Type 2 diabetes MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
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Sponsors
University of gothenburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Diabetes mellitus diagnosed according to the WHO criteria and disease characteristics typical for SIDD or SIRD according to the ANDIS clustering • Ongoing metformin therapy with constant dose the last three months • Age 18 years or above • HbA1c =48 and =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • Type 1 diabetes, LADA, MODY, secondary diabetes or history of diabetic ketoacidosis • Anti-diabetic treatment other than metformin within 90 days prior to randomization or changed metformin dose within 90 days prior to randomization • Known acute cardiovascular event, e.g. transient ischemic attack, stroke, acute coronary syndrome, decompensated heart failure, coronary by-pass surgery or other coronary vessel intervention within 90 days prior to screening. • Heart failure NYHA class IV • History of acute or chronic pancreatitis • Known liver cirrhosis • A level of aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT), ALP or bilirubin of more than three times the upper limit of the normal range • Current chronic daily treatment with an oral steroid at a dose equivalent to oral prednisolone =10 mg (e.g., betamethasone =1.2 mg, dexamethasone =1.5 mg, hydrocortisone =40 mg) • Pregnancy or breast-feeding • Known galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. • Estimated glomerular filtration rate <45 ml/min/1,73 m2 or unstable or rapidly progressing renal disease • Participant unable to understand the study information herself or himself • Involvement in the planning and/or conduct of the study • Participation in other clinical trial which may affect the outcome of the present study • Any condition or treatment that in the judgment of the investigator makes it difficult or unsafe to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to study whether the anti-diabetic effect of semaglutide and dapagliflozin, respectively, differs between type 2-diabetic patients with poor insulin secretion (termed "SIDD") and high insulin resistance (termed "SIRD") characteristics. The primary endpoint will be the intraindividual change of HbA1c (DeltaHbA1c) in response to semaglutide or dapagliflozin relative to baseline in SIDD versus SIRD patients. ;Secondary Objective: The secondary endpoints will be the effect of semaglutide and dapagliflozin, respectively, on BMI, waist circumference, patient-reported outcomes, urinary albumin/creatinine index, blood pressure, blood lipids, disposition index, glucose sensitivity, insulin secretory rate, insulin sensitivity index and glucose at 0 and 120 minutes measured from an oral glucose tolerance test in the two patient groups.;Primary end point(s): The primary variable is HbA1c.;Timepoint(s) of evaluation of this end point: After 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary variables include BMI, waist circumference, patient-reported outcomes, urinary albumin/creatinine index, blood pressure, blood lipids, disposition index, glucose sensitivity, insulin secretory rate, insulin sensitivity index and glucose at 0 and 120 minutes measured from the OGTT.;Timepoint(s) of evaluation of this end point: After 24 weeks of treatment | — |
Countries
Sweden
Contacts
Public ContactBirgitta Abrahamsson
University of gothenburg
Outcome results
None listed