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

NCT02719756 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-03-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Metformin

Metformin tablets 1000 mg

DRUG

Dapagliflozin

Dapagliflozin 10 mg tablets

DRUG

Metformin up-titration

Sponsors & Collaborators

  • Research Clinical Centre of the Russian Railways, JSC

    lead OTHER

Principal Investigators

  • Alexander Ametov, prof., MD · Research Clinical Center of the Russian Railways, JSC

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-10-31
Completion
2016-12-31

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02719756 on ClinicalTrials.gov