A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

September 30, 2015 updated by: AstraZeneca

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

The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes who have never been treated with medication or have been taking medication for less than 24 weeks since their original diabetes diagnosis. The safety of this treatment will also be studied.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All eligible participants will receive single-blind placebo medication during the 2-week lead-in period. All participants may receive additional open-label treatment with metformin, 500-2000 mg, as needed for rescue, based on protocol specific criteria.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1067

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2R 0X7
        • Local Institution
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 2H4
        • Local Institution
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Local Institution
    • New Brunswick
      • Bathurst, New Brunswick, Canada, E2A 4X7
        • Local Institution
      • Moncton, New Brunswick, Canada, E1G 1A7
        • Local Institution
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
        • Local Institution
      • St-John, Newfoundland and Labrador, Canada, A1E 2E2
        • Local Institution
      • St. John'S, Newfoundland and Labrador, Canada, A1A 3R5
        • Local Institution
    • Ontario
      • Oakville, Ontario, Canada, L6H 3P1
        • Local Institution
      • Sarnia, Ontario, Canada, N7T 4X3
        • Local Institution
      • Thornhill, Ontario, Canada, L4J 8L7
        • Local Institution
      • Toronto, Ontario, Canada, M4R 2G4
        • Local Institution
      • Toronto, Ontario, Canada, M9W 4L6
        • Local Institution
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 5Y9
        • Local Institution
    • Quebec
      • Drummondville, Quebec, Canada, J2B 7T1
        • Local Institution
      • Granby, Quebec, Canada, J2G 8Z9
        • Local Institution
      • L'Ancienne Lorette, Quebec, Canada, G2E 2X1
        • Local Institution
      • Mirabel, Quebec, Canada, J7J 2K8
        • Local Institution
      • St-Leonard, Quebec, Canada, H1S 3A9
        • Local Institution
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 3H3
        • Local Institution
      • Saskatoon, Saskatchewan, Canada, S7K 7H9
        • Local Institution
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Local Institution
      • Durango, Mexico, 34000
        • Local Institution
    • Baja California
      • Tijuana, Baja California, Mexico, 22320
        • Local Institution
    • Distrito Federal
      • Guadalajara, Distrito Federal, Mexico, 44670
        • Local Institution
      • Mexico, D. F., Distrito Federal, Mexico, 06726
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44100
        • Local Institution
      • Guadalajara, Jalisco, Mexico, 44600
        • Local Institution
      • Guadalajara, Jalisco, Mexico, 44680
        • Local Institution
    • Michioacan
      • Morelia, Michioacan, Mexico, 58070
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64060
        • Local Institution
      • Monterrrey, Nuevo Leon, Mexico, 64700
        • Local Institution
    • Yucatan
      • Merida, Yucatan, Mexico, 97070
        • Local Institution
  • Russian Federation
      • Kursk, Russian Federation, 305035
        • Local Institution
      • Moscow, Russian Federation, 115093
        • Local Institution
      • Saint-Petersburg, Russian Federation, 191015
        • Local Institution
      • Smolensk, Russian Federation, 214019
        • Local Institution
      • St. Petersburg, Russian Federation, 195257
        • Local Institution
      • St.Petersburg, Russian Federation, 195112
        • Local Institution
      • Yaroslaval, Russian Federation, 150003
        • Local Institution
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85051
        • 43rd Medical Associates, P.C.
      • Tempe, Arizona, United States, 85282
        • Clinical Research Advantage, Inc
      • Tempe, Arizona, United States, 85282
        • Clin Res Advantage, Inc/East Valley Family Physicians, Plc
    • California
      • Fresno, California, United States, 93720
        • Valley Research
      • Los Gatos, California, United States, 95032
        • Cherlin, Richard
      • San Diego, California, United States, 92117
        • Ritchken & First M.D.'S
      • Torrance, California, United States, 90717
        • Torrance Clinical Research
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Aurora Family Medicine Center, P.C.
      • Colorado Springs, Colorado, United States, 80909
        • Expresscare Clinical Research
      • Denver, Colorado, United States, 80209
        • Denver Internal Medicine Group
      • Denver, Colorado, United States, 80209
        • Center For Internal Medicine
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Central Florida Clinical Trials
      • Chipley, Florida, United States, 32428
        • Family Care Associates
      • Jacksonville, Florida, United States, 32205
        • Westside Center for Clinical Research
      • Marianna, Florida, United States, 32446
        • Panhandle Family Care Associates
    • Louisiana
      • Slidell, Louisiana, United States, 70458
        • Louisiana Heart Center
    • Mississippi
      • Rolling Fork, Mississippi, United States, 39159
        • Jackson, Danny W.
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Woodlake Research
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • Nevada Alliance Against Diabetes
    • New York
      • New Hartford, New York, United States, 13413
        • Slocum-Dickson Medical Group, Pllc
      • Syracuse, New York, United States, 13210
        • Internist Associates Of Central New York, P. C.
      • West Seneca, New York, United States, 14224
        • Southgate Medical Group
    • Ohio
      • Dayton, Ohio, United States, 45439
        • Providence Health Partners
      • Newark, Ohio, United States, 43055
        • Newark Physician Associates
      • Zanesville, Ohio, United States, 43701
        • Physician Research, Inc.
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
        • Gilbert Medical Research, Llc
      • Yukon, Oklahoma, United States, 73109
        • Integris Family Care Yukon
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15216
        • Banksville Medical, Pc
    • South Carolina
      • Taylors, South Carolina, United States, 29687
        • Southeastern Research Associates, Inc.
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
    • Texas
      • Houston, Texas, United States, 77024
        • Village Family Practice
      • San Antonio, Texas, United States, 78229
        • Sam Clinical Research Center
      • San Antonio, Texas, United States, 78224
        • Abbott Clinical Research Group, Inc.
    • Utah
      • Bountiful, Utah, United States, 84010
        • Taylor/Wade Medical
      • Salt Lake City, Utah, United States, 84102
        • Optimum Clinical Research, Inc.
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research, Inc
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Tidewater Integrated Medical Research
    • Washington
      • Spokane, Washington, United States, 99216
        • William L. Gray, Md

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria

  • Males and females, aged 18 to 77 years
  • Type 2 diabetes with inadequate glycemic control, defined as: Group 1, hemoglobin A1c (HbA1c) ≥7% and ≤10%; Group 2, HbA1c ≥10.1% and ≤12.0%
  • Drug naive, defined as never having received prescription medications for diabetes, having received prescription medications for diabetes for <24 weeks since the original diagnosis
  • C-peptide ≥1.0 ng/mL at enrollment
  • Body Mass Index ≤ 45.0 kg/m^2 at enrollment

Key Exclusion Criteria

  • Urine albumin:creatinine ratio >1,800 mg/g
  • Aspartate aminotransferase >3*upper limit of normal (ULN)
  • Alanine aminotransferase >3*ULN
  • Serum total bilirubin >2*ULN
  • Serum creatinine ≥1.5 mg/dL for men; ≥1.4 mg/dLfor women
  • Calcium value outside of the central laboratory normal reference range
  • Positive hepatitis B surface antigen
  • Positive anti-hepatitis C virus antibody
  • Hemoglobin ≤11 g/dL for men; hemoglobin ≤10 g/dL for women
  • Creatine kinase >3*ULN
  • Abnormal free T4 values
  • History of diabetes insipidus
  • Symptoms of poorly controlled diabetes, including marked polyuria and polydipsia with greater than 10% weight loss in the 3 months prior to enrollment
  • History of diabetic ketoacidosis or hyperosmolar nonketotic coma
  • Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg
  • Any of the following within 6 months of enrollment: Myocardial infarction, cardiac surgery or revascularization, unstable angina, unstable congestive heart failure (CHF), CHF New York Heart Association Class III or IV status, transient ischemic attack or significant cerebrovascular disease, unstable or previously undiagnosed arrhythmia
  • History of unstable or rapidly progressing renal disease
  • Conditions of congenital renal glucosuria
  • Significant hepatic disease, including chronic active hepatitis and/or severe hepatic insufficiency
  • Documented history of hepatotoxicity with any medication
  • Documented history of severe hepatobiliary disease
  • History of hemoglobinopathy, with the exception of sickle cell trait, thalassemia minor, or chronic or recurrent hemolysis
  • Donation of blood or blood products to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of >400 mL of blood during the 6 weeks prior to enrollment
  • Malignancy (with the exception of treated basal cell or treated squamous cell carcinoma) within 5 years of enrollment visit
  • Known immunocompromised status, including individuals who had undergone organ transplantation or who had positive HIV results
  • Administration of any antidiabetic therapy for more than 14 days (consecutive or not) during the 12 weeks prior to enrollment
  • Administration of any antidiabetic therapy, other than any previously specified, at any dose, at any time during the 4 weeks prior to enrollment
  • Replacement or chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid taken for >4 weeks within 3 months prior to enrollment
  • History of bariatric surgery or lap-band procedure
  • Administration of sibutramine, phentermine, orlistat, rimonabant, benzphetamine, diethylpropion, methamphetamine, and/or phendimetrazine, within 30 days of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1: Dapagliflozin, 2.5 mg AM
Participants with hemoglobin A1c (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks.
Drug: Metformin
Other Names:
  • Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria
Drug: Dapagliflozin
Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks
Other Names:
  • BMS-512148
Experimental: Group 1: Dapagliflozin, 10 mg AM
Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks.
Drug: Metformin
Other Names:
  • Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria
Drug: Dapagliflozin
Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks
Other Names:
  • BMS-512148
Experimental: Group 1: Dapagliflozin 2.5 mg PM
Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks.
Drug: Metformin
Other Names:
  • Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria
Drug: Dapagliflozin
Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks
Other Names:
  • BMS-512148
Experimental: Group 1: Dapagliflozin, 5 mg PM
Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks.
Drug: Metformin
Other Names:
  • Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria
Drug: Dapagliflozin
Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks
Other Names:
  • BMS-512148
Experimental: Group 1: Dapagliflozin, 10 mg PM
Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks.
Drug: Metformin
Other Names:
  • Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria
Drug: Dapagliflozin
Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks
Other Names:
  • BMS-512148
Experimental: Group 2: Dapagliflozin, 5 mg AM
Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks.
Drug: Metformin
Other Names:
  • Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria
Drug: Dapagliflozin
Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks
Other Names:
  • BMS-512148
Experimental: Group 2: Dapagliflozin, 10 mg AM
Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks.
Drug: Metformin
Other Names:
  • Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria
Drug: Dapagliflozin
Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks
Other Names:
  • BMS-512148
Experimental: Group 1: Dapagliflozin placebo AM & PM
Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks.
Drug: Metformin
Other Names:
  • Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria
Drug: Dapagliflozin placebo
Tablets, oral, 0 mg, once daily in the morning or evening for up to 102 weeks
Experimental: Group 1: Dapaglifozon, 5 mg AM
Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks.
Drug: Metformin
Other Names:
  • Tablets, 500-2000 mg, orally as needed in any arm for rescue, based on protocol specific criteria
Drug: Dapagliflozin
Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks
Other Names:
  • BMS-512148

