Study assessing the glucose-lowering efficacy and safety of luseogliflozin on top of metformin in Caucasian patients with type 2 diabetes mellitus

Phase 3

Completed

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN39549850
• Lead Sponsor: JSC Servier (Russia)

Brief Summary

2023 Results article in https://doi.org/10.1136/bmjdrc-2022-003290 (added 19/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-08-19
• Study Start: 2022-04-14
• Last Update Posted: 4 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 328

Inclusion Criteria

1. Age between 18 and 75 years both inclusive
2. Caucasian race
3. Outpatients with type 2 diabetes mellitus diagnosed for not less than 3 months prior to selection
4. Ongoing monotherapy with metformin =1500 mg daily in the stable dose for at least 3 months
5. Inadequate control of diabetes mellitus as confirmed by HbA1c =7.5% and =10% according to the previous laboratory result not more than 3 months ago
6. BMI less than 36 kg/m²
7. Antihypertensive drugs, beta-blockers, diuretics, drugs for treatment of dyslipidaemia, if administered, should be in a stable dose for at least 6 weeks prior to selection and planned to be continued during the study
8. Signed informed consent before any study investigations. A specific written consent form is to be signed by the patients participating in PK/PD assessment
9. HbA1c 7.5%–10.0% (inclusive) at central laboratory measured in selection period and assessed at inclusion visit
10. The lab results, taken in the selection period, are available and free from any abnormalities likely to interfere with the study conduct or evaluation

Exclusion Criteria

1. Patients who are in an insulin-dependent state (who regularly need to use an insulin preparation)
2. Patients with diabetes mellitus other than type 2 (type 1 diabetes mellitus, diabetes mellitus due to some specific mechanism condition other than type 1 or 2, gestational diabetes mellitus)
3. Unstable diabetes mellitus (documented severe hypoglycemia or hospitalization due to diabetes decompensation or due to hypoglycemia within 1 year prior to selection)
4. Current or previous treatment with 2 or more antidiabetic drugs, except if they were prescribed due to decompensation due to acute illness or surgery and not less than 3 months ago
5. Patient with any uncontrolled endocrine disease other than diabetes mellitus
6. Patients with any of the following renal conditions:
6.1. Known estimated glomerular filtration rate (eGFR) of <45 ml/min/1.73m²
6.2. Stage 3 (overt nephropathy) or worse diabetic nephropathy
6.3. History of nephrectomy or renal transplantation
6.4. History of dialysis within 1 year prior to selection.
7. Patients with an acute or exacerbation of chronic urinary tract infection or of genital infection or patients who have frequent episodes of exacerbation of such infection in the Investigator’s opinion or at least once in 2 months.
8. Patients with an obvious urination disorder due to problems such as neurogenic bladder or prostatic hyperplasia
9. Use of systemic (excluding topical application, intranasal, ophthalmological, intraarticular or inhaled form) glucocorticoids for more than 10 consecutive days within 3 months prior to selection visit
10. Change in dosage of thyroid hormones within 6 weeks prior to selection
11. Treatment with anti-obesity drugs within 3 months prior to selection
12. Recent (i.e. less than 6 months prior to selection) major cardiovascular events (myocardial infarction, cardiac surgery/revascularization, unstable angina, transitory ischemic accident or stroke)
13. Patients with a severe hepatic disorder, pancreatic disorder, hematological disease, gastrointestinal disorder or patients with a history of surgery that may have had a significant effect on absorption.
14. Chronic heart failure NYHA class IV
15. Uncontrolled hypertension: sitting SBP >180 mmHg and/or DBP >100 mmHg at selection visit (exclusion should be based on the mean of two measurements)
16. Patients with a complication of severe diabetic microangiopathy (e.g., preproliferative or proliferative diabetic retinopathy, or diabetic neuropathy whose symptoms cannot be adequately controlled despite continued drug therapy)
17. History of diabetic ketoacidosis or hyperosmolar coma within 3 months prior to selection
18. Any acute disease or exacerbation of chronic diseases 1 month prior to selection
19. Lower extremity complications (such as skin ulcers, bacterial infection, osteomyelitis, and gangrene) at the selection
20. History of lower extremity amputation
21. Patients with malignant tumor with exception of basal cell carcinoma; patients who have been disease free for > 5 years may be included
22. Patients with a mental diso

Study & Design

• Study Type: Interventional
• Study Design: Not specified