Hyperglycemia Steroid-inducedPhase 4GluCon-COPDNCT02253121
Glucose Control During Glucocorticoid Therapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
A Phase 4 study testing Dapagliflozin and Sliding scale insulin in people with Hyperglycemia Steroid-induced, run by Slotervaart Hospital at 4 sites in Netherlands.
Trial summary
Purpose of this study is to treat glucocorticoid induced hyperglycemia due to glucocorticoid pulse therapy in a efficacious, safe and convenient way. Patients with acute exacerbation of COPD treated with glucocorticoid pulse therapy and at high risk for glucocorticoid induced hyperglycemia (defined as known type 2 DM… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia Steroid-induced
- What is being tested?
- Dapagliflozin and Sliding scale insulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 4 sitesNetherlands
- Study dates
- Feb 2015to May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Hospitalization due to AECOPD
- Treatment with ≥30mg prednisone daily or equivalent dose of glucocorticoid for AECOPD
- An expected duration of glucocorticoid treatment of 3-14 days at study entry
- Known type 2 diabetes or glucose ≥ 10 mmol/l at admission
Who cannot join
- High dose glucocorticoid treatment started ≥7 days before study entry
- Need for ICU admission
- Chronic kidney disease stage G3 (glomerular filtration rate <60ml/minute)
- Recurrent genital or urinary tract infection
- Current use of any SGLT-2 inhibiting agent
- Suspected volume depletion
Show all 11Show fewer
- Congestive heart failure functional classification NYHA class IV/IV or instable heart failure
- Acute stroke within 2 months before inclusion.
- Recent cardiovascular event: acute coronary syndrome, hospitalisation for unstable angina or coronary revascularisation within 2 months before inclusion
- Suspected liver disease, confirmed by AST/ALT > 3x ULN or bilirubin >2.0mg/dl (34.2 μmol/l) or serologically proven infection with hepatitis B or hepatitis C
- Pregnancy or breast feeding
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Slotervaart Hospital
Amsterdam, 1066 EC
OLVG West
Amsterdam
Spaarne Ziekenhuis
Hoofddorp
Isala
Zwolle
About this study
Official title: Randomized, Double-blind, Placebo-controlled Trial on the Effectiveness and Safety of Dapagliflozin for Blood Glucose Control During Glucocorticoid Treatment for Acute Exacerbation COPD
Purpose of this study is to treat glucocorticoid induced hyperglycemia due to glucocorticoid pulse therapy in a efficacious, safe and convenient way. Patients with acute exacerbation of COPD treated with glucocorticoid pulse therapy and at high risk for glucocorticoid induced hyperglycemia (defined as known type 2 DM or glucose > 10mmol/l at admission) will be randomized to treatment of dapagliflozin or placebo orally, once daily.
Percentage of time within glucose target range (3,9-10 mmol/l) and incidence rate of hypoglycemia will be compared between dapagliflozin group and placebo group.
Read the detailed description
Rationale: Patients hospitalized for COPD exacerbation treated with high dose glucocorticoids, frequently develop hyperglycaemia. Currently, sliding scale insulin is often used to bridge such episodes. However, sliding scale insulin is patient unfriendly, does not reduce glycaemic excursion nor glycaemic variability. In contrast, pharmacologic inhibition of the sodium glucose transporter-2 (SGLT-2) can be given as an oral agent and is likely to result in better glucose control with lower risk of hypoglycaemia Objective: glucose control and safety (risk of hypoglycaemia). Secondary objectives are patient satisfaction, other safety outcomes and other parameters of glucose control Study design: Double-blind placebo controlled intervention study Study population: Patients hospitalized for an exacerbation of chronic obstructive lung disease who are treated with high dose glucocorticoids.
Intervention: One group receives once daily a 10mg tablet of dapagliflozin and the other group receives once daily a placebo tablet as add on to their prestudy glucose-lowering medication. Both groups will be treated with glucose lowering escape medication if required.
Main study parameters/endpoints: Glucose control is measured as the average time spent within target range in each patient. Safety is measured as the incidence rate of hypoglycaemia during study follow-up.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden of participation consists of the extra capillary glucose measurements that will be done 3-4 times daily and wearing a coin size glucose sensor. Furthermore, patients have to fill out a treatment satisfaction questionnaire. There will be no extra site visits for participants.
Dapagliflozin (experimental group) carries a risk of hypoglycaemia, especially for patient who have concomitant therapy with insulin or sulfonylurea derivatives. Patients will be instructed to anticipate, and if required dosing of glucose lowering therapy will be adjusted. Furthermore, dapagliflozin carries an increased risk of urogenital infections, increased haematocrit and LDL cholesterol.
- Conditions
- Hyperglycemia Steroid-induced
- Being tested
- Dapagliflozin, Sliding scale insulin
- Keywords
- COPD, acute exacerbation, glucocorticoid therapy, hyperglycemia
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Forxiga
Dapagliflozin 10mg during glucocorticoid therapy for acute exacerbation COPD
Sliding scale insulinDrug
Also called Supplemental insulin
Sliding scale insulin with short acting insulin based on current glucose levels
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin + sliding scale insulin. | Experimental | Treatment with dapagliflozin 10mg once daily orally. Treatment will start as soon as possible after initation of glucocorticoid pulse therapy for acute exacerbation COPD and will end when pulse therapy is finished (expected duration 10-14 days). In case of persistent glucose levels > 12 mmol/l, subjects will receive escape treatment with sliding scale insulin. Receives: Drug: Dapagliflozin; Drug: Sliding scale insulin |
| Placebo + sliding scale insulin | Placebo comparator | Treatment with placebo once daily orally. Treatment will start as soon as possible after initation of glucocorticoid pulse therapy for acute exacerbation COPD and will end when pulse therapy is finished (expected duration 10-14 days). In case of persistent glucose levels > 12 mmol/l, subjects will receive escape treatment with sliding scale insulin. Receives: Drug: Sliding scale insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose control
% time within target range (3.9-10 mmol/l)
Measured: 2nd till 7th day of treatment
Risk of hypoglycemia
Incidence rate of hypoglycaemic events
Measured: Randomisation till end of study (expected duration of 12 days)
Secondary outcomes (3)
Patient satisfaction
Diabetes treatment satisfaction questionnaire for inpatients
Measured: During hospital stay (expected average of 9 days)
Clinical outcomes
Duration of hospitalisation, need for treatment escalation, incidence (re-)infections, change in body weight and blood pressure.
Measured: During hospital stay (expected average of 9 days)
Safety
incidence rate of asymptomatic hypoglycaemia, incidence adverse events of special interest (genital infections, urinary tract infections, renal impairment, liver injury and breast-, bladder- and prostate cancer), incidence of other adverse events.
Measured: Randomisation till end of study (expected duration of 12 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completionMar 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperglycemia Steroid-inducedStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Slotervaart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Isala, Spaarne Gasthuis
- Responsible party
- Sponsor
- Investigators
- Victor Gerdes, MD, PhD, Principal investigator, Slotervaart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253121
- Sponsor's protocol ID
- NL49690.048.14
- Other IDs
- 2014-001877-15, 2014
- Acronym
- GluCon-COPD
- Status last verified
- May 2018
- First submitted
- 22 Sep 2014
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Trial on the Effectiveness and Safety of Dapagliflozin for Blood Glucose Control During Glucocorticoid Treatment for Acute Exacerbation COPD
- ClinicalTrials.gov ID
- NCT02253121
- Acronym / sponsor ID
- GluCon-COPD / NL49690.048.14
- Conditions
- Hyperglycemia Steroid-induced
- Keywords
- COPD, acute exacerbation, glucocorticoid therapy, hyperglycemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Slotervaart HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca, Isala, Spaarne Gasthuis
- Study start
- Feb 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of this study is to treat glucocorticoid induced hyperglycemia due to glucocorticoid pulse therapy in a efficacious, safe and convenient way. Patients with acute exacerbation of COPD treated with glucocorticoid pulse therapy and at high risk for glucocorticoid induced hyperglycemia (defined as known type 2 DM or glucose > 10mmol/l at admission) will be randomized to treatment of dapagliflozin or placebo orally, once daily.
Percentage of time within glucose target range (3,9-10 mmol/l) and incidence rate of hypoglycemia will be compared between dapagliflozin group and placebo group.
