A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes - Full Text View

Purpose

The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal impairment.This study will be conducted at approximately 100 centres from countries across North America and European regions. It is planned to randomize a total of 302 patients.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Dapagliflozin 10 mg Drug: Matching Placebo for Dapagliflozin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator Primary Purpose: Treatment
Official Title:	A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase III Study to Evaluate the Glycemic Efficacy and Renal Safety of Dapagliflozin in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment (CKD 3A) Who Have Inadequate Glycemic Control.

Resource links provided by NLM:

Drug Information available for: Dapagliflozin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change from baseline in HbA1c at Week 24 [ Time Frame: At Week 24 ]
To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes and CKD stage 3A.

Secondary Outcome Measures:

Percent change from baseline in total body weight at Week 24. [ Time Frame: At Week 24 ]
To compare the percent change from baseline in total body weight between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment.
Change from baseline in FPG at Week 24. [ Time Frame: At Week 24 ]
To compare the change from baseline in FPG between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment.
Change from baseline in seated SBP at Week 24. [ Time Frame: At Week 24 ]
To compare the change from baseline in seated systolic blood pressure (SBP) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment.


Enrollment:	321
Actual Study Start Date:	June 15, 2015
Estimated Study Completion Date:	November 8, 2017
Estimated Primary Completion Date:	November 8, 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dapagliflozin 10 mg Tablets, Oral, Once daily, 24 weeks	Drug: Dapagliflozin 10 mg Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy Other Name: Farxiga™
Placebo Comparator: Placebo Matching placebo to Dapagliflozin 10 mg tablet. Oral, Once daily, 24 weeks	Drug: Matching Placebo for Dapagliflozin Matching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks

Eligibility


Ages Eligible for Study:	18 Years to 74 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female or male aged ≥18 years and <75 years.
History of T2DM for more than 12 months.
Inadequate glycemic control, defined as HbA1c ≥7.0% and ≤11%
Stable anti-diabetic treatment regimen
Renal impairment: CKD 3A

Exclusion Criteria:

Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
Severe uncontrolled hypertension defined as SBP ≥180 mmHg and/or Diastolic Blood Pressure (DBP) ≥110 mmHg
Any of the following Cardiovascular (CV)/Vascular Diseases within 3 months of prior to signing the consent at visit 1:

Myocardial infarction, Cardiac surgery or revascularization(CABG/PTCA), Unstable angina, Unstable heart failure (HF), HF New York Heart Association (NYHA) Class IV,Transient ischemic attack (TIA) or significant cerebrovascular disease, Unstable or previously undiagnosed arrhythmia.

History of any biopsy or imaging verifying intercurrent kidney disease (such as glomerular nephritis or sign of renal artery stenosis) other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis.
Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency.
Ongoing treatment with any SGLT2-inhibitor, GLP-1 analogue, or rapid/short acting insulins at screening.
Participation in another clinical study with an Investigational Product (IP) during the last 30 days prior to signing the consent at visit 1.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02413398

Show 87 Study Locations

Sponsors and Collaborators

AstraZeneca

More Information


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT02413398 History of Changes
Other Study ID Numbers:	D1690C00024
Study First Received:	April 7, 2015
Last Updated:	July 13, 2017

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases

ClinicalTrials.gov processed this record on July 14, 2017

A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes (DERIVE)