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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

Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin

Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin

The purpose is to determine if after  24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.

Phase III Insulin Add-On Asia Regional Program - ST

NCT ID

Therapeutic Area

Local Institution

A 24-week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate Efficacy and Safety of Dapagliflozin Added to Therapy of Asian Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin

The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c, %) from baseline to Week 24 will be reported for each arm.

Age Categorical

Age Continuous

Gender, Male/Female

The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm.

All randomized participants with non-missing baseline and at least one post-baseline value

Adjusted mean change in HbA1c from baseline to Week 24

The adjusted mean change from baseline to 24 weeks in Fasting Plasma Glucose (FPG) was reported for each arm in milligrams per deciliter (mg/dL).

Adjusted mean change in fasting plasma glucose (FPG) from baseline to Week 24

Adjusted mean change in body weight from baseline to week 24 was reported for each arm in kilograms (kg).

Adjusted mean change in body weight from baseline to week 24

The adjusted mean change in absolute calculated mean Total Daily Dose of Insulin (TDDI) from baseline to week 24 was reported for each arm in International Units (IU).

Adjusted mean change in absolute calculated mean total daily dose of insulin (TDDI) from baseline to week 24

Treatment

Follow-up

477 participants were enrolled; 313 entered lead-in period; 272 participants were randomized to a treatment group. Of the 205 participants not randomized to a treatment group: 190 No longer met study criteria, 11 withdrew consent, 2 were lost to follow-up, and 2 were removed for administrative reasons.

Anna Maria Langkilde

The adjusted mean change from baseline to 24 weeks in Fasting Plasma Glucose (FPG) will be reported for each arm in milligrams per deciliter (mg/dL).

Adjusted mean change in body weight from baseline to week 24 will be reported for each arm in kilograms (kg).

The adjusted mean change in absolute calculated mean Total Daily Dose of Insulin (TDDI) from baseline to week 24 will be reported for each arm in International Units (IU).

Arms	Assigned Interventions
Experimental: Group 1: Dapagliflozin Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin	Drug: Dapagliflozin Tablet Other Name: BMS-512148
Placebo Comparator: Group 2: Dapagliflozin Placebo Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin	Drug: Dapagliflozin Placebo Tablet

Phase III Insulin Add-On Asia Regional Program - ST

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