EUCTR2015-004637-27-AT进行中（未招募）1 期
A randomized, double-blind, three arm, three treatment period, cross-over trial to investi-gate the effect 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 during hyper-, normo- and hypoglycaemia in subjects with type 2 diabetes using stable tracer technique.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
相似试验
尚未招募
3 期
To test the efficacy of inspiratory muscle training device Airofit in reducing breathlessness in COPD patientsCTRI/2021/05/033469Airofit AS Copenhagen Denmark
进行中（未招募）
1 期
A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizuresRefractory partial-onset seizures associated with tuberous sclerosis complex (TSC)MedDRA version: 16.0Level: PTClassification code 10045138Term: Tuberous sclerosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-000860-90-GRovartis Pharma Services AG345
已完成
3 期
A three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizurestuberous sclerosis complexseizures1002766410039911NL-OMON39634ovartis Pharma BV16
进行中（未招募）
1 期
A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizuresEUCTR2011-000860-90-ESovartis Farmacéutica, S.A.345
进行中（未招募）
1 期
A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizuresRefractory partial-onset seizures associated with tuberous sclerosis complex (TSC)MedDRA version: 17.0Level: PTClassification code 10045138Term: Tuberous sclerosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-000860-90-BEovartis Pharma Services AG355