Dapagliflozin and Metformin Combination for Type 2 Diabetes Control
This study aims to evaluate the effectiveness of a combination treatment using Dapagliflozin and Metformin in reducing Hemoglobin A1c levels in individuals with Type 2 Diabetes over a period of 24 weeks.
Dapagliflozin
+ Metformin XR
+ metformin HCl Modified Release matching Placebo
Diabetes Mellitus+3
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: April 1, 2009
Actual date on which the first participant was enrolled.The primary purpose of this study is to compare the change from baseline in hemoglobin A1C achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin XR monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral administration of double-blind treatment. The safety of treatment with dapagliflozin will also be assessed in this study
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1093 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 77 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Treatment naive males and females, \>= 18 years old and \<= 77 years old, with type 2 diabetes mellitus * Subjects must have central laboratory pre-randomization hemoglobin A1C \>= 7.5 and \<= 12.0% * C-peptide \>= 1.0 ng/mL (0.34 nmol/L) * Body Mass Index \<= 45 kg/m2 * Must be able to perform self monitoring of blood glucose Exclusion Criteria: * aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>3X\*upper limit of normal (ULN) * Serum Total bilirubin \>2 mg/dL (34.2 µmol/L) * Creatinine kinase \>3\*ULN * Serum creatinine \>= 1.50 mg/dL (133 µmol/L) for male subjects, \>= 1.40 mg/dL (124 µmol/L) for female subjects * Calcium value outside of the central laboratory normal reference range * Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases * Urine albumin:creatinine ratio (UACR) \>1800 mg/g (203.4 mg/mmol Cr) * Severe uncontrolled hypertension defined as systolic blood pressure (SBP) \>=180 mmHg and/or diastolic blood pressure (DBP) \>=110 mmHg * Hemoglobin \>=11.0 g/dL (110 g/L) for men; hemoglobin \>=10.0 g/dL (100 g/L) for women * Positive for hepatitis B surface antigen * Positive for anti-hepatitis C virus antibody * History of diabetes insipidus * History of diabetic ketoacidosis or hyperosmolar nonketotic coma * Symptoms of poorly controlled diabetes that would preclude participation in this trial
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 123 locations
International Institute Of Clinical Research
Ozark, United StatesOpen International Institute Of Clinical Research in Google MapsClinical Research Advantage, Inc./Mesa Family Med Ctr, Pc
Tempe, United StatesClinical Research Advantage, Inc.
Tempe, United StatesJohn Muir Physician Network Clinical Research Center
Concord, United States