Phase 4
Completed N=183
Phase IV Study With a 36-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Japanese Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin.
Source: ClinicalTrials.gov NCT02157298 ↗Enrolled (actual)
183
Serious AEs
1.6%
Results posted
Mar 2016
Primary outcomePrimary: Adjusted Mean Change in HbA1c Levels — -0.55; 0.05 percentage of hemoglobin glycosylated — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Japanese male and female patients with Type 2 Diabetes and aged ≥ 20 years old, with inadequate glycemic control on insulin defined as Haemoglobin A1c ≥ 7.2% and < 11% will be enrolled into the wash-out phase or directly into the lead-in phase depending on whether the patient has been receiving an Oral antidiabetic drug (including Glucagon-Like Peptide-1 agonists and excluding Thiazolidinedions) other than a Dipeptidyl Peptidase-4 inhibitor as part of the baseline treatment. Additional treatment with a concomitant Dipeptidyl Peptidase-4 inhibitor is allowed. And around 180 eligible patients in total will be randomized into the study with a 2:1 randomization scheme (i.e.120 patients into the dapagliflozin treatment group and 60 patients into the placebo treatment group. All subjects who completed a 16 weeks double-blind treatment period will shift to a 36 weeks open extension treatment period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change in HbA1c Levels |
-0.55; 0.05 | <0.0001 sig |
| SECONDARY Fasting Plasma Glucose |
-21.7; 1.0 | <0.0001 sig |
| SECONDARY Total Body Weight |
-0.6; 0.7 | <0.0001 sig |
| SECONDARY Total Mean Daily Insulin Dose |
-0.74; -0.02 | 0.0743 |
| SECONDARY Proportion of Participants With Mean Daily Insulin Dose Reduction of Greater Than or Equal 10% |
8.2; 4.9 | 0.3727 |
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent prior to any study specific procedures
- Diagnosis of Type 2 Diabetes according the criteria specified by the Japan Diabetes Society
- Japanese Men or women age ≥ 20 years at time of consenting.
- Stable (unless adjustment is required based on Fasting Plasma Glucose values) dose insulin* mono-therapy with the mean insulin [up to two types of insulin within authorized indication in Japan] dose of ≥ 0.2 IU/kg/day AND ≥ 15 IU/body/day over the past 8 weeks prior to enrolment.
- HbA1c ≥ 7.2% and 240 mg/dL (twice in a row) despite the permitted dose adjustment of insulin therapy during washout period and lead-in period.
- Recent cardiovascular events in a patient.
- eGFR 3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN, observed from the central laboratory at Visit 1.
- Total bilirubin >2.0 mg/dL (34.2 μmol/L), observed from the central laboratory at Visit 1.
- Positive serologic evidence of current infectious liver disease including Hepatitis A viral antibody IgM, Hepatitis B surface antigen and Hepatitis C virus antibody, observed from the central laboratory.
- Haemoglobin <10 g/dL (<100 g/L) or 6.2 mmol/L for men; haemoglobin <9.0 g/dL (<90 g/L) or 5.9 mmol/L for women, observed from the central laboratory at Visit 1.
- History of chronic haemolytic anaemia or haemoglobinopathies (for example, sickle cell anaemia, thalassemia, sideroblastic anaemia). Mild haemolysis due to artificial heart valves or due to sickle cell trait is not an exclusion criterion except when haemoglobin levels are too low (as defined in haemoglobin criteria above).
- History of malignancy within the last 5 years prior to enrolment, excluding successful treatment of basal or squamous cell skin cancer.
Data sourced from ClinicalTrials.gov (NCT02157298). 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.