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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 intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.

Evaluation of Safety and Efficacy of Dapagliflozin in subjects with Type 2 Diabetes who have Inadequate Glycaemic Control on background combination of Metformin and Sulfonylurea

10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period

matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period

Research Site

A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study with a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg once daily in Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on a background combination of Metformin and Sulfonylurea

Age Continuous

Gender, Male/Female

Race/Ethnicity, Customized

Body Weight

Study Specific Characteristic

Body Mass Index

Glycosylated hemoglobin A1c (HbA1c)

Fasting Plasma Glucose

Fasting C-Peptide

Full Analysis Set defined as all randomized participants (as randomized) who received at least one dose of study medication during the 24-week short-term double blind treatment period who have a non-missing baseline value and at least one post-baseline value for at least one efficacy variable to be analyzed at week 24.

For participants who did not complete 8 and/or 24 weeks, respectively, last observation carried forward (LOCF) was used for analyses of secondary endpoints. All endpoints were evaluated by excluding data after rescue.

To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.

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 values

Adjusted mean change from baseline in HbA1c levels

To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo

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

Adjusted mean change from baseline in FPG

To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo

Adjusted mean change from baseline in total body weight

To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo

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

Proportion of participants with HbA1c value < 7.0% at week 24 (LOCF)

To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo

Full Analysis Set, participants with non-missing baseline and week 8 (LOCF) values

Adjusted mean change from baseline in seated systolic blood pressure

Overall Study

During enrollment, diet and life-style advice was given to participants and was reinforced during a placebo lead-in period. Dose of anti-hyperglycemic combination therapy of metformin >= 1500 mg/day and maximum tolerated dose which must be at least half the maximum dose of sulfonylurea for at least 8 weeks prior to enrollment were to remain stable.

Arms	Assigned Interventions
Experimental: Dapagliflozin 10 mg tablet	Drug: dapagliflozin 10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period
Placebo Comparator: matching placebo tablet	Drug: placebo matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period

Evaluation of Safety and Efficacy of Dapagliflozin in subjects with Type 2 Diabetes who have Inadequate Glycaemic Control on background combination of Metformin and Sulfonylurea

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

D1693C00005.pdf

D1693C00005_CSP

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator