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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

The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of dapagliflozin to placebo when given in oral doses.

trial to evaluate the efficacy and safety of dapagliflozin in Japanese type 2 diabetes mellitus patients

Research Site

A multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 2 trial to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with type 2 diabetes mellitus who have inadequate glycemic control

Age Continuous

Gender, Male/Female

Japanese

Race/Ethnicity, Customized

HBA1C

Study Specific Characteristic

Full Analysis Set defined as all randomised 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 period. 

If an efficacy measurement was unavailable at the time point for analysis, last observation was carried forward (LOCF).

The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.

The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)

Full Analysis Set, participants with non-missing baseline and Week 12 (LOCF) values

Adjusted mean change in HbA1c levels

Change in fasting plasma glucose from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.

The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 

Adjusted mean change in fasting plasma glucose

Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin <7%, after 12 weeks of double-blind therapy

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

Full Analysis Set, participants with non-missing baseline and week 12 (LOCF) values

Arms	Assigned Interventions
Experimental: 1 1mg dapagliflozin	Drug: Dapagliflozin once daily, 12 weeks
Experimental: 2 2.5mg dapagliflozin	Drug: Dapagliflozin once daily, 12 weeks
Experimental: 3 5mg dapagliflozin	Drug: Dapagliflozin once daily, 12 weeks
Experimental: 4 10mg dapagliflozin	Drug: Dapagliflozin once daily, 12 weeks
Placebo Comparator: 5 Placebo	Drug: Placebo once daily, 12 weeks

trial to evaluate the efficacy and safety of dapagliflozin in Japanese type 2 diabetes mellitus patients

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-D1692C00005.pdf

D1692C00005 Clinical Study Protocol

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator