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

NCT02719756 | Unknown Phase 4

• 1 other identifier: ESR-15-11023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes Mellitus; Hypoglycemic Episodes

Outcome Measures

Primary Outcomes (1)

• Dynamics (delta from the baseline) of blood glucose variability - integral index of glycemia (LBGI-HBGI) after 3 months of therapy

  3 months

Secondary Outcomes (7)

• Dynamics (delta from the baseline or % decrease of blood glucose level) of blood glucose variability (ADRR) after 3 months of therapy

  3 months

• Dynamics of MAGE after 3 months of therapy

  3 months

• Dynamic of glycaemia parameters: % of normoglycemia time after 3 months of therapy

  3 months

• Dynamic of glycaemia parameters: % of hyperglycemia time after 3 months of therapy

  3 months

• Dynamic of glycaemia parameters: % of hypoglycemia time after 3 months of therapy

  3 months

Study Arms (2)

Metformin & Dapagliflozin

EXPERIMENTAL

Metformin stable dose tablets and Dapagliflozin 10 mg tablets by mouths, once daily in morning for 3 months

Drug: Metformin; Drug: Dapagliflozin

Metformin up-titration

ACTIVE COMPARATOR

Metformin tablets up-titration by mouths, for 3 months

Drug: Metformin; Drug: Metformin up-titration

Interventions

Metformin DRUG

Metformin tablets 1000 mg

Also known as: GLUCOPHAGE

Metformin & Dapagliflozin; Metformin up-titration

Dapagliflozin DRUG

Dapagliflozin 10 mg tablets

Also known as: FORXIGA, FARXIGA

Metformin & Dapagliflozin

Metformin up-titration DRUG

Metformin up-titration

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject population that will be observed in the study, must fulfil all of the following criteria:
• Signed informed consent.
• 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.
• Age \>=18 - 74 years.
• eGFR \>=60 mL/min/1.73 m2 by MDRD formula.
• BMI \<40 kg / m2
• C-peptide \>= 1 ng/ml
• HbA1c 7 - 9% both included
• Stabile 1000 mg dose of Metformin daily for at least 8 weeks prior to enrollment

You may not qualify if:

• The presence of absolute contraindications to therapy by SGLT-2 inhibitor Dapagliflozin:
• Individual idiosyncrasy of any drug component.
• Type 1 diabetes.
• Diabetic ketoacidosis.
• Renal disease, medium to severe (eGFR \<60 ml/min /1.73m2 by MDRD formula) or end-stage renal failure.
• Hereditary lactose intolerance, lactase deficiency, and glucose and galactose intolerance.
• Pregnancy and breast-feeding.
• Children under 18 years of age.
• Patients receiving loop diuretics or with reduced volume of blood circulation, such as a result of acute diseases (e.g. gastrointestinal problems).
• Elderly patients aged 75 years and older.
• 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
• Increased liver transaminases ALT and/or AST more than 3 times higher than normal.
• 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.

Sponsors & Collaborators

• Research Clinical Centre of the Russian Railways, JSC: lead

Study Sites (1)

Research Clinical Centre of the Russian Railways, JSC

Moscow, 125993, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Metformin; dapagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Alexander Ametov, prof., MD

  Research Clinical Center of the Russian Railways, JSC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Ametov, prof., MD

CONTACT

(499)1510951; alexander.ametov@gmail.com

Viktoria Blagova, PhD cand.

CONTACT

(499)6130363; vika-blagova@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 25, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 25, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)