Effectiveness of Dapagliflozin + Saxagliptin to Revert From a Basal-bolus Insulin Treatment (BBIT) Regimen to a Basal Supported Oral Therapy (BOT) in Patients With Type 2 Diabetes
Overview
- Phase
- Phase 4
- Intervention
- Dapagliflozin 10 mg + Saxagliptin 5 mg
- Conditions
- Type 2 Diabetes
- Sponsor
- University Hospital Tuebingen
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Percentage of subjects achieving a HbA1c ≤ 7.5% and having a reversal from a BBIT to a BOT regimen
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
To perform a study that investigates the effectiveness of adding the SGLT2 inhibitor dapagliflozin + the dipeptidyl peptidase 4 (DPP-4) inhibitor saxagliptin vs placebo to revert from a BBIT regimen to a BOT regimen in patients with type 2 diabetes.
Detailed Description
This will be a phase IV study investigating the efficacy and safety of adding the SGLT2 inhibitor dapagliflozin together wih the DPP-4 inhibitor saxagliptin to an intensified insulin treatment regimen. Because BOT is superior to BBIT in respect to the development of bodyweight, hypoglycaemia and patient satisfaction in type 2 diabetes, we hypothesize that the combined addition of the SGLT2 inhibitor dapagliflozin with the DPP-4 inhibitor saxagliptin is effective and safe to revert from a BBIT to a BOT treatment regimen.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 2 diabetes
- •Age 18 - 75 years
- •Anti-GAD antibodies negative (Glutamic Acid Decarboxylase)
- •C-peptide levels ≥ 1.5 ng/mL
- •Fasting blood glucose \> 126 mg/dl
- •HbA1c 8.0 - 10.5 %
- •BMI 25.0 - 45.0 kg/m2
- •Previous therapy with BBIT (basal insulin and at least once daily bolus insulin)
Exclusion Criteria
- •Use of any oral antidiabetic treatment except for metformin (i.e., sulphonylureas, DPP-IV inhibitors, thiazolidinediones, SGLT-2 inhibitors (Sodium dependent glucose transporter) or GLP-1 analogues (glucagone like peptide) within the last three months prior to Screening
- •Repeated episodes of severe hypoglycaemia within the last six months prior to Screening
- •History of diabetic ketoacidosis, precoma diabetica, or diabetic coma
- •Treatment with any other investigational drug within the last three months before Screening
- •Acute infections within the last four weeks prior to Screening
- •Recurrent urogenital infections
- •History of pancreatitis
- •Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- •History of severe or multiple allergies
- •Concomitant participation in other clinical trials
Arms & Interventions
Verum
Dapagliflozin 10 mg + Saxagliptin 5 mg, each once daily, for 24 weeks
Intervention: Dapagliflozin 10 mg + Saxagliptin 5 mg
Placebo
Placebo 1 10 mg + Placebo 2 5 mg, each once daily, for 24 weeks
Intervention: Placebo 1 10 mg + Placebo 2 5 mg
Outcomes
Primary Outcomes
Percentage of subjects achieving a HbA1c ≤ 7.5% and having a reversal from a BBIT to a BOT regimen
Time Frame: 24 weeks
Percentage of subjects achieving a HbA1c ≤ 7.5% and having a reversal from a BBIT to a BOT regimen with treatment of dapagliflozin/saxagliptin or placebo
Secondary Outcomes
- changes in daily insulin dose between groups(24 weeks)
- changes in microalbuminuria between groups(24 weeks)
- changes in well being and disease perception between groups(24 weeks)
- changes in fear of hypoglycemia between groups(24 weeks)
- changes in fasting blood glucose between groups(24 weeks)
- changes in body fat content between groups(24 weeks)
- changes in HbA1c between groups(24 weeks)
- changes in hypoglycaemic events between groups(24 weeks)
- changes in bodyweight between groups(24 weeks)
- changes in liver fat content between groups(24 weeks)
- changes in intra-nasal insulin-induced brain fMR (functional magnetic resonance) imaging results between groups(24 weeks)
- changes in the blood lipid profile between groups(24 weeks)
- changes in body fat distribution between groups(24 weeks)
- changes in blood pressure between groups(24 weeks)