key secondary endpoints are tested following a hierarchical closed testing procedure. 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: -0.86  (-3.75,  2.03), p=05583.

To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24. If p-value for primary endpoint significant, key secondary endpoints are tested following a hierarchical closed testing procedure. 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: -14.82 (-21.73, -7.90), p<0.0001.

To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. If p-value for primary endpoint significant, key secondary endpoints are tested following a hierarchical closed testing procedure. Logistic regression analysis of responses based on methodology of Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu, with adjustment for baseline value and stratum. Outcome measure type Least Squares Mean represents adjusted percent. Difference from placebo: 18.7 (11.1, 26.4), p<0.0001.

Arms	Assigned Interventions
Active Comparator: 1 Dapagliflozin 10 mg tablet	Drug: Dapagliflozin 10 mg tablet, oral, once daily, 48 weeks
Placebo Comparator: 2 Matching placebo tablet	Drug: Placebo Matching placebo tablet

Dapagliflozin DPPIV inhibitor add-on study

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

D1690C00010_Clinical_Study_Report_Synopsis

D1690C00010_Revised_CSP1_and_Amdt_1_Priv_Redacted

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator