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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 evaluate the effects of dapagliflozin on insulin sensitivity

Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects with Type 2 Diabetes

NCT ID

Therapeutic Area

Tablets, Oral, 5 mg, once daily, 12 weeks

Tablets, Oral, 0 mg, Once daily, 12 weeks

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Va San Diego Healthcare System

Pennington Biomedical Research Center

Temple University General Clinical Research Center

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Trial to Evaluate the Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects with Type 2 Diabetes

Age Continuous

Age, Customized

Gender, Customized

Race/Ethnicity, Customized

All randomized participants who received at least 1 dose of study medication

Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period.

All randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF)

Arms	Assigned Interventions
Experimental: Dapagliflozin	Drug: Dapagliflozin Tablets, Oral, 5 mg, once daily, 12 weeks Other Name: BMS-512148
Placebo Comparator: Placebo	Drug: Placebo Tablets, Oral, 0 mg, Once daily, 12 weeks

Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects with Type 2 Diabetes

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

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Publication

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator