Type 2 Diabetes MellitusPhase 3DERIVENCT02413398

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

A Phase 3 study testing Dapagliflozin 10 mg in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 87 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Dapagliflozin 10 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 321 participants
Where: 87 sitesin 8 countries
Study dates: 15 Jun 2015to 7 Nov 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 9Show fewer

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.

Trial locations and contacts

87 sites in 8 countries.

Country

City, postcode or hospital

87 sites in 8 countries

United States27 sites

Research Site
Brownsburg, Indiana, 46112
Research Site
Burbank, California, 91505
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Chapel Hill, North Carolina, 27517
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Chattanooga, Tennessee, 37404
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Chesterfield, Missouri, 63017
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Chicago, Illinois, 60643
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Chula Vista, California, 91910
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Concord, California, 94520
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Flint, Michigan, 48504
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Fullerton, California, 92835-3404
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Houston, Texas, 77004
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Huntington Beach, California, 92648
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Huntsville, Alabama, 35801
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Jackson, Michigan, 39209
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Kansas City, Missouri, 64111
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Los Gatos, California, 95032
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Louisville, Kentucky, 40213
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Manassas, Virginia, 20110
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Miami, Florida, 33015
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Miami, Florida, 33144
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Miami Springs, Florida, 33166
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Monroe, Louisiana, 71203
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Newport Beach, California, 92663
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Pembroke Pines, Florida, 33027
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Salinas, California, 93901-4446
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San Antonio, Texas, 78215
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San Antonio, Texas, 78224

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Canada17 sites

Research Site
Brampton, Ontario, L6S 0S9
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Cambridge, Ontario, N1R 6V6
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Concord, Ontario, L4K 4M2
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Courtice, Ontario, L1E 3C3
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Etobicoke, Ontario, M9R 4E1
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Greater Sudbury, Ontario, P3E 6C3
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Guelph, Ontario, N1H 1B1
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Halifax, Nova Scotia, B3H 1V7
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London, Ontario, N6G 5A9
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North York, Ontario, M3J 1N2
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Oakville, Ontario, L6M 4H8
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Québec, Quebec, G1V 4G2
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Red Deer, Alberta, T4N 6V7
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Saskatoon, Saskatchewan, S7H 5M3
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Surrey, British Columbia, V3S 2N6
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Toronto, Ontario, M3M 0B2
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Toronto, Ontario, M4G 3E8

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Spain9 sites

Research Site
A Coruña, 15006
Research Site
Alicante, 03010
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Ferrol, 15405
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La Laguna (Tenerife), 38320
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Lleida, 25198
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Madrid, 28007
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Madrid, 28034
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Málaga, 29010
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Pozuelo de Alarcón, 28223

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Bulgaria8 sites

Research Site
Blagoevgrad, 2700
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Botevgrad, 2140
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Kozloduy, 3320
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Kyustendil, 2500
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Sofia, 1233
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Sofia, 1407
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Sofia, 1606
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Stara Zagora, 6000

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Italy8 sites

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Bari, 70124
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Bergamo, 24127
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Chieti Scalo, 66013
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Milan, 20122
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Naples, 80138
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Padova, 35128
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Pisa, 56100
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San Giovanni Rotondo, 71013

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Czechia7 sites

Research Site
Cheb, 350 02
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Hořovice, 268 01
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Krnov, 794 01
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Kutná Hora, 284 30
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Ostrava, 702 00
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Prague, 104 00
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Praha Klanovice, 190 14

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Poland7 sites

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Bielsko-Biala, 43-300
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Bydgoszcz, 85-231
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Lodz, 90-132
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Mrągowo, 11-700
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Ostrowiec Świętokrzyski, 27-400
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Tczew, 83-110
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Wroclaw, 50-403

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Sweden4 sites

Research Site
Gothenburg, 413 45
Research Site
Lund, 221 85
Research Site
Stockholm, 111 57
Research Site
Stockholm, 11324

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About this study

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.

Conditions: Type 2 Diabetes Mellitus
Being tested: Dapagliflozin 10 mg, Matching Placebo for Dapagliflozin
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dapagliflozin 10 mgDrug
Also called Farxiga™
Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy
Matching Placebo for DapagliflozinDrug
Matching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks

Study groups in NCT02413398
Study group	Role	What they receive
Dapagliflozin	Experimental	10 mg Tablets, Oral, Once daily, 24 weeks Receives: Drug: Dapagliflozin 10 mg
Placebo	Placebo comparator	Matching placebo to Dapagliflozin 10 mg tablet. Oral, Once daily, 24 weeks Receives: Drug: Matching Placebo for Dapagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) 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, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" (142 dapaglifozin, 134 placebo) represents the number with change from baseline available at Week 24.
Measured: Baseline, Week 24

Secondary outcomes (3)

Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24.
To compare the mean percent change from baseline in total body weight between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" represents the number with change from baseline available at Week 24.
Measured: Baseline, Week 24
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24.
To compare the mean change from baseline in FPG between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" represents the number with change from baseline available at Week 24.
Measured: Baseline, Week 24
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24.
To compare the mean 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 in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" represents the number with change from baseline available at Week 24.
Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 20157 Nov 2017

First posted9 Apr 2015 (estimated)
Study start15 Jun 2015
Primary completion7 Nov 2017
Study completion7 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 321 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02413398
Sponsor's protocol ID: D1690C00024
Acronym: DERIVE
Status last verified: Sep 2018
First submitted: 7 Apr 2015
Last updated: 31 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PubMed 38770818
Fioretto P, Del Prato S, Buse JB, Goldenberg R, Giorgino F, Reyner D, Langkilde AM, Sjostrom CD, Sartipy P; DERIVE Study Investigators. Efficacy and safety of dapagliflozin in patients with type 2 diabetes and moderate renal impairment (chronic kidney disease stage 3A): The DERIVE Study. Diabetes Obes Metab. 2018 Nov;20(11):2532-2540. doi: 10.1111/dom.13413. Epub 2018 Jul 10.
PubMed 29888547

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT02413398
Acronym / sponsor ID: DERIVE / D1690C00024
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 321 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 15 Jun 2015 (actual)
Primary completion: 7 Nov 2017 (actual)
Study completion: 7 Nov 2017 (actual)
First posted: 9 Apr 2015 (estimated)
Results: Posted 31 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Dapagliflozin	Experimental	Drug: Dapagliflozin 10 mg10 mg Tablets, Oral, Once daily, 24 weeks
Placebo	Placebo comparator	Drug: Matching Placebo for DapagliflozinMatching placebo to Dapagliflozin 10 mg tablet. Oral, Once daily, 24 weeks

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dapagliflozin 10 mgAlso: Farxiga™Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy	Drug	Dapagliflozin
Matching Placebo for DapagliflozinMatching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks	Drug	Placebo

Primary outcome

Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Time frame: Baseline, 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, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" (142 dapaglifozin, 134 placebo) represents the number with change from baseline available at Week 24.

3 secondary outcomes

Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24.
Time frame: Baseline, Week 24
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24.
Time frame: Baseline, Week 24
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24.
Time frame: Baseline, Week 24

Results and safety

Results posted to the registry on 31 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dapagliflozin 10mg QD	160	156
Placebo QD	161	154

Primary outcome: Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24

Time frame: Baseline, Week 24. Mean (Standard Error). Unit: percent

Measure	Dapagliflozin n = 142	Placebo n = 134
Value	-0.37 (0.10)	-0.03 (0.10)

Dapagliflozin vs Placebo: Mean Difference (Final Values): -0.34 (95% CI -0.53 to -0.15), p <0.001, Mixed Models Analysis

Population analysed: For glycaemic measurements (HbA1c and FPG), all measurements after the first dose of rescue medication were excluded. For other non-glycaemic measurements (body weight and SBP), all measurements after the first dose of rescue medication were included.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious AEs were included up to the last day of double-blind treatment + 4 days. SAEs were recorded from the time of Informed Consent through included up to the last day of double-blind treatment + 30 days (or to the end of the 3-week follow-up period, whichever came first).. Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dapagliflozin 10mg QD	9 of 160 (5.6%)	0 of 160 (0%)	0 of 160
Placebo	14 of 161 (8.7%)	0 of 161 (0%)	0 of 161

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38770818Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Derived from this study: PubMed 29888547Fioretto P, Del Prato S, Buse JB, Goldenberg R, Giorgino F, Reyner D, Langkilde AM, Sjostrom CD, Sartipy P; DERIVE Study Investigators. Efficacy and safety of dapagliflozin in patients with type 2 diabetes and moderate renal impairment (chronic kidney disease stage 3A): The DERIVE Study. Diabetes Obes Metab. 2018 Nov;20(11):2532-2540. doi: 10.1111/dom.13413. Epub 2018 Jul 10.
Redacted Study ProtocolLink provided by the sponsor.
Redacted SAPLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

87 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin 10 mg in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 87 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Canada, Spain, Bulgaria, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02413398, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.