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A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dapagliflozin

Placebo

Metformin

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes Mellitus, Type 2, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases, Metformin, Hypoglycemic Agents, Pharmacologic Actions, Physiological Effects of Drugs

Eligibility Criteria

18 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria

Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
C-peptide ≥1.0 ng/mL
Body mass index ≤45.0 kg/m^2
Serum creatinine level <1.50 mg/dL for men or <1.40 mg/dL for women.

Key Exclusion Criteria

Aspartate aminotransferase and/or alanine aminotransferase level >3.0 times the upper limit of normal
Serum total bilirubin level >2 mg/dL
Creatinine kinase level >3 times upper limit of normal
Symptoms of severely uncontrolled diabetes
Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women
Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo + Metformin

Dapagliflozin, 2.5 mg + Metformin

Dapagliflozin, 5 mg + Metformin

Dapagliflozin, 10 mg + Metformin

Arm Description

Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

Outcomes

Primary Outcome Measures

Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) 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.

Secondary Outcome Measures

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

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. 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.

Adjusted Mean Change From Baseline in Total Body Weight 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.

Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% 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.

Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized participants who received treatment and had a baseline HbA1c > 9.0%. Data after rescue medication were 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.

Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (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 Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted for baseline HbA1c. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication were 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.

Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured 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.

Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% 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. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.

Full Information

NCT ID

NCT00528879

First Posted

September 11, 2007

Last Updated

September 30, 2015

Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00528879

Brief Title

A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Diabetes Mellitus, Type 2, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases, Metformin, Hypoglycemic Agents, Pharmacologic Actions, Physiological Effects of Drugs

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

915 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo + Metformin

Arm Type

Placebo Comparator

Arm Description

Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

Arm Title

Dapagliflozin, 2.5 mg + Metformin

Arm Type

Experimental

Arm Description

Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

Arm Title

Dapagliflozin, 5 mg + Metformin

Arm Type

Experimental

Arm Description

Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

Arm Title

Dapagliflozin, 10 mg + Metformin

Arm Type

Experimental

Arm Description

Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

Intervention Type

Drug

Intervention Name(s)

Dapagliflozin

Other Intervention Name(s)

BMS-512148

Intervention Description

Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

Open-label metformin administered as ≥1500 mg per day for up to 102 weeks

Primary Outcome Measure Information:

Title

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

Description

Time Frame

From Baseline to Week 24

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

From Baseline to Week 24

Title

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

Description

Time Frame

From Baseline to Week 24

Title

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

Description

Time Frame

From Baseline to Week 24

Title

Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])

Description

Time Frame

From Baseline to Week 24

Title

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

Description

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.

Time Frame

From Baseline to Week 24

Title

Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])

Description

Time Frame

From Baseline to Week 24

Title

Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])

Description

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured 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.

Time Frame

From Baseline to Week 1

Title

Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF])

Description

Time Frame

From Baseline to Week 24

Other Pre-specified Outcome Measures:

Title

Number of Participants With Adverse Events (AEs), Hypoglycemia Events, Related AEs, Death as Outcome, Serious AEs (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs Leading to Discontinuation, and Hypoglycemia Events Leading to Discontinuation

Description

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Events captured from baseline to last dose plus 4 days for AEs and plus 30 days for SAEs during the double-blind 12-week period. Data after rescue included.

Time Frame

From Baseline to end of Long-term Period (Week 102)

Title

Number of Participants With Laboratory Test Results Meeting the Criteria for Laboratory Abnormality

Description

BUN=blood urea nitrogen; preRX=pretreatment; ULN=upper limit of normal; AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Phosphorus, inorganic (low): ages 17-65 years, ≤1.8 mg/dL; ages≥66 years, ≤2.1 mg/dL. Phosphorus, inorganic (high): ages 17-65 years, ≥5.6 mg/dL; ages≥66 years, ≥5.6 mg/dL. Phosphorus, inorganic (low) ≤1.8 mg/dL if age 17-65 or ≤2.1 mg/dL if age ≥66. Calcium, total (high): ≥1 mg/dL from ULN and ≥0.5 mg/dL from preRx value.

Time Frame

Day 1 to Week 102

Title

Number of Participants With Changes in Baseline in Electrocardiogram Findings at Week 102 (Last Observation Carried Forward [LOCF])

Description

12-Lead electrocardiograms (ECGs) were performed at entry into lead-in period Day -7 visit and Week 24/dnd of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter. Data after rescue included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available.

Time Frame

Baseline to Week 102

Title

Mean Changes From Baseline in Seated Systolic Blood Pressure

Description

Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. 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.

Time Frame

From Baseline to Week 102

Title

Mean Changes From Baseline in Seated Diastolic Blood Pressure

Description

Time Frame

From Baseline to Week 102

Title

Number of Participants With Orthostatic Hypotension

Description

Orthostatic hypotension was defined as a decrease from supine to standing blood pressure of >20 mm Hg in systolic blood pressure or >10 mm Hg in diastolic blood pressure.

