A Phase III Study of BMS-512148 (Dapagliflozin) in patients with Type 2 Diabetes who are not well controlled with Diet and Exercise

Study identifier:MB102-013 LT

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Type 2 Diabetes

Phase

Phase 3

Healthy volunteers

Study drug

Dapagliflozin, Dapagliflozin placebo, Metformin

Sex

All

Actual Enrollment

1067

Study type

Interventional

Age

18 Years - 77 Years

Date

Study Start Date: 01 Sept 2007

Primary Completion Date: 01 Feb 2009

Study Completion Date: 01 Jul 2010

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2015 by AstraZeneca Pharmaceuticals

Collaborators

Astra Zeneca

Inclusion and exclusion criteria

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

Location

Newark Physician Associates

Newark, OH, United States, 43055

Location

Banksville Medical, Pc

Pittsburgh, PA, United States, 15216

Location

Southeastern Research Associates, Inc.

Taylors, SC, United States, 29687

Location

Ritchken & First M.D.'S

San Diego, CA, United States, 92117

Location

William L. Gray, Md

Spokane, WA, United States, 99216

Location

Nevada Alliance Against Diabetes

Las Vegas, NV, United States, 89101

Location

Woodlake Research

Chesterfield, MO, United States, 63017

Location

Sam Clinical Research Center

San Antonio, TX, United States, 78229

Arms	Assigned Interventions
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: Dapagliflozin Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks Other Name: 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: Dapagliflozin Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks Other Name: 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: Dapagliflozin Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks Other Name: 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: Dapagliflozin Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks Other Name: 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: Dapagliflozin Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks Other Name: 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: Dapagliflozin Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks Other Name: 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: Dapagliflozin Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks Other Name: 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: 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: Dapagliflozin Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks Other Name: BMS-512148

Documents available

BMS Clinical Trials Disclosure
Download
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Download
MB102013_Clinical_Study_Protocol
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Boaz Hirshberg

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Newark Physician Associates

Banksville Medical, Pc

Southeastern Research Associates, Inc.

Ritchken & First M.D.'S

William L. Gray, Md

Nevada Alliance Against Diabetes

Woodlake Research

Sam Clinical Research Center

BMS Clinical Trials Disclosure

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

MB102013_Clinical_Study_Protocol

Trial Results Summaries