Type 2 Diabetes mellitus MedDRA version: 17.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Profil Mainz GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diabetes mellitus type 2 2. HbA1c 7.0%–9.9%, both inclusive 3. Treatment with metformin for at least six months (daily dose 1500 – 3000 mg) 4. Age 30–75 years, both inclusive 5. BMI 25–35 kg/m^2, both inclusive 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 21 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Use of any oral antidiabetic treatment except for metformin (i.e., sulphonylureas, DPP-IV inhibitors, thiazolidinediones, SGLT-2 inhibitors) within the last three months prior to Screening 2. Use of insulin or GLP-1 analogues within three months prior to Screening 3. Treatment with any other investigational drug within three months before screening 4. History of diabetes mellitus type 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate alpha- and beta-cell function during combination treatment with dapagliflozin plus saxagliptin compared to dapagliflozin alone in subjects with T2DM on stable metformin background therapy;Secondary Objective: •evaluate the effect of dapagliflozin treatment on alpha- and beta-cell function in subjects with T2DM •evaluate insulin resistance during combination treatment with dapagliflozin plus saxagliptin compared to dapagliflozin alone in subjects with T2DM •evaluate the effect of dapagliflozin treatment on insulin resistance in subjects with T2DM •evaluate body weight during combination treatment with dapagliflozin plus saxagliptin compared to dapagliflozin alone in subjects with T2DM •evaluate the effect of dapagliflozin treatment on body weight in subjects with T2DM •evaluate the risk of hypoglycaemia during combination treatment with dapagliflozin plus saxagliptin compared to dapagliflozin alone in subjects with T2DM •evaluate the effect of dapagliflozin treatment on the risk of hypoglycaemic events in subjects with T2DM ;Primary end point(s): • Glucagon / insulin ratio during hyperglycaemic clamp phase (AUCGluc270–390min / AUCIns270–390min);Timepoint(s) of evaluation of this end point: Endpoint measurements will be performed at baseline (Visit 2) as well as after Treatment Phase 1 (Visit 3) and after Treatment Phase 2 (Visit 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Endpoint measurements will be performed at baseline (Visit 2) as well as after Treatment Phase 1 (Visit 3) and after Treatment Phase 2 (Visit 3);Secondary end point(s): •Glucagon release during hyperglycaemic clamp phase (AUCGluc270–390min; pg/ml*min) •First phase glucagon release during hyperglycaemic clamp phase (AUCGluc270–290min; pg/ml*min) •First phase insulin release during hyperglycaemic clamp phase (AUCIns270–290min; pmol/l*min) •Second phase insulin release during hyperglycaemic clamp phase (AUCIns290–390min; pmol/l*min) •First Phase glucagon / insulin ratio during hyperglycaemic clamp phase (AUCGluc270–290min / AUCIns270–290min) •Second Phase glucagon / insulin ratio during hyperglycaemic clamp phase (AUCGluc290–390min / AUCIns290–390min) •Intact proinsulin release during hyperglycaemic clamp (AUCIP270–390min ; pmol/l*min) •Insulin / proinsulin ratio during hyperglycaemic clamp (AUCIns270–390min / AUCIP270–390min) •C-Peptide release during hyperglycaemic clamp (AUCC-Pep270–390min ; pmol/l*min) •C-Peptide/Insulin ratio during hyperglycaemic clamp (AUCC-Pep270–390min / AUCIP270–390min) •M-Value during euglycaemic-hyperinsulinaemic clamp phase (mg/kg*min) •HOMAIR Index •Body Weight (kg) •Fasting Adiponectin (µg/ml) •Fasting Plasma Glucose (mg/dl) •HbA1C (mmol/mol; %) •QuantoseTM Score •Blood Lipids (Triglycerides [mg/dl]; total, HDL, LDL cholesterol [mg/dl]) •Incidence of treatment-emergent hypoglycaemic episodes from baseline (first administration of trial medication on Visit 2) until end of treatment (last administration of trial medication on Visit 4) •Changes in clinical and laboratory safety variables from baseline until end of treatment •Incidence of adverse events from baseline until end of Treatment | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Thomas Forst
Profil Mainz GmbH & Co KG
Outcome results
None listed