Status:
WITHDRAWN
Dapagliflozin Effect on Erythropoiesis and Physical Fitness
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Eligibility:
All Genders
40-70 years
Phase:
PHASE4
Brief Summary
Dapagliflozin effect on erythropoiesis and physical fitness in patients with type 2 diabetes - a randomized, partly double-blinded, controlled, three armed, parallel group, exploratory study
Detailed Description
Many patients with diabetes present with hyperglycemia, hypertension, hypercholesterolemia and excess weight, which are associated with micro- and macrovascular complications. Therapies to alleviate t...
Eligibility Criteria
Inclusion
- Male or female patients aged between 40 and 70 years (including)
- Diagnosis of type 2 diabetes mellitus (T2DM) with HbA1c between 7.1 10.0% (including)
- Stable treatment of type 2 diabetes, except with SGLT2-Inhibitors over the last 4 weeks
- Body mass index (BMI) between 25 kg/m2 and 35 kg/m2 (including)
- Blood pressure \> 130/80 mmHg but 170/95 mmHg at maximum
- Ability to perform spiroergometry
- Ability to understand and follow study-related instructions
- Negative pregnancy test
- Patients who are receiving the following medications must be on a stable treatment regimen for at least 2 months prior to the screening visit (V0): antihypertensive agents, thyroid replacement therapy, antidepressant agents
Exclusion
- Diagnosis of Type 1 diabetes
- History of diabetic ketoacidosis, hyperosmolar coma or corticosteroid-induced T2DM
- Repeated episodes of severe hypoglycaemia within the last 3 months prior to Screening
- Patients with significant thyroid disease
- Intention to change physical activity within the next 8 weeks
- Clinically significant cardiovascular disease (CVD) or procedure within 3 months prior to enrollment or expected to require coronary revascularization procedure
- Presence of history of severe congestive heart failure (NYHA III and IV), pace maker or aortic stenosis (AS) \> II
- eGFR (as calculated by the MDRD equation) \< 60 ml/min/1.73 m2
- Unstable or rapidly progressing renal disease or anuria
- Concomitant medication with loop diuretics
- Any previous exposure to dapagliflozin or any other SGLT2-Inhibitor, or HCT within last 3 months prior to Screening
- Triglyceride concentrations ≥ 700 mg/dL (≥ 7.98 mmol/L) at the Screening visit (V0)
- History or presence of inflammatory bowel disease or other severe gastrointestinal diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis
- History of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. Current use of gastric balloons is also excluded
- • Significant hepatic disease, including, but not limited to, acute hepatitis, chronic active hepatitis, or severe hepatic insufficiency, including patients with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 3 x upper limit of normal (ULN) and/or total bilirubin (TB) \> 2 mg/dL (\> 34.2 μmol/L) (patients with TB \> 2 mg/dL \[\> 34.2 μmol/L\] and documented Gilbert's syndrome will be allowed to participate)
- Known human immunodeficiency virus (HIV) infection
- History of organ transplantation
- Malignancy (with the exception of basal and squamous cell carcinoma of the skin) within 5 years prior to the Screening visit (V1)
- • Hemoglobinopathy, hemolytic anemia, or chronic anemia (hemoglobin concentration \< 12.0 g/dL) or any other condition known to interfere with the HbA1c methodology
- Patients who have donated blood or had a significant blood loss within 2 months of first dose of study medication or is planning to donate blood during the study
- Patients who have donated plasma within 7 days prior to first dose of study medication
- Systemic corticosteroids within 3 months prior to the Screening visit (V0) known to have a high rate of systemic absorption
- History of chronic obstructive pulmonary disease (COPD) or asthma
- Disabilities contraindicating spiroergometry
- Alcohol consumption \> 20 g/day for women or \> 30 g/day for men
- History of hypersensitivity to any of the study drugs or their ingredients
- Presence of psychiatric disorder or intake of anti-depressive or anti-psychotic agents with the exception of benzodiazepines and SSRIs/SNRI´s
- Addiction or other diseases that preclude the patient from appropriately assessing the nature and scope as well as possible consequences of the clinical study
- Pregnant or breastfeeding women
- Subject (male or female) is not willing to use highly effective contraceptive methods during treatment and for 14 days (male or female) after the end of treatment (highly effective methods are defined as: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence). Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the trial participant and that the vasectomized partner has received medical assessment of the surgical success In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
- Participation in other clinical trials
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03423355
Start Date
September 1 2021
End Date
December 1 2023
Last Update
December 15 2021
Active Locations (1)
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1
University Hospital Tuebingen, Otfried-Mueller Str. 10
Tübingen, Germany, 72076