Detailed description
Rationale: Patients hospitalized for COPD exacerbation treated with high dose glucocorticoids, frequently develop hyperglycaemia. Currently, sliding scale insulin is often used to bridge such episodes. However, sliding scale insulin is patient unfriendly, does not reduce glycaemic excursion nor glycaemic variability. In contrast, pharmacologic inhibition of the sodium glucose transporter-2 (SGLT-2) can be given as an oral agent and is likely to result in better glucose control with lower risk of hypoglycaemia Objective: glucose control and safety (risk of hypoglycaemia). Secondary objectives are patient satisfaction, other safety outcomes and other parameters of glucose control Study design: Double-blind placebo controlled intervention study Study population: Patients hospitalized for an exacerbation of chronic obstructive lung disease who are treated with high dose glucocorticoids.
Intervention: One group receives once daily a 10mg tablet of dapagliflozin and the other group receives once daily a placebo tablet as add on to their prestudy glucose-lowering medication. Both groups will be treated with glucose lowering escape medication if required.
Main study parameters/endpoints: Glucose control is measured as the average time spent within target range in each patient. Safety is measured as the incidence rate of hypoglycaemia during study follow-up.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden of participation consists of the extra capillary glucose measurements that will be done 3-4 times daily and wearing a coin size glucose sensor. Furthermore, patients have to fill out a treatment satisfaction questionnaire. There will be no extra site visits for participants.
Dapagliflozin (experimental group) carries a risk of hypoglycaemia, especially for patient who have concomitant therapy with insulin or sulfonylurea derivatives. Patients will be instructed to anticipate, and if required dosing of glucose lowering therapy will be adjusted. Furthermore, dapagliflozin carries an increased risk of urogenital infections, increased haematocrit and LDL cholesterol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin + sliding scale insulin. | Experimental | Drug: Dapagliflozin, Drug: Sliding scale insulinTreatment with dapagliflozin 10mg once daily orally. Treatment will start as soon as possible after initation of glucocorticoid pulse therapy for acute exacerbation COPD and will end when pulse therapy is finished (expected duration 10-14 days). In case of persistent glucose levels > 12 mmol/l, subjects will receive escape treatment with sliding scale insulin. |
| Placebo + sliding scale insulin | Placebo comparator | Drug: Sliding scale insulinTreatment with placebo once daily orally. Treatment will start as soon as possible after initation of glucocorticoid pulse therapy for acute exacerbation COPD and will end when pulse therapy is finished (expected duration 10-14 days). In case of persistent glucose levels > 12 mmol/l, subjects will receive escape treatment with sliding scale insulin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent
- Hospitalization due to AECOPD
- Treatment with ≥30mg prednisone daily or equivalent dose of glucocorticoid for AECOPD
- An expected duration of glucocorticoid treatment of 3-14 days at study entry
- Known type 2 diabetes or glucose ≥ 10 mmol/l at admission
Key exclusion criteria (11 listed)
- High dose glucocorticoid treatment started ≥7 days before study entry
- Need for ICU admission
- Chronic kidney disease stage G3 (glomerular filtration rate <60ml/minute)
- Recurrent genital or urinary tract infection
- Current use of any SGLT-2 inhibiting agent
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: ForxigaDapagliflozin 10mg during glucocorticoid therapy for acute exacerbation COPD | Drug | Dapagliflozin + sliding scale insulin. |
| Sliding scale insulinAlso: Supplemental insulinSliding scale insulin with short acting insulin based on current glucose levels | Drug | Dapagliflozin + sliding scale insulin., Placebo + sliding scale insulin |
Primary outcome
Glucose control
Time frame: 2nd till 7th day of treatment
% time within target range (3.9-10 mmol/l)
Risk of hypoglycemia
Time frame: Randomisation till end of study (expected duration of 12 days)
Incidence rate of hypoglycaemic events
3 secondary outcomes
Patient satisfaction
Time frame: During hospital stay (expected average of 9 days)
Clinical outcomes
Time frame: During hospital stay (expected average of 9 days)
Safety
Time frame: Randomisation till end of study (expected duration of 12 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Related InfoLink 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.
Victor Gerdes, MD, PhD principal investigator
Slotervaart Hospital
4 sites 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 and Sliding scale insulin in people with Hyperglycemia Steroid-induced, run by Slotervaart Hospital at 4 sites in Netherlands.
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 11 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 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glucose control (time frame: 2nd till 7th day of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2018.