Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy

NCT02155374 | Completed Phase 4

• 1 other identifier: NL47135.048.13
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

Objective: to determine which regimen results in best glycemic control and safety profile, expressed as glucose values within target range and occurrence of hypoglycemia. Secondary objective is to compare patient satisfaction, clinical outcomes and toxicity. Study design: Randomized open label cross-over study Study population: Patients ≥ 18 years, who developed glucocorticoid induced hyperglycemia requiring initiation or adjustment of antihyperglycemic agents in a previous chemotherapy cycle. Patient should have ≥2 cycles of chemotherapy scheduled, with 3-10 consecutive days of ≥12,5mg prednisone-equivalent glucocorticoid and a wash-out period of 4-38 days between each cycle. Intervention: subjects will be treated by insulin regimen A and B in random order during two consecutive cycles of chemotherapy. A) intermediate acting insulin 0.01 IU / mg prednisone-equivalent / kg body weight once daily subcutaneous B) Short-acting insulin according to sliding scale regimen, dose adjusted to current grade of hyperglycemia. Main study parameters: Difference in fraction of blood glucose measurements (BGM) within target range and occurrence of hypoglycemia. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both study treatments are just a slight variation in regular care for glucocorticoid induced hyperglycemia. Glycemic control is likely to improve due to treatments and increased counselling. All subjects will receive both treatment regimens. The burden consists of 16-32 extra BGMs over 2 x 4-10 days, wearing the glucose sensor, 1 venipuncture (if HbA1c and creatinin are not determined in routine laboratory within 3 months before start), and 1 randomization visit to the outpatient clinic. Potential risk is the occurrence of hypoglycemia, as is present in any insulin therapy. The investigators account for this risk by giving subjects dietary advice and education how to prevent, recognize and treat hypoglycemia.

Conditions

Hyperglycemia Steroid-induced

Keywords

Glucocorticoid induced hyperglycemia, insulin, chemotherapy

Outcome Measures

Primary Outcomes (1)

• Glycemic control

  Compare achievement of glycemic control in SSI therapy and intermediate acting insulin. Glycemic control is measured as the proportion of blood glucose measurements (BGM) within target range in each subject after 24h of treatment

  24h till end of treatment (expected duration 4-8 days)

Secondary Outcomes (3)

• Patient satisfaction

  At the end of each treatment cycle (expected duration 4-8 days)

• Clinical outcomes

  During each treatment (expected duration 4-8 days)

• Hypoglycemia

  During each treatment (expected duration 4-8 days)

Study Arms (2)

Sliding scale insulin

ACTIVE COMPARATOR

Sliding scale insulin Glucose 7.8-12 mmol/l --\> 2 IU insulin, glucose 12.1-17 mmol/l --\> 4 IU insulin, glucose ≥17.1 mmol/l --\> 6 IU insulin. In case of insufficient control, insulin doses will be increased

Drug: Sliding scale insulin; Behavioral: Dietary advice; Drug: Glucose lowering medication; Drug: Chemotherapy

Intermediate acting insulin

EXPERIMENTAL

Intermediate acting insulin, 0.01 IU / mg prednison / kg body weight with a maximum of 0.5 unit insulin per kg body weight. In case of age \> 70 years or diminished renal function (GFR \<30ml/min)

Drug: Intermediate acting insulin; Behavioral: Dietary advice; Drug: Glucose lowering medication; Drug: Chemotherapy

Interventions

Sliding scale insulin DRUG

Also known as: Short acting insulin on a sliding scale base

Sliding scale insulin

Intermediate acting insulin DRUG

Also known as: NPH insulin, insulatard

Intermediate acting insulin

Dietary advice BEHAVIORAL

Dietary advice to avoid food products with high glycemic index / high glucose load

Intermediate acting insulin; Sliding scale insulin

Glucose lowering medication DRUG

Regular glucose lowering medication as prescribed by the patient's own physician before study entry

Intermediate acting insulin; Sliding scale insulin

Chemotherapy DRUG

Chemotherapy (containing glucocorticoids) as prescribed by the patient's own physician

Also known as: Antineoplastic therapy

Intermediate acting insulin; Sliding scale insulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Written informed consent
• Glucocorticoid induced hyperglycemia in previous cycle of chemotherapy that required therapy initiation or adjustment
• Duration of glucocorticoid cycles 3-10 consecutive days and 4-38 glucocorticoid-free days between 2 cycles
• Prednisone-equivalent dose of ≥ 12,5mg
• At least 2 more cycles of chemotherapy to receive

You may not qualify if:

• History of hypo-unawareness
• Continuous tube or parental feeding
• Continuous (maintenance) systemic glucocorticoid therapy

Sponsors & Collaborators

• Slotervaart Hospital: lead

Study Sites (3)

Slotervaart Hospital

Amsterdam, 1066 EC, Netherlands

Location

Antoni van Leeuwenhoek hospital

Amsterdam, 1066EC, Netherlands

Location

Isala Clinics

Zwolle, 8025 AB, Netherlands

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Insulin, Isophane; Isophane Insulin, Human; Nutrition Assessment; Drug Therapy

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Regular, Human; Insulin; Proinsulin; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: June 4, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 7, 2016

Record last verified: 2016-01

Locations

NL (3)