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1
Time Frame: Baseline to Week 24 (end of Short-term Period)
HbA1c was measured 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. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Evening dosing groups were summarized as exploratory endpoints.
Baseline to Week 24 (end of Short-term Period)
Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (Last Observation Carried Forward [LOCF]): Group 2
Time Frame: Baseline to Week 24 (end of Short-term Period)
HbA1c was measured 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. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Baseline to Week 24 (end of Short-term Period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1
Time Frame: Baseline to Week 24 (end of Short-term Period)
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized in secondary efficacy analyses. 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. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.
Baseline to Week 24 (end of Short-term Period)
Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 2
Time Frame: Baseline to Week 24 (end of Short-term Period)
Group 2 was an exploratory group, included to obtain initial efficacy and safety data. No comparator arm was included. Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. 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. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.
Baseline to Week 24 (end of Short-term Period)
Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1
Time Frame: From Baseline to Week 24 (end of Short-term Period)
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. 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.
From Baseline to Week 24 (end of Short-term Period)
Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 2
Time Frame: From Baseline to Week 24 (end of Short-term Period)
Secondary endpoints were tested using a 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.Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
From Baseline to Week 24 (end of Short-term Period)
Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1
Time Frame: Baseline to Week 1 (end of Short-term Period)
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. 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.
Baseline to Week 1 (end of Short-term Period)
Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 2
Time Frame: Baseline to Week 1
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. 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.
Baseline to Week 1
Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])
Time Frame: Baseline to Week 24 (end of Short-term Period)
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.
Baseline to Week 24 (end of Short-term Period)
Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])
Time Frame: Baseline to Week 24 (end of Short-term Period)
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. HbA1c was measured as % of hemoglobin by a central laboratory. The population included randomized patients who received treatment and had 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 double-blind study drug. In cases where time of the first dose or 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 drug. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered exploratory, included to obtain initial data. No comparator arm was included. Thus, only key safety and efficacy analyses were performed in Group 2.
Baseline to Week 24 (end of Short-term Period)
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])
Time Frame: Baseline to Week 24 (end of Short-term Period)
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. 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. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.
Baseline to Week 24 (end of Short-term Period)
Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])
Time Frame: Baseline to Week 24 (end of Short-term Period)
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.
Baseline to Week 24 (end of Short-term Period)
Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)
Time Frame: Baseline to Week 24 (end of Short-term Period)
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. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.
Baseline to Week 24 (end of Short-term Period)
Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)
Time Frame: Day 1 to Week 102 (end of Long-term Period) + 30 days
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. Includes non-SAEs and hypoglycemia with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 4 days. Includes SAEs with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 30 days.
Day 1 to Week 102 (end of Long-term Period) + 30 days
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)
Time Frame: Baseline to Week 102 (end of Long-term Period)
Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue were also included. ULN=upper limit of normal; preRX=pretreatment. Phosphorus, inorganic (high) defined as >=5.6 mg/dL for ages 17-65 years or >=5.1 mg/dL for ages >=66.
Baseline to Week 102 (end of Long-term Period)
Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)
Time Frame: Day 1 to Week 102 (end of Long-term Period)
Data after rescue was included. AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.
Day 1 to Week 102 (end of Long-term Period)
Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])
Time Frame: Baseline to Week 24 (end of Short-term Period)
12-Lead ECGs were performed at entry into lead-in period Day -7 visit and Week 24/end of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter, and data after rescue were included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.
Baseline to Week 24 (end of Short-term Period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Anna Maria Langkilde, AstraZeneca

Publications and helpful links

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General Publications

Helpful Links

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

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Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MB102-013 LT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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