Phase 3
Completed N=638
Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes
Source: ClinicalTrials.gov NCT00859898 ↗Enrolled (actual)
638
Serious AEs
1.9%
Results posted
Mar 2014
Primary outcomePrimary: Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 (Last Observation Carried Forward) - Randomized Treated Participants — -1.98; -1.45; -1.44 Percent of hemoglobin — p=<0.0001
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 (Last Observation Carried Forward) - Randomized Treated Participants |
-1.98; -1.45; -1.44 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (LOCF) - Randomized, Treated Participants |
-60.4; -46.4; -34.8 | <0.0001 sig |
| SECONDARY Percent Adjusted for Baseline HbA1c of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized, Treated Participants |
46.6; 31.7; 35.5 | 0.0012 sig |
| SECONDARY Adjusted Mean Change From Baseline in HbA1C at Week 24 (LOCF) in Participants Whose Baseline HbA1C Category ≥9.0% |
-2.59; -2.14; -2.05 | 0.0133 sig |
| SECONDARY The Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized, Treated Participants |
-3.33; -2.73; -1.36 | <0.0001 sig |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants |
126; 132; 118; 34; 47; 32 | — |
| SECONDARY Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants |
3; 3; 5; 4; 10; 8 | — |
| SECONDARY Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24 - Treated Participants |
-3.3; -4.0; -1.2; -1.8; -1.9; 0.0 | — |
| SECONDARY Mean Change From Baseline in Seated Heart Rate at Week 24 - Randomized, Treated Participants |
0.6; -0.1; 0.5 | — |
| SECONDARY Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Randomized, Treated Participants |
101; 107; 94; 15; 13; 22 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants |
1; 4; 1; 5; 4; 1 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants |
2; 3; 2; 0; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Treatment naive males and females, >= 18 years old and
= 7.5 and = 1.0 ng/mL (0.34 nmol/L)
- Body Mass Index 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
Data sourced from ClinicalTrials.gov (NCT00859898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.