Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
Participants are randomized using Interactive Web Response System (IWRS) block randomization with stratification based on the baseline HbA1c level to four parallel groups with 1:1:1:1 distribution: 2.
Sponsors
JSC Servier (Russia)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of HbA1c measured using the validated method at the central laboratory between week 0 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fasting plasma glucose level measured using the validated method at the central laboratory at each study visit (selection, inclusion, Week 4, Week 8, Week 12 and End-of-Study visits) 2. Post-prandial plasma glucose level measured using the validated method at the central laboratory 2 hours after the start of the standardized meal at baseline (week 0) and the end of the double-blind treatment (week 12). A standardized meal (breakfast) containing about 600 kcal was provided. 3. Body weight measured using the calibrated scale at each study visit (selection, inclusion, week 4, week 8, week 12 and end-of-study visit) 4. Waist circumference measured at midway between the lowest ribs and the iliac crest in the standing position at the end of normal expiration with the tape in the horizontal plane, at each study visit (selection, inclusion, week 4, week 8, week 12 and end-of-study visit) Safety measurements performed throughout the study: 5. Physical examination documented in the source documents at each study visit (selection, inclusion, week 4, week 8, week 12 and end-of-study visit) 6. Vital signs (heart rate, systolic and diastolic blood pressure) at each study visit (selection, inclusion, week 4, week 8, week 12 and end-of-study visit) measured at the same arm after at least 5 min rest in the sitting position using two measurements taken with at least 2-minute intervals 7. A standard 12-lead ECG performed after 10 min at rest in a supine position and interpreted by a qualified physician at the selection visit and week 12 8. Laboratory parameters measured by a central laboratory using the validated methods: 8.1. Haematology and biochemistry at selection and week 12 visits 8.2. Abridged biochemistry at week 4 and week 8 visits 8.3. Urinalysis at all study visits 8.4. Ketones ana | — |
Countries
Russian Federation
Contacts
Public ContactElena Isachenko
Outcome results
None listed