Effectiveness of Dapagliflozin + Saxagliptin to revert from a standard basalbolusinsulin treatment (BBIT) regimen to a basal supported oral therapy(BOT) in patients with Type 2 Diabetes – a randomised double-blindedstudy – a randomised double-blinded study

Phase 1

• Conditions: Diabetes Melitus Type 2; MedDRA version: 20.0Level: HLGTClassification code 10018424Term: Glucose metabolism disorders (incl diabetes mellitus)System Organ Class: 10014698 - Endocrine disorders; MedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-005740-34-DE
• Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-29
• Study Completion: 2020-03-03
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

•Type 2 diabetes
•Age 18 - 75 years
•Anti-GAD antibodies negative
•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 standard BBIT (basal insulin and at least
once daily bolus insulin) when the bolus insulin dose is not adjusted
to exercise or nutrient intake.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Use of any oral antidiabetic treatment except for metformin (i.e.,
sulphonylureas, DPP-IV inhibitors, thiazolidinediones, SGLT-2
inhibitors) or GLP-1 analogues 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, praecoma diabeticum, 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 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.
•Moderate or severe impaired liver function (serum AST or serum
ALT > 2.5 x ULN, serum total bilirubin = 2.0 mg/dl or serum
albumin = 3.5 g/dl)
•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 > 12g/day for
women and >24g/day for men) within the past 2 years.
•Pregnancy or childbearing potential without adequate
contraception
•Present therapy with systemic steroids
•Known hypersensitivity to Dapagliflozin or Saxagliptin or any of
the components of their formulation or human nasal insulin or any
of the components of its formulation
•Immune suppressive medication and/or immune deficiency
syndromes
•Presence of psychiatric disorder or intake of anti-depressive or
anti-psychotic agents with the exception of benzodiazepines and
SSRIs/SNRI´s
•Potentially unreliable subjects, and those judged by the
investigator to be unsuitable for the study (e.g. subjects needing
assistance for the application of insulin, subjects deemed not to be
compliant with the recommendations given during the study)
•Contraindications for Magnetic resonance (MR) scanning such as
persons with cardiac pacemaker and implants out of metal or
claustrophobia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified