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NCT Number: NCT00911625

Glargine Dosing in Hospitalized Patients With Type 2 Diabetes and Renal Insufficiency

It is imperative to devise easy to follow, yet appropriate, guidelines for insulin use in renal-impaired patients. This will be done by comparing two regimens: 1) glargine once daily plus mealtime glulisine based on weight alone and 2) a predetermined dosing reduction algorithm with glargine/glulisine based on weight with reduction for decreased estimated GFR by MDRD as follows: < 30 ml/min/1.73m2 or on dialysis reduce dose by 50% from weight based calculation.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern University Medical Center, Chicago, Illinois, United States

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About this study

This study will enroll 180 hospitalized patients with Type 2 diabetes and moderate to end stage renal insufficiency (estimated glomerular filtration rate is < 30 ml/min/1.73m2 or dialysis) in the Chicagoland area. Participants will be randomized into 1 of 2 protocols after hospital admission. Blood glucose levels will be obtained before meals, at bedtime and whenever necessary for any signs or symptoms of hypoglycemia. The primary endpoint will be the percentage of blood glucose levels reaching goal of 80-180mg/dl. A secondary endpoint will be the percentage of hypoglycemic events, defined as blood glucose values < 60 mg/dl. In addition the percentage of glucose levels within the goal range of 80-180mg.dl will be further separated into excellent control (80-140mg/dl) and acceptable control (141-180mg/dl).

The 2 study groups will be:

  • Glargine & glulisine. The total daily insulin dose will be 0.6 units/kg. Half of this will be given as glargine once daily. The other half will be given as glulisine, divided equally between breakfast, lunch, and dinner with correction factor dosing as needed for elevated premeal hyperglycemia.
  • Glargine & glulisine The calculation for the total daily