Effect of SGLT-2 Inhibitor Dapagliflozin on Glycemic Variability in Patients With Diabetes Mellitus Type 2

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will test the hypothesis that early use of combination therapy with dapagliflozin and metformin will provide good glycemic control with low glycemic variability and without hypoglycemic episodes, and will be better tolerated than up-titration of metformin monotherapy. The study will also correlate these benefits with glycated hemoglobin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Research Clinical Centre of the Russian Railways, JSC
• Treatments: Dapagliflozin; Metformin

Criteria

Inclusion criteria

The subject population that will be observed in the study, must fulfil all of the following criteria:

1. Signed informed consent.

2. Written informed consent by women of childbearing age to interception during study participation period, with determination of level of chorionic gonadotropic hormone by the pregnancy test, prior to study enrollment.

3. Age >=18 - 74 years.

4. eGFR >=60 mL/min/1.73 m2 by MDRD formula.

5. BMI <40 kg / m2

6. C-peptide >= 1 ng/ml

7. HbA1c 7 - 9% both included

8. Stabile 1000 mg dose of Metformin daily for at least 8 weeks prior to enrollment

Exclusion criteria

1. The presence of absolute contraindications to therapy by SGLT-2 inhibitor Dapagliflozin:

1.1. Individual idiosyncrasy of any drug component.

1.2. Type 1 diabetes.

1.3. Diabetic ketoacidosis.

1.4. Renal disease, medium to severe (eGFR <60 ml/min /1.73m2 by MDRD formula) or end-stage renal failure.

1.5.Hereditary lactose intolerance, lactase deficiency, and glucose and galactose intolerance.

1.6. Pregnancy and breast-feeding.

1.7. Children under 18 years of age.

1.8. Patients receiving loop diuretics or with reduced volume of blood circulation, such as a result of acute diseases (e.g. gastrointestinal problems).

1.9. Elderly patients aged 75 years and older.

2. A history of moderate or severe congestive heart failure (New York Heart Association [NYHA] Class III or IV) within 3 months prior to the screening visit

3. Increased liver transaminases ALT and/or AST more than 3 times higher than normal.

4. Any condition that in the opinion of the PI confound the evaluation and interpretation of efficacy and or safety data. Significant medical or psychological condition that, in the opinion of the Investigator, would compromise the patient's safety or successful participation in the study.