Randomized, double-blind, placebo-controlled trial on the effectiveness and safety of dapagliflozin for blood glucose control during glucocorticoid treatment for acute exacerbation COPD

Randomized, double-blind, placebo-controlled trial on the effectiveness and safety of dapagliflozin for blood glucose control during glucocorticoid treatment for acute exacerbation COPD - GluCon-COPD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41812

Enrollment

Registered

2014-08-21

Start date

2015-02-16

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucocorticoid induced hyperglycemia high blood glucose due to glucocorticoid therapy

Interventions

Dapagliflozin 10mg or placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >= 18 years and =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

Exclusion criteria

Exclusion criteria: - Glucocorticoid pulse therapy started >=7 days before study entry - Need for ICU admission - Chronic kidney disease stage G3 (glomerular filtration rate

Design outcomes

Primary

Measure	Time frame
Effectiveness: The difference in mean percentage time spent within glucose target range on 2nd till 7th day of treatment, between the dapagliflozin group and the control group as measured by subcutaneous continuous glucose monitor. Target range is defined as random glucose 4-10 mmol/l according to ADA guidelines for non-critically ill inpatients (20). Safety: Incidence rate of hypoglycaemic events per patient-day. A hypoglycaemic event is defined according to Whipple*s criteria (i.e. symptoms known or likely to be caused by hypoglycaemia, interstitial glucose 3.9 mmol/l, relief of symptoms when glucose is raised to normal).	—

Measure

Time frame

Effectiveness: The difference in mean percentage time spent within glucose target range on 2nd till 7th day of treatment, between the dapagliflozin group and the control group as measured by subcutaneous continuous glucose monitor. Target range is defined as random glucose 4-10 mmol/l according to ADA guidelines for non-critically ill inpatients (20). Safety: Incidence rate of hypoglycaemic events per patient-day. A hypoglycaemic event is defined according to Whipple*s criteria (i.e. symptoms known or likely to be caused by hypoglycaemia, interstitial glucose 3.9 mmol/l, relief of symptoms when glucose is raised to normal).

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Secondary

Measure	Time frame
1. Patient satisfaction measured by Diabetes Treatment Satisfaction Questionnaire for inpatients (DTSP-IP) (21) specifically directed at glucose lowering treatment. 2. Clinical outcomes: duration of hospitalisation, need for intensification of treatment for AECOPD, change in body weight and blood pressure during investigational treatment. 3. Other parameters of glucose control: - Glucose variability by mean amplitude of glycaemic excursion (MAGE) - Total daily dose of insulin - Mean daily glucose concentration - Mean percentage time spent within glucose target range from start till end of treatment 4. Safety: incidence rate of asymptomatic hypoglycaemia, incidence of genital infections and urinary tract infections, incidence of other adverse events.	—

Measure

Time frame

1. Patient satisfaction measured by Diabetes Treatment Satisfaction Questionnaire for inpatients (DTSP-IP) (21) specifically directed at glucose lowering treatment. 2. Clinical outcomes: duration of hospitalisation, need for intensification of treatment for AECOPD, change in body weight and blood pressure during investigational treatment. 3. Other parameters of glucose control: - Glucose variability by mean amplitude of glycaemic excursion (MAGE) - Total daily dose of insulin - Mean daily glucose concentration - Mean percentage time spent within glucose target range from start till end of treatment 4. Safety: incidence rate of asymptomatic hypoglycaemia, incidence of genital infections and urinary tract infections, incidence of other adverse events.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)