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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: Dapagliflozin (Drug); Dapagliflozin placebo (Drug); Metformin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1

Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (Last Observation Carried Forward [LOCF]): Group 2

Secondary outcome:

Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1

Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 2

Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1

Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 2

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

Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 2

Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])

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

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])

Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])

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)

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)

Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)

Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)

Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])

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.

Eligibility

Minimum age: 18 Years. Maximum age: 77 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Local Institution, Aguascalientes 20230, Mexico

Local Institution, Durango 34000, Mexico

Local Institution, Kursk 305035, Russian Federation

Local Institution, Moscow 115093, Russian Federation

Local Institution, Saint-Petersburg 191015, Russian Federation

Local Institution, Smolensk 214019, Russian Federation

Local Institution, St. Petersburg 195257, Russian Federation

Local Institution, St.Petersburg 195112, Russian Federation

Local Institution, Yaroslaval 150003, Russian Federation

Local Institution, Calgary, Alberta T2R 0X7, Canada

43rd Medical Associates, P.C., Phoenix, Arizona 85051, United States

Clin Res Advantage, Inc/East Valley Family Physicians, Plc, Tempe, Arizona 85282, United States

Clinical Research Advantage, Inc, Tempe, Arizona 85282, United States

Local Institution, Tijuana, Baja California 22320, Mexico

Local Institution, Kelowna, British Columbia V1Y 2H4, Canada

Valley Research, Fresno, California 93720, United States

Cherlin, Richard, Los Gatos, California 95032, United States

Ritchken & First M.D.'S, San Diego, California 92117, United States

Torrance Clinical Research, Torrance, California 90717, United States

Aurora Family Medicine Center, P.C., Aurora, Colorado 80012, United States

Expresscare Clinical Research, Colorado Springs, Colorado 80909, United States

Center For Internal Medicine, Denver, Colorado 80209, United States

Denver Internal Medicine Group, Denver, Colorado 80209, United States

Local Institution, Guadalajara, Distrito Federal 44670, Mexico

Local Institution, Mexico, D. F., Distrito Federal 06726, Mexico

Central Florida Clinical Trials, Altamonte Springs, Florida 32701, United States

Family Care Associates, Chipley, Florida 32428, United States

Westside Center For Clinical Research, Jacksonville, Florida 32205, United States

Panhandle Family Care Associates, Marianna, Florida 32446, United States

Local Institution, Guadalajara, Jalisco 44100, Mexico

Local Institution, Guadalajara, Jalisco 44600, Mexico

Local Institution, Guadalajara, Jalisco 44680, Mexico

Louisiana Heart Center, Slidell, Louisiana 70458, United States

Local Institution, Winnipeg, Manitoba R3E 3P4, Canada

Local Institution, Morelia, Michioacan 58070, Mexico

Jackson, Danny W., Rolling Fork, Mississippi 39159, United States

Woodlake Research, Chesterfield, Missouri 63017, United States

Nevada Alliance Against Diabetes, Las Vegas, Nevada 89101, United States

Local Institution, Bathurst, New Brunswick E2A 4X7, Canada

Local Institution, Moncton, New Brunswick E1G 1A7, Canada

Slocum-Dickson Medical Group, Pllc, New Hartford, New York 13413, United States

Internist Associates Of Central New York, P. C., Syracuse, New York 13210, United States

Southgate Medical Group, West Seneca, New York 14224, United States

Local Institution, Mount Pearl, Newfoundland and Labrador A1N 1W7, Canada

Local Institution, St-John, Newfoundland and Labrador A1E 2E2, Canada

Local Institution, St. John'S, Newfoundland and Labrador A1A 3R5, Canada

Local Institution, Monterrey, Nuevo Leon 64060, Mexico

Local Institution, Monterrrey, Nuevo Leon 64700, Mexico

Providence Health Partners, Dayton, Ohio 45439, United States

Newark Physician Associates, Newark, Ohio 43055, United States

Physician Research, Inc., Zanesville, Ohio 43701, United States

Gilbert Medical Research, Llc, Bethany, Oklahoma 73008, United States

Integris Family Care Yukon, Yukon, Oklahoma 73109, United States

Local Institution, Oakville, Ontario L6H 3P1, Canada

Local Institution, Sarnia, Ontario N7T 4X3, Canada

Local Institution, Thornhill, Ontario L4J 8L7, Canada

Local Institution, Toronto, Ontario M4R 2G4, Canada

Local Institution, Toronto, Ontario M9W 4L6, Canada

Banksville Medical, Pc, Pittsburgh, Pennsylvania 15216, United States

Local Institution, Charlottetown, Prince Edward Island C1A 5Y9, Canada

Local Institution, Drummondville, Quebec J2B 7T1, Canada

Local Institution, Granby, Quebec J2G 8Z9, Canada

Local Institution, L'Ancienne Lorette, Quebec G2E 2X1, Canada

Local Institution, Mirabel, Quebec J7J 2K8, Canada

Local Institution, St-Leonard, Quebec H1S 3A9, Canada

Local Institution, Saskatoon, Saskatchewan S7K 3H3, Canada

Local Institution, Saskatoon, Saskatchewan S7K 7H9, Canada

Southeastern Research Associates, Inc., Taylors, South Carolina 29687, United States

Holston Medical Group, Kingsport, Tennessee 37660, United States

Village Family Practice, Houston, Texas 77024, United States

Abbott Clinical Research Group, Inc., San Antonio, Texas 78224, United States

Sam Clinical Research Center, San Antonio, Texas 78229, United States

Taylor/Wade Medical, Bountiful, Utah 84010, United States

J. Lewis Research, Inc, Salt Lake City, Utah 84121, United States

Optimum Clinical Research, Inc., Salt Lake City, Utah 84102, United States

Tidewater Integrated Medical Research, Virginia Beach, Virginia 23454, United States

William L. Gray, Md, Spokane, Washington 99216, United States

Local Institution, Merida, Yucatan 97070, Mexico

Additional Information

BMS Clinical Trials Disclosure

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

Starting date: September 2007
Last updated: April 15, 2014

Page last updated: August 23, 2015

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