Dapagliflozin Effect on Erythropoiesis and Physical Fitness

NCT03423355 | Withdrawn Phase 4

• 1 other identifier: DapaFIT
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

• Change in blood EPO levels

  The primary objective is to investigate the change in erythropoietin (EPO) levels after 2 weeks of treatment with dapagliflozin in comparison to treatment with placebo.

  2 weeks of treatment

Secondary Outcomes (14)

• Change in physical fitness

  4 weeks of treatment

• Change in reticulocyte concentration, hematocrit and red blood cells

  baseline, 2 weeks and 4 weeks of treatment

• Change in hepcidin

  baseline and 4 weeks of treatment

• Change in blood EPO levels

  baseline, 4 weeks of treatment

• Change in iron status (Fe)

  baseline and 4 weeks of treatment

Study Arms (3)

Dapagliflozin (Forxiga®)

ACTIVE COMPARATOR

Treatment with the SGLT2 inhibitor dapagliflozin 10 mg once daily for 28 days.

Drug: Dapagliflozin (Forxiga®)

Placebo matching Dapagliflozin

PLACEBO COMPARATOR

Treatment with the Dapagliflozin matching placebo once daily for 28 days.

Drug: Placebo matching Dapagliflozin

Hydrochlorothiazide

OTHER

Treatment with the Hydrochlorothiazide 25 mg once daily for 28 days

Drug: Hydrochlorothiazide 25 mg

Interventions

Dapagliflozin (Forxiga®) DRUG

10mg p.o. daily

Dapagliflozin (Forxiga®)

Hydrochlorothiazide 25 mg DRUG

25mg p.o. daily

Hydrochlorothiazide

Placebo matching Dapagliflozin DRUG

Placebo matching Dapagliflozin p.o. daily

Placebo matching Dapagliflozin

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen, Otfried-Mueller Str. 10

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, prospective, randomized, double-blind, controlled, three-armed, parallel group, open-label reference group exploratory study

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: February 6, 2018
• Study Start: September 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 15, 2021

Record last verified: 2021-07

Locations

DE (1)