Diabetes mellitus type 2 MedDRA version: 19.0 Level: LLT Classification code 10012594 Term: Diabetes System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Forxiga 10 mg
Pharmaceutical Form: Coated tablet
INN or Proposed INN: dapagliflozin
CAS Number: 461432-26-8
Other descriptive name: DAPAGLIFLOZIN
Concentration unit: mg milligram(s)
Concen
Sponsors
Medizinische Universität Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female aged 18-64 years (both inclusive) at the time of signing informed consent. • Subjects diagnosed with type 2 diabetes and on stable treatment for a period of 90 days prior to screening with metformin as monotherapy. Stable is defined as un-changed dose. • Body mass index (BMI) between 20.0 and 35.0 kg/m2 (both inclusive). • HbA1c between 47.5 and 85.8 mmol/mol (6.5 – 10.0%) (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 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range ;Inclusion criteria: • Male or female aged 18-64 years (both inclusive) at the time of signing informed consent. • Subjects diagnosed with type 2 diabetes and on stable treatment for a period of 90 days prior to screening with metformin as monotherapy. Stable is defined as un-changed dose. • Body mass index (BMI) between 20.0 and 35.0 kg/m2 (both inclusive). • HbA1c between 47.5 and 85.8 mmol/mol (6.5 – 10.0%) (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 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range ;Inclusion criteria: • Male or female aged 18-64 years (both inclusive) at the time of signing informed consent. • Subjects diagnosed with type 2 diabetes and on stable treatment for a period of 90 days prior to screening with metformin as monotherapy. Stable is defined as un-changed dose. • Body mass index (BMI) between 20.0 and 35.0 kg/m2 (both inclusive). • HbA1c between 47.5 and 85.8 mmol/mol (6.5 – 10.0%) (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 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Treatment with any glucose lowering agent(s) other than metformin in a period of 90 days before screening. An exception is short-term treatment (= 7 days in total) with insulin due to intercurrent illness. • Clinically significant abnormal haematology, biochemistry, lipids, hormones, coagu-lation and urinalysis. • Acute symptomatic (according to investigator’s judgement) urinary tract infection or genital infection, chronic or recurrent (= 3 annual episodes) cystitis. • Uncontrolled hypertension defined as sitting blood pressure at screening (after resting for 5 min) outside the range of 90-160 mmHg for systolic or 50-100 mmHg for diastolic. • Chronic liver failure with severe liver dysfunction as assessed by the investigator. ;Exclusion criteria: • Treatment with any glucose lowering agent(s) other than metformin in a period of 90 days before screening. An exception is short-term treatment (= 7 days in total) with insulin due to intercurrent illness. • Clinically significant abnormal haematology, biochemistry, lipids, hormones, coagu-lation and urinalysis. • Acute symptomatic (according to investigator’s judgement) urinary tract infection or genital infection, chronic or recurrent (= 3 annual episodes) cystitis. • Uncontrolled hypertension defined as sitting blood pressure at screening (after resting for 5 min) outside the range of 90-160 mmHg for systolic or 50-100 mmHg for diastolic. • Chronic liver failure with severe liver dysfunction as assessed by the investigator. ;Exclusion criteria: • Treatment with any glucose lowering agent(s) other than metformin in a period of 90 days before screening. An exception is short-term treatment (= 7 days in total) with insulin due to intercurrent illness. • Clinically significant abnormal haematology, biochemistry, lipids, hormones, coagu-lation and urinalysis. • Acute symptomatic (according to investigator’s judgement) urinary tract infection or genital infection, chronic or recurrent (= 3 annual episodes) cystitis. • Uncontrolled hypertension defined as sitting blood pressure at screening (after resting for 5 min) outside the range of 90-160 mmHg for systolic or 50-100 mmHg for diastolic. • Chronic liver failure with severe liver dysfunction as assessed by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To compare the effect of treatment with metformin monotherapy (baseline), an add-on SGLT-2 inhibitor, an add-on DPP-4 inhibitor and an add-on combination of a SGLT-2 inhibitor and a DPP-4 inhibitor on endogenous glucose production, peripheral glucose uptake, lipolysis, insulin sensitivity, metabolites, and glucose regulating hormones during normo-, hyper- and hypoglycaemia in a controlled clamp setting under stable metformin therapy.;Primary end point(s): ?Glucagon: Change in glucagon concentration from 5.5 mmol/L low insulin to 11.1 mmol/L: Glucagon11.1-Glucagon. ;Timepoint(s) of evaluation of this end point: At each plateau of the hyper-, normo- and hypoglycaemic clamp;Main Objective: To compare the glucagon response of a treatment with metformin monotherapy (baseline), a SGLT-2 inhibitor, a DPP-4 inhibitor and a combination of a SGLT-2 inhibitor and a DPP-4 inhibitor during normo-, hyper- and hypoglycaemia in a controlled clamp setting under stable metformin therapy.;Secondary Objective: To compare the effect of treatment with metformin monotherapy (baseline), an add-on SGLT-2 inhibitor, an add-on DPP-4 inhibitor and an add-on combination of a SGLT-2 inhibitor and a DPP-4 inhibitor on endogenous glucose production, peripheral glucose uptake, lipolysis, insulin sensitivity, metabolites, and glucose regulating hormones during normo-, hyper- and hypoglycaemia in a controlled clamp setting under stable metformin therapy.;Primary end point(s): ?Glucagon: Change in glucagon concentration from 5.5 mmol/L low insulin to 11.1 mmol/L: Glucagon11.1-Glucagon. ;Timepoint(s) of evaluation of this end point: At each plateau of the hyper-, normo- and hypoglycaemic clamp;Main Objective: To compare the glucagon response of a treatment with metformin monotherapy (baseline), a SGLT-2 inhibitor, a DPP-4 inhibitor and a combination of a SGLT-2 inhibitor and a DPP-4 inhibitor during normo-, hyper- and hypoglycaemia in a controlled clamp setting under stable metform | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): AUCGlucagon: area under the complete glucagon concentration curve during the clamp procedure. GlucagonPG, glucagon concentration at different assessment plateaus (e.g. 11.1 mmol/L) ?Glucagona,b, change in glucagon concentration between different glucose levels (e.g. change from 5.5 mmol/L low insulin to 11.1 mmol/L) EGPplateau, mean endogenous glucose production (EGP) at different assessment plateaus (e.g. assessment plateau 11.1 mmol/L) ?EGPa,b, change in EGP between different assessment plateaus (e.g. change from assessment plateau 5.5 mmol/L low insulin to 11.1 mmol/L) AUCGIR, area under the glucose infusion rate (GIR) curve at different assessment plateaus (e.g. assessment plateau 11.1 mmol/L) ?GIRa,b, change in AUCGIR between different assessment plateaus (e.g. change from assessment plateau 5.5 mmol/L low insulin to 11.1 mmol/L) PGUplateau, mean peripheral glucose uptake (PGU) at different assessment plateaus (e.g. assessment plateau 11.1 mmol/L) ?PGUa,b, change in PGU between different assessment plateaus (e.g. change from assessment plateau 5.5 mmol/L low insulin to 11.1 mmol/L) Lipoplateau, mean lipolysis at different assessment plateaus (e.g. assessment plateau 11.1 mmol/L) ?lipoa,b, change in lipolysis between different assessment plateaus (e.g. change from assessment plateau 5.5 mmol/L low insulin to 11.1 mmol/L) MetabolPG, concentration of lactate, free fatty acids, glycerol and ketone bodies at different assessment plateaus(e.g. 11.1 mmol/L) ?Metabola,b, change in concentration of lactate, free fatty acids, glycerol and ketone bodies between different glucose levels (e.g. change from 5.5 mmol/L low insulin to 11.1 mmol/L) CounterPG, concentration of adrenaline, noradrenaline, growth hormone and cortisol at different assessment plateaus (e.g. 11.1 mmol/L) ?Countera,b, change in concentration of adrenaline, noradrenaline, growth hormone and cortisol between different glucose levels (e.g. change from 5.5 mmol/L low insulin to 11 | — |
Countries
Austria
Contacts
Public ContactStudy Coordinator ;Study Coordinator ;Study Coordinator ;;
Medizinische Universität Graz;Medizinische Universität Graz;Medizinische Universität Graz
Outcome results
None listed