Dapagliflozin + Saxagliptin in a Basal-bolus Insulin Treatment

NCT ID: NCT02965443

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-02
• Study Completion Date: 2020-02-03

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Verum

Dapagliflozin 10 mg + Saxagliptin 5 mg, each once daily, for 24 weeks

Group Type: ACTIVE_COMPARATOR

Dapagliflozin 10 mg + Saxagliptin 5 mg

Intervention Type: DRUG

24 weeks intervention with Dapagliflozin 10 mg + Saxagliptin 5 mg

Placebo

Placebo 1 10 mg + Placebo 2 5 mg, each once daily, for 24 weeks

Group Type: PLACEBO_COMPARATOR

Placebo 1 10 mg + Placebo 2 5 mg

Intervention Type: DRUG

24 weeks intervention with Placebo 1 10 mg + Placebo 2 5 mg

Interventions

Dapagliflozin 10 mg + Saxagliptin 5 mg

24 weeks intervention with Dapagliflozin 10 mg + Saxagliptin 5 mg

Intervention Type: DRUG

Placebo 1 10 mg + Placebo 2 5 mg

24 weeks intervention with Placebo 1 10 mg + Placebo 2 5 mg

Intervention Type: DRUG

Other Intervention Names

Forxiga + Onglyza; Placebo 1 + Placebo 2

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
• 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.
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Tübingen

Tübingen, , Germany

Countries

Germany

Other Identifiers

UTUB - 2015-005740-34

Identifier Type: -

Identifier Source: org_study_id