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Dapagliflozin Effect on Erythropoiesis and Physical Fitness

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ClinicalTrials.gov Identifier: NCT03423355
Recruitment Status : Not yet recruiting
First Posted : February 6, 2018
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
GWT-TUD GmbH

Brief Summary:
Dapagliflozin effect on erythropoiesis and physical fitness in patients with type 2 diabetes - a randomized, double-blind, controlled, parallel group, exploratory study

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus (T2DM) Drug: Dapagliflozin 10mg Drug: Hydrochlorothiazide 25 mg Phase 4

Detailed Description:
A positive outcome of this study could show that by treating diabetes, it is also possible to improve physical fitness, which is a major problem in many patients. Furthermore, all of the participants will receive lifestyle counselling to further improve glycemic control, and blood glucose levels are closely monitored. Thus, patients in all groups will benefit from improvement in glucose levels. Therefore, the benefit-risk balance in this study is considered favorable.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single center, prospective, randomized, double-blind, controlled, parallel group, exploratory study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dapagliflozin Effect on Erythropoiesis and Physical Fitness in Patients With Type 2 Diabetes - a Randomized, Double-blind, Controlled, Parallel Group, Exploratory Study
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dapagliflozin

Treatment with the SGLT2 inhibitor dapagliflozin will be compared to matching placebo and the reference HCT in a parallel design. The study will be performed under double-blinded conditions with respect to treatment with dapagliflozin or matching placebo.

In this study, the effect of dapagliflozin on EPO levels, physical fitness and biomarkers for erythropoiesis and hemodynamic regulation are evaluated and compared to that of matching placebo and the diuretic and anti-hypertensive drug HCT.

Drug: Dapagliflozin 10mg
10mg p.o. daily
Other Name: Dapagliflozin / Placebo

Placebo Comparator: Placebo dapagliflozin

Treatment with the SGLT2 inhibitor dapagliflozin will be compared to matching placebo and the reference HCT in a parallel design. The study will be performed under double-blinded conditions with respect to treatment with dapagliflozin or matching placebo.

In this study, the effect of dapagliflozin on EPO levels, physical fitness and biomarkers for erythropoiesis and hemodynamic regulation are evaluated and compared to that of matching placebo and the diuretic and anti-hypertensive drug HCT.

Drug: Dapagliflozin 10mg
10mg p.o. daily
Other Name: Dapagliflozin / Placebo

Hydrochlorothiazide

Treatment with the SGLT2 inhibitor dapagliflozin will be compared to matching placebo and the reference HCT in a parallel design. However, treatment in the reference group will not be blinded.

In this study, the effect of dapagliflozin on EPO levels, physical fitness and biomarkers for erythropoiesis and hemodynamic regulation are evaluated and compared to that of matching placebo and the diuretic and anti-hypertensive drug HCT.

Drug: Hydrochlorothiazide 25 mg
25mg p.o. daily
Other Name: reference arm




Primary Outcome Measures :
  1. Change in blood EPO levels [ Time Frame: 2 weeks of treatment ]
    The primary objective of this study is to investigate the change of EPO levels in patients with T2DM and hypertension after 2 weeks of treatment with dapagliflozin in comparison to treatment with placebo.


Secondary Outcome Measures :
  1. Change in catecholamine [ Time Frame: baseline, 2 weeks and 4 weeks of treatment ]
    Change in catecholamine and steroid hormone concentrations pmol/L

  2. Change in iron status [ Time Frame: baseline, 2 weeks and 4 weeks of treatment ]
    Change in Iron, transferritin µmol/L



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male or female patients aged between 40 and 70 years (including)

  • Diagnosis of type 2 diabetes mellitus (T2DM) with HbA1c between 7.5-10% (including)
  • Stable treatment with insulin with or without oral antidiabetic drugs (OADs) over the last 4 weeks
  • Body mass index (BMI) between 25 kg/m2 and 35 kg/m2 (including)
  • Blood pressure > 140/85 mmHg
  • Ability to perform at least 75 W in 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 (V1): antihypertensive agents, thyroid replacement therapy, antidepressant agents

Exclusion Criteria:

  • Diagnosis of Type 1 Diabetes
  • History of diabetic ketoacidosis, hyperosmolar coma or corticosteroid-induced T2DM
  • Patients with significant thyroid disease
  • Clinically significant cardiovascular disease (CVD) or procedure within 3 months prior to enrolment 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
  • Creatinine clearance (CrCl) of < 60 ml/min, unstable or rapidly progressing renal disease or anuria
  • Concomitant medication with loop diuretics
  • Triglyceride concentrations ≥ 700 mg/dL (≥ 7.98 mmol/L) at the Screening visit (V1)
  • 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 or suspected 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 or any other condition known to interfere with the HbA1c methodology
  • Has 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
  • Has donated plasma within 7 days prior to first dose of study medication
  • Any previous exposure to dapagliflozin or any other SGLT2 inhibitor, or HCT
  • Systemic corticosteroids within 3 months prior to the Screening visit (V1) known to have a high rate of systemic absorption
  • History of chronic obstructive pulmonary disease (COPD) or asthma
  • Disabilities contraindicating spiroergometry
  • Uncontrolled hypertension with blood pressure > 180/100 mmHg
  • 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
  • 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
  • Women of childbearing potential unless women who meet the following criteria:

    • Post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum follicle-stimulating hormone [FSH] > 40 U/mL)
    • Postoperatively (six weeks after bilateral ovariectomy with or without hysterectomy)
    • Regular and correct use of a contraceptive method with error rate < 1% per year such as implants, depot injections, oral contraceptives or intrauterine devices. As applicable, all methods must be in effect prior to receiving the first dose of study medication and must be practiced during the study and for 10 weeks after the last dose of study medication.
    • Sexual abstinence
    • Vasectomy of the partner

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423355


Contacts
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Contact: Kathrin Kiok, Dr. +49 (0) 35125933 ext 192 kathrin.kiok@gwtonline.de
Contact: Andreas Birkenfeld, Prof. Dr. +49 (0) 351 458 ext 13651 andreas.birkenfeld@uniklinikum-dresden.de

Locations
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Germany
Technical University Dresden University Hospital Carl Gustav Carus Not yet recruiting
Dresden, Germany, 01307
Contact: Andreas Birkenfeld, Prof. Dr.    +49 (0) 351 458 13651 ext 13651    andreas.birkenfeld@uniklinikum-dresden.de   
Sponsors and Collaborators
GWT-TUD GmbH

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Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT03423355     History of Changes
Other Study ID Numbers: DapaFIT
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium-Glucose Transporter 2 Inhibitors
Hypoglycemic Agents