Time Frame

From Baseline to Week 102

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

77 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks C-peptide ≥1.0 ng/mL Body mass index ≤45.0 kg/m^2 Serum creatinine level <1.50 mg/dL for men or <1.40 mg/dL for women. Key Exclusion Criteria Aspartate aminotransferase and/or alanine aminotransferase level >3.0 times the upper limit of normal Serum total bilirubin level >2 mg/dL Creatinine kinase level >3 times upper limit of normal Symptoms of severely uncontrolled diabetes Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Research Advantage / Desert Clinical Res, Llc

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85282

Country

United States

Facility Name

Medical Group Of Encino

City

Encino

State/Province

California

ZIP/Postal Code

91436

Country

United States

Facility Name

Valley Research

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Randall Shue, D.O.

City

Los Angeles

State/Province

California

ZIP/Postal Code

90023

Country

United States

Facility Name

Diabetes Medical Center Of California

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

Ritchken & First M.D.'S

City

San Diego

State/Province

California

ZIP/Postal Code

92117

Country

United States

Facility Name

Encompass Clinical Research

City

Spring Valley

State/Province

California

ZIP/Postal Code

91978

Country

United States

Facility Name

Raikhel, Marina

City

Torrance

State/Province

California

ZIP/Postal Code

90505

Country

United States

Facility Name

Express Care Clinical Res

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80909

Country

United States

Facility Name

Denver Internal Medicine

City

Denver

State/Province

Colorado

ZIP/Postal Code

80209

Country

United States

Facility Name

New West Physicians

City

Golden

State/Province

Colorado

ZIP/Postal Code

80401

Country

United States

Facility Name

Central Florida Clinical Trials, Inc.

City

Altamonte Springs

State/Province

Florida

ZIP/Postal Code

32701

Country

United States

Facility Name

Family Care Associates Of Nw Florida

City

Chipley

State/Province

Florida

ZIP/Postal Code

32428

Country

United States

Facility Name

Health Partners Research Foundation

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

56440

Country

United States

Facility Name

Woodlake Research

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

Facility Name

Nevada Alliance Against Diabetes

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89101

Country

United States

Facility Name

Diabetes & Endocrinology Consultants, Pc

City

Morehead City

State/Province

North Carolina

ZIP/Postal Code

28557

Country

United States

Facility Name

Newark Physician Associates

City

Newark

State/Province

Ohio

ZIP/Postal Code

43055

Country

United States

Facility Name

Integris Family Care S. Penn

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73159

Country

United States

Facility Name

Cumberland Valley Endocrinology Center, Llc

City

Carlisle

State/Province

Pennsylvania

ZIP/Postal Code

17013

Country

United States

Facility Name

Banksville Medical Pc

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15216

Country

United States

Facility Name

Palmetto Clinical Research

City

Summerville

State/Province

South Carolina

ZIP/Postal Code

29485

Country

United States

Facility Name

Southeastern Research Assoc

City

Taylors

State/Province

South Carolina

ZIP/Postal Code

29687

Country

United States

Facility Name

Texas Center For Drug Development, P.A.

City

Houston

State/Province

Texas

ZIP/Postal Code

77081

Country

United States

Facility Name

Diabetes & Glandular Disease Research Associates, Inc.

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

S.A.M. Clinical Research Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Optimum Clinical Research

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84102

Country

United States

Facility Name

Office Of Dr. Gray

City

Spokane

State/Province

Washington

ZIP/Postal Code

99216

Country

United States

Facility Name

Local Institution

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1034

Country

Argentina

Facility Name

Local Institution

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1429

Country

Argentina

Facility Name

Local Institution

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

C1056ABJ

Country

Argentina

Facility Name

Local Institution

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

C1425AGC

Country

Argentina

Facility Name

Local Institution

City

Ciudad Auton.

State/Province

Buenos Aires

ZIP/Postal Code

C1505CWB

Country

Argentina

Facility Name

Local Institution

City

Ciudad Auton

State/Province

Buenos Aires

ZIP/Postal Code

C1408INH

Country

Argentina

Facility Name

Local Institution

City

Mar Del Plata

State/Province

Buenos Aires

ZIP/Postal Code

7600

Country

Argentina

Facility Name

Local Institution

City

Zarate

State/Province

Buenos Aires

ZIP/Postal Code

2800

Country

Argentina

Facility Name

Local Institution

City

Villa Carlos Paz

State/Province

Cordoba

ZIP/Postal Code

5152

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

1431

Country

Argentina

Facility Name

Local Institution

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Local Institution

City

Fortaleza

State/Province

Ceara

ZIP/Postal Code

60021

Country

Brazil

Facility Name

Local Institution

City

Itajuba

State/Province

Minas Gerais

ZIP/Postal Code

37502

Country

Brazil

Facility Name

Local Institution

City

Belem

State/Province

Para

ZIP/Postal Code

66073

Country

Brazil

Facility Name

Local Institution

City

Caxias Do Sul

State/Province

Rio Grande Do Sul

ZIP/Postal Code

95070

Country

Brazil

Facility Name

Local Institution

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90020090

Country

Brazil

Facility Name

Local Institution

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035

Country

Brazil

Facility Name

Local Institution

City

Marilia

State/Province

Sao Paulo

ZIP/Postal Code

17519

Country

Brazil

Facility Name

Local Institution

City

Rio De Janeiro

ZIP/Postal Code

20211

Country

Brazil

Facility Name

Local Institution

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2R 0X7

Country

Canada

Facility Name

Local Institution

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 2H4

Country

Canada

Facility Name

Local Institution

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 3P4

Country

Canada

Facility Name

Local Institution

City

Bathurst

State/Province

New Brunswick

ZIP/Postal Code

E2A 4X7

Country

Canada

Facility Name

Local Institution

City

Mount Pearl

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1N 1W7

Country

Canada

Facility Name

Local Institution

City

St-John

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1E 2E2

Country

Canada

Facility Name

Local Institution

City

Sarnia

State/Province

Ontario

ZIP/Postal Code

N7T 4X3

Country

Canada

Facility Name

Local Institution

City

Thornhill

State/Province

Ontario

ZIP/Postal Code

L4J 8L7

Country

Canada

Facility Name

Local Institution

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4R 2G4

Country

Canada

Facility Name

Local Institution

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9W 4L6

Country

Canada

Facility Name

Local Institution

City

Charlottetown

State/Province

Prince Edward Island

ZIP/Postal Code

C1A 5Y9

Country

Canada

Facility Name

Local Institution

City

Drummondville

State/Province

Quebec

ZIP/Postal Code

J2B 7T1

Country

Canada

Facility Name

Local Institution

City

Granby

State/Province

Quebec

ZIP/Postal Code

J2G 8Z9

Country

Canada

Facility Name

Local Institution

City

L'Ancienne Lorette

State/Province

Quebec

ZIP/Postal Code

G2E 2X1

Country

Canada

Facility Name

Local Institution

City

Mirabel

State/Province

Quebec

ZIP/Postal Code

J7J 2K8

Country

Canada

Facility Name

Local Institution

City

St-Leonard

State/Province

Quebec

ZIP/Postal Code

H1S 3A9

Country

Canada

Facility Name

Local Institution

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 3H3

Country

Canada

Facility Name

Local Institution

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 7H9

Country

Canada

Facility Name

Local Institution

City

State/Province

Distrito Federal

ZIP/Postal Code

11800

Country

Mexico

Facility Name

Local Institution

City

Guadalajara

State/Province

Distrito Federal

ZIP/Postal Code

44670

Country

Mexico

Facility Name

Local Institution

City

Zapopan

State/Province

Distrito Federal

ZIP/Postal Code

45150

Country

Mexico

Facility Name

Local Institution

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44650

Country

Mexico

Facility Name

Local Institution

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44670

Country

Mexico

Facility Name

Local Institution

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Local Institution

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64710

Country

Mexico

Facility Name

Local Institution

City

Monterrrey

State/Province

Nuevo Leon

ZIP/Postal Code

64700

Country

Mexico

Facility Name

Local Institution

City

Tampico

State/Province

Tamaulipas

ZIP/Postal Code

89109

Country

Mexico

Facility Name

Local Institution

City

Durango

ZIP/Postal Code

64710

Country

Mexico

12. IPD Sharing Statement

Citations:

PubMed Identifier

33368935

Citation

Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25.

Results Reference

derived

PubMed Identifier

31364269

Citation

Bailey CJ, Del Prato S, Wei C, Reyner D, Saraiva G. Durability of glycaemic control with dapagliflozin, an SGLT2 inhibitor, compared with saxagliptin, a DPP4 inhibitor, in patients with inadequately controlled type 2 diabetes. Diabetes Obes Metab. 2019 Nov;21(11):2564-2569. doi: 10.1111/dom.13841. Epub 2019 Aug 26.

Results Reference

derived

PubMed Identifier

27461213

Citation

Mellander A, Billger M, Johnsson E, Traff AK, Yoshida S, Johnsson K. Hypersensitivity Events, Including Potentially Hypersensitivity-Related Skin Events, with Dapagliflozin in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis. Clin Drug Investig. 2016 Nov;36(11):925-933. doi: 10.1007/s40261-016-0438-3.

Results Reference

derived

PubMed Identifier

26894924

Citation

Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.

Results Reference

derived

PubMed Identifier

23425012

Citation

Bailey CJ, Gross JL, Hennicken D, Iqbal N, Mansfield TA, List JF. Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trial. BMC Med. 2013 Feb 20;11:43. doi: 10.1186/1741-7015-11-43. Erratum In: BMC Med. 2013;11:193.

Results Reference

derived

PubMed Identifier

20609968

Citation

Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Jun 26;375(9733):2223-33. doi: 10.1016/S0140-6736(10)60407-2.

Results Reference

derived

Learn more about this trial

A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

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A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

Type 2 Diabetes

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial