Type 2 Diabetes MellitusPhase 4DERISCNCT02426541

Effects of Dapagliflozin 10 mg on Insulin Resistance in Patients With Type 2 Diabetes Mellitus

A Phase 4 study testing Dapagliflozin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in Finland.

Completed

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

Trial summary

This is an 8-week, single centre, randomized, parallel-group, double-blind, placebo-controlled Phase IV study to evaluate the effect of dapagliflozin on tissue specific insulin sensitivity in patients with Type 2 diabetes mellitus Read more about this study

Who is it for?: Ages 35 to 70 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Dapagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 55 participants
Where: 1 siteFinland
Study dates: 23 Mar 2015to 28 Apr 2016
Phase: Phase 4
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 35 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Main Inclusion Criteria:

Provision of signed informed consent prior to any study specific procedures.
Female or male aged 35 to 70 years inclusive with suitable veins for cannulation or repeated venipuncture
Type 2 Diabetes mellitus defined as HbA1c of ≥ 6.5% and ≤ 10.5%.
Stable (≥ 3 months) T2D treatment with metformin and/or metformin+dipeptidyl peptidase-4 inhibitors (DPP-IV)
Body mass index (BMI) ≤ 40 kg/m2.
Female subjects must be of non-childbearing potential, meeting at least one of the following criteria:
Hysterectomized females
Postmenopausal women, defined as women who have not had a menstrual period within 1 year

Main Exclusion Criteria:

Any condition that is contraindicated with MRI such as, but not limited to, having a pacemaker or claustrophobia.
Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
Recent Cardiovascular Events in a patient:

Acute Coronary Syndrome (ACS) within 2 months prior to enrolment
Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment
Acute Stroke or Transient Ischemic Attack (TIA) within two months prior to enrolment
Less than two months post coronary artery revascularization

Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure.
Blood pressure at enrolment: Systolic BP ≥165 mm Hg and/or diastolic BP ≥100 mm Hg
Any clinically significant illness, medical or surgical procedure or trauma within 4 weeks of the first administration of the investigational product.
On insulin, GLP-1 or other oral antidiabetic drug treatment (metformin or both metformin and DPP-IV allowed) or using other medications known to affect glucose metabolism.
Any clinically significant abnormalities in physical examination, Electrocardiography (ECG) or clinical chemistry results as judged by the investigator. The following specific exclusion criteria apply to the selected Clinical Chemistry results:
Creatinine clearance <60mL/min (estimated with Cockroft-Gault formula).
Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN.
Total bilirubin (TB) >2.0 mg/dL (34.2 µmol/L).
Body weight loss greater than 5% within 3 months prior to Visit 1.
Previous PET scan
History of or presence of (as found at Visit 1) any clinically significant disease, disorder or condition which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.

Trial locations and contacts

1 site in 1 country.

Finland1 site

Research Site
Turku

Other trials in Finland

About this study

Official title: An 8-week, Single Centre, Randomized, Parallel-group, Double-blind, Placebo Controlled Phase IV Study to Evaluate Dapagliflozin 10 mg Once Daily Effects on Insulin Resistance in Subjects With Type 2 Diabetes Mellitus

Conditions: Type 2 Diabetes Mellitus
Being tested: Dapagliflozin, Placebo
Keywords: Diabetes Mellitus, Dapagliflozin, Placebo, Insulin resistance, Insulin sensitivity
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance

What participants receive

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

DapagliflozinDrug
Also called Forxiga, Farxiga
Dapagliflozin 10 mg Tablets, Oral, Once Daily, 8 weeks
PlaceboDrug
Matching placebo to Dapagliflozin 10 mg Tablets, Oral, Once Daily, 8 weeks

Study groups in NCT02426541
Study group	Role	What they receive
Dapagliflozin	Experimental	Dapagliflozin Once Daily 10 mg Receives: Drug: Dapagliflozin
Placebo	Placebo comparator	Matching placebo for Dapagliflozin Once Daily 10 mg Receives: Drug: Placebo

What is being measured

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

Adjusted Change From Baseline in Skeletal Muscle Insulin-stimulated Gluocose Uptake
Adjusted change from baseline in skeletal muscle insulin-stimulated gluocose uptake (umol/min/kg)
Measured: From baseline to Week 8

Secondary outcomes (2)

Adjusted Change in Adipose Tissue Insulin-stimulated Glucose Uptake
Change in adipose tissue insulin-stimulated glucose uptake assessed by hyperglycemic-euglycemic clamp using F-FDG PET
Measured: Baseline to Week 8
Adjusted Change in Liver Insulin-stimulated Glucose Uptake From Baseline to Week 8
Adjusted change in liver insulin-stimulated glucose uptake assessed by hyperglycemic-euglycemic clamp using F-FDG PET
Measured: Baseline to Week 8

Timeline

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

23 Mar 201528 Apr 2016

First posted27 Apr 2015 (estimated)
Study start23 Mar 2015
Primary completion28 Apr 2016
Study completion28 Apr 2016

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 (1)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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02426541
Sponsor's protocol ID: D1690C00025
Other IDs: 2014-005377-36, 2014
Acronym: DERISC
Status last verified: Jul 2017
First submitted: 22 Apr 2015
Last updated: 5 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Latva-Rasku A, Honka MJ, Kullberg J, Mononen N, Lehtimaki T, Saltevo J, Kirjavainen AK, Saunavaara V, Iozzo P, Johansson L, Oscarsson J, Hannukainen JC, Nuutila P. The SGLT2 Inhibitor Dapagliflozin Reduces Liver Fat but Does Not Affect Tissue Insulin Sensitivity: A Randomized, Double-Blind, Placebo-Controlled Study With 8-Week Treatment in Type 2 Diabetes Patients. Diabetes Care. 2019 May;42(5):931-937. doi: 10.2337/dc18-1569. Epub 2019 Mar 18.
PubMed 30885955

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?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An 8-week, Single Centre, Randomized, Parallel-group, Double-blind, Placebo Controlled Phase IV Study to Evaluate Dapagliflozin 10 mg Once Daily Effects on Insulin Resistance in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02426541
Acronym / sponsor ID: DERISC / D1690C00025
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus, Dapagliflozin, Placebo, Insulin resistance, Insulin sensitivity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Antaros Medical, Bioventure Hub, 43183 Mölndal, Sweden
Study start: 23 Mar 2015 (actual)
Primary completion: 28 Apr 2016 (actual)
Study completion: 28 Apr 2016 (actual)
First posted: 27 Apr 2015 (estimated)
Results: Posted 5 Feb 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: DapagliflozinDapagliflozin Once Daily 10 mg
Placebo	Placebo comparator	Drug: PlaceboMatching placebo for Dapagliflozin Once Daily 10 mg

Who may qualify

Ages: 35 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
DapagliflozinAlso: Forxiga, FarxigaDapagliflozin 10 mg Tablets, Oral, Once Daily, 8 weeks	Drug	Dapagliflozin
PlaceboMatching placebo to Dapagliflozin 10 mg Tablets, Oral, Once Daily, 8 weeks	Drug	Placebo

Primary outcome

Adjusted Change From Baseline in Skeletal Muscle Insulin-stimulated Gluocose Uptake
Time frame: From baseline to Week 8
Adjusted change from baseline in skeletal muscle insulin-stimulated gluocose uptake (umol/min/kg)

2 secondary outcomes

Adjusted Change in Adipose Tissue Insulin-stimulated Glucose Uptake
Time frame: Baseline to Week 8
Adjusted Change in Liver Insulin-stimulated Glucose Uptake From Baseline to Week 8
Time frame: Baseline to Week 8

Results and safety

Results posted to the registry on 5 Feb 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 10 MG	16	15
Placebo	16	16

Primary outcome: Adjusted Change From Baseline in Skeletal Muscle Insulin-stimulated Gluocose Uptake

Time frame: From baseline to Week 8. Least squares mean (Standard Error). Unit: umol/min/kg

Measure	Dapagliflozin 10 MG n = 15	Placebo n = 16
Value	0.28 (1.23)	0.28 (1.13)

Dapagliflozin 10 MG vs Placebo: Mean Difference (Final Values): -0.0030 (95% CI -3.07 to 3.07), p = 0.9984, ANCOVA

Population analysed: Full analysis set

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dapagliflozin 10 MG	0 of 16 (0%)	6 of 16 (37.5%)	Not reported
Placebo	0 of 16 (0%)	7 of 16 (43.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30885955Latva-Rasku A, Honka MJ, Kullberg J, Mononen N, Lehtimaki T, Saltevo J, Kirjavainen AK, Saunavaara V, Iozzo P, Johansson L, Oscarsson J, Hannukainen JC, Nuutila P. The SGLT2 Inhibitor Dapagliflozin Reduces Liver Fat but Does Not Affect Tissue Insulin Sensitivity: A Randomized, Double-Blind, Placebo-Controlled Study With 8-Week Treatment in Type 2 Diabetes Patients. Diabetes Care. 2019 May;42(5):931-937. doi: 10.2337/dc18-1569. Epub 2019 Mar 18.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
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Active, not recruiting
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Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
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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.

Pirjo Nuutila, MD, PhD, Professor principal investigator

Turku PET Centre, Turku, Finland

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dapagliflozin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in Finland.

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

Who may be eligible to take part?

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 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 5 Feb 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 Change From Baseline in Skeletal Muscle Insulin-stimulated Gluocose Uptake (time frame: From baseline to Week 8). 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 NCT02426541, which also lists 1 linked publication.

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 5 Feb 2018.