Dapagliflozin + Saxagliptin in a Basal-bolus Insulin Treatment (DapaSaxaBBIT)

University Hospital Tuebingen

Status and phase

Terminated

Phase 4

Conditions

Type 2 Diabetes

Treatments

Drug: Placebo 1 10 mg + Placebo 2 5 mg

Drug: Dapagliflozin 10 mg + Saxagliptin 5 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT02965443

UTUB - 2015-005740-34

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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
Type 1 diabetes
Cardiovascular disease Clinically relevant ventricular tachycardia or ventricular fibrillation, 3rd degree AV block or Torsades de Pointes or treatment with antiarrhythmic drugs. Percutaneous coronary intervention within the past 6 months. Any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery; unstable angina; or stroke.

Uncontrolled unstable angina pectoris or history of pericarditis, myocarditis, endocarditis. Congestive heart failure NYHA (New York Heart Association) class III or IV. Increased risk of thromboembolism, e.g. subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator.

Malignancy including leukemia and lymphoma within the last 5y.
Liver disease such as cirrhosis or chronic active hepatitis.
Significant renal dysfunction (see also exclusion criteria laboratory abnormalities).
State after kidney transplantation
Endocrine disease:

Acromegaly or treatment with growth hormone or similar drugs. Chronic oral or parenteral corticosteroid treatment (>7 consecutive days of treatment) within 8 weeks; thyroid hormone replacement is allowed if the dosage has been stable for at least 3 months and the TSH is within normal limits

•Any of the following significant laboratory abnormalities: eGFR (as calculated by the MDRD equation) < 60 ml/min at Screening Fasting triglycerides >700 mg/dl (>7.9 mmol/l)

Systolic blood pressure outside the range of 100-160 mmHg or diastolic blood pressure above 95 mmHg at Screening
History of active substance abuse (including alcohol > 40g/day) within the past 2 years.
Pregnancy or childbearing potential without adequate contraception
Present therapy with systemic steroids
Presence of psychiatric disorder or intake of anti-depressive or anti-psychotic agents with the exception of benzodiazepines and SSRIs/SNRI´s (selective serotonin reuptake inhibitor)
Potentially unreliable subjects, and those judged by the investigator to be unsuitable for the study.
Contraindications for Magnetic resonance (MR) scanning such as persons with cardiac pacemaker and implants out of metal or claustrophobia