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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 (5 mg) + Metformin XR (up to 2000 mg)

The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with monotherapy dapagliflozin or metformin XR. The safety of this treatment will also be studied

An efficacy & safety study of BMS-512148 in combination with metformin extended release tablets

NCT ID

Therapeutic Area

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

Endocrine Associates

Spartanburg Medical Research

Local Institution

Commonwealth Primary Care, Pc / Fleetwood Clinical Research

Middle Georgia Drug Study Center, Llc

Fpa Clinical Research

Village Family Practice

Wells Institute For Health Awareness

Newark Physician Associates

Hill Country Medical Associates

Hudson Valley Clinical Research Center

Non-Invasive Cardiovascular, Pa

Clinical Therapeutics Corporation

Covenant Clinical Research, Pa

Biomedical Research Associates, Llc

Deerbrook Medical Associates

Metrolina Medical Research

Safe Harbor Clinical Research

Southwest Clinical Research Center, Llc

S.A.M. Clinical Research Center

Middle Tennessee Clinical Research

Texas Center For Drug Development

Inst. Of Clin. Research At The Diabetes Cntr. Of The Sw

Community Health Care, Inc.

Willamette Valley Clinical Studies

Clinical Research Advantage, Inc.

Crescent Medical Research

Holston Medical Group

Southeastern Research Associates, Inc.

Valley Research

Excel Clinical Research, Llc

John Muir Physician Network Clinical Research Center

Southland Clinical Research Center, Inc.

Integris Family Care Yukon

Central Florida Clinical Trials, Inc.

Florida Research Network, Llc

Cedar Crosse Research Center

Mercy Medical Group/Dba Woodlake Research

Nextphase Clinical Trials, Inc.

Winston Technology Research, Llc

Greystone Medical Research, Llc

Integris Family Care South Penn

Physician Research, Inc.

Jackson Clinic

Gilbert Medical Research, Llc

A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination with Metformin as Initial Therapy as Compared with Dapagliflozin Monotherapy and Metformin Monotherapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control

Age Continuous

Age, Customized

Gender, Customized

Race/Ethnicity, Customized

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

HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. 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. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double- blind period.

All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)

Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. 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. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the double-blind period.

All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)

Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants estimated by modified logistic regression model.

Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])

HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. 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. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.

All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF) in subjects with baseline HbA1c ≥ 9%

Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) in Subjects with Baseline HbA1c ≥ 9% at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. 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. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.

Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])

All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF) in subjects with BMI ≥ 27 kg/m2

Adjusted Mean Change From Baseline in Total Body Weight (kg) in Subjects with Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])

Overall Study

Anna Maria Langkilde

Arms	Assigned Interventions
Experimental: Arm 1 Dapagliflozin (5 mg) + Metformin XR (up to 2000 mg)	Drug: Dapagliflozin Tablets, Oral, Once daily, 24 weeks Other Name: BMS-512148 Drug: Metformin XR Tablets, Oral, Once daily, 24 weeks
Experimental: Arm 2 Dapagliflozin (5 mg)	Drug: Dapagliflozin Tablets, Oral, Once daily, 24 weeks Other Name: BMS-512148
Active Comparator: Arm 3 Metformin XR (500 mg up to 2000 mg)	Drug: Metformin XR Tablets, Oral, Once daily, 24 weeks

An efficacy & safety study of BMS-512148 in combination with metformin extended release tablets

Official Title

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

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