Effect of DapagliFLOzin on Quality of Life in Patients With Type 2 Diabetes in a Real Clinical PrActice

NCT02719132 | Withdrawn Phase 4

• 1 other identifier: D1690C00043
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, randomised, open-label, crossover, 2-period comparative phase IV study. The primary objective is to compare the effect of dapagliflozin 10 mg once daily in combination with metformin at a daily dose of ≤1,500 mg vs. metformin monotherapy with dose titrated up to 2,500 mg/day on the overall quality of life, obesity-specific quality of life and treatment satisfaction in patients with type 2 diabetes.

Conditions

Diabetes Mellitus Type 2

Keywords

Diabetes Mellitus type 2, dapagliflozin, quality of life

Outcome Measures

Primary Outcomes (1)

• Composite endpoint including quality of life score

  Change in the overall quality of life, obesity-specific quality of life and treatment satisfaction in the course of the therapy by the end of each 24-week treatment period compared to the quality of life, obesity-specific quality of life and treatment satisfaction at baseline.

  48 weeks

Secondary Outcomes (5)

• Change in HbA1c level

  48 weeks

• Change in body weight

  48 weeks

• Change in waist circumference

  48 weeks

• Change in fasting plasma glucose

  48 weeks

• Proportion of patients

  48 weeks

Other Outcomes (4)

• ECG variables

  48 weeks

• number of episodes of hypoglycaemia and ketoacidosis

  48 weeks

• change in glomerular filtration rate

  48 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Arm 1 - therapy with dapagliflozin 10 mg once daily in combination with metformin ≤ 1,500 mg (daily dose) for 24 weeks (Treatment Regimen 1) followed by metformin monotherapy with dose titrated up to 2,500 mg/day for further 24 weeks (Treatment Regimen 2)

Drug: Dapagliflozin; Drug: Metformin

Arm 2

ACTIVE COMPARATOR

Arm 2 - metformin monotherapy with dose titrated up to 2,500 mg/day for 24 weeks (Treatment Regimen 2) followed by therapy with dapagliflozin 10 mg once daily in combination with metformin ≤ 1,500 mg (daily dose) for further 24 weeks (Treatment Regimen 1)

Drug: Dapagliflozin; Drug: Metformin

Interventions

Dapagliflozin DRUG

Dapagliflozin, 10 mg

Also known as: Forxiga

Arm 1; Arm 2

Metformin DRUG

Metformin, up to 2500 mg

Also known as: Glucophage

Arm 1; Arm 2

Eligibility Criteria

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

You may qualify if:

• A voluntary informed consent form for participation in the study signed by the patient prior to any study-specific procedures
• Male and female patients of 18-74 years of age
• Diagnosed type 2 diabetes
• Therapy with metformin at a stable dose ≤1,500 mg/day for at least 8 weeks before enrolment
• HbA1c \>7.0% and ≤10% at the Screening Visit
• C-peptide ≥1.0 ng/ml at the Screening Visit
• Body mass index ≤45.0 kg/m² at the Screening Visit
• For women of childbearing potential - use of reliable birth control methods
• Ability to complete study-specific procedures
• Ability to complete questionnaires

You may not qualify if:

• Type 1 diabetes
• Diabetic ketoacidosis at Screening
• AST and/or ALT \> 3 × upper limit of normal at Screening
• Total serum bilirubin \> 34.19 μmol/l at Screening
• Decompensated diabetes mellitus (HbA1c \>10% at Screening)
• Patients with moderate to severe renal impairment (CrCl \<60 ml/min or \<60 ml/min/1.73 m2 at Screening) or terminal renal insufficiency
• Severe concomitant diseases or severe cardiovascular, renal, hepatic, hematologic, endocrine, mental or rheumatic pathology
• Malignancy within 5 years before enrolment
• Acute (including viral and infectious) diseases within 1 month before the Screening Visit.
• Development of severe acute diseases during the study which significantly affect the benefit/risk ratio for the subject or affecting study efficacy/safety assessment criteria
• History of acute myocardial infarction or stroke within 6 months before the Screening Visit or during the study. Heart failure (NYHA III-IV)
• Treatment with drugs affecting glucose homeostasis (e.g., systemic glucocorticosteroids) within 3 months before to the Screening Visit.
• For women of childbearing potential - a positive pregnancy test or the patient is breast-feeding or planning pregnancy during the study
• History of Hepatitis B and C or HIV
• Individual hypersensitivity to any component of the investigational product (dapagliflozin)

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Marina Shestakova, Professor

  Russian Federal Research Endocrinology center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: March 25, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 20, 2016

Record last verified: 2016-05