Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients with Mild to Moderate Hypertensio

Phase 1

• Conditions: Diabetes mellitus; MedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-002309-36-DE
• Lead Sponsor: SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-06
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

-Male or female patients with Type 2 Diabetes Mellitus (T2DM)
(diagnosed at least 1 year before screening visit), between 18 and 74 years of age, inclusive, with:
-Hypertension grades 1 or 2 as defined by the European Society of Hypertension (ESH)/European Society of Cardiology (ESC) at screening; SBP (systolic blood pressure) has to be in the range of 140-179 mmHg (after 10 minutes resting in supine position, measurement in triplicate with each measurement to be within this range at screening). If the
blood pressure (BP)range is not met at screening, one repeat
measurement at another occasion is allowed prior to inclusion into the study.
-Glycated Haemoglobin A1c (HbA1c) at screening between 6.5% and 11%.
-On a stable treatment with metformin, ie, no change in dose regimen or in dose levels in the last 3 months prior to screening and until randomization.
-On a stable treatment with an ACE inhibitor or an angiotensin receptor blocker after switching from beta-blockers and/or thiazides for eligible patients after screening, ie, no change in dose regimen and in dose levels in the last 4 weeks prior to run-in phase and until randomization
-Body weight between 50.0 kg and 130 kg, inclusive, if male, and
between 40.0 kg and 110 kg, inclusive, if female, body mass index
between 18.0 and 38.0 kg/m2, inclusive.
-Kidney function: Estimated glomerular filtration rate at screening must be 60 mL/min/1.73m2 or higher.
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patients with severe anemia, severe cardiovascular, gastrointestinal,respiratory, neurological, osteomuscular, psychiatric, or active malignant tumor or other major systemic disease or patients with infectious disease, signs of acute illness, or short life expectancy making implementation of the protocol or interpretation of the study results
difficult (as evaluated by detailed medical history and complete physical
and laboratory examination).
-Heart failure New York Heart Association (NYHA) Classification III/IV.
-Any clinically significant abnormality in echocardiography performed at
screening as judged by the investigator based on age, gender and
medical history of the individual patient.
-History of myocardial infarction within the last 12 months prior to
screening.
-Likelihood of requiring treatment during the study period with drugs
not permitted by the study protocol (e.g., long-term systemic
glucocorticoids) and refusing or unable to take alternative treatment.
-Type 1 diabetes mellitus.
-Secondary hypertension of any etiology (eg, renovascular disease,
pheochromocytoma, Cushing's syndrome).
-Clinically significant pulmonary hypertension, in particular World Health
Organisation (WHO) Classes IV (Pulmonary hypertension due to chronic
thrombotic and/or embolic disease [CTEPH]) and V (miscellaneous).
-Diabetic retinopathy.
-History of diabetic ketoacidosis or non-ketotic hyperosmolar coma
within 12 weeks prior to the Screening Visit.
-History of severe hypoglycemia resulting in hospitalization or
unconsciousness/seizures within 6 months prior to the Screening visit.
-History of prior gastric or intestinal surgical procedure including gastric
banding within 3 years before the Screening Visit. Any gastrointestinal
surgery with removal of part of the bowels or the stomach
-History of unexplained pancreatitis, chronic pancreatitis,
stomach/gastric surgery, inflammatory bowel disease.
-Known hypersensitivity to sotagliflozin, empagliflozin or any excipient
of the drug products.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified