A trial to investigate the efffect of a SGLT-2 inhibitor a DPP-4 inhibitor and a SGLT-2 inhibitor + DPP-4 inhibitor on glucagon levels, endogenous glucose production and lipolysis.
- Conditions
- Diabetes mellitus type 2MedDRA version: 19.0Level: LLTClassification code 10012594Term: DiabetesSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2015-004637-27-AT
- Lead Sponsor
- Medizinische Universität Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 18
•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
;
•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
;
•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
•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.
;
•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.
;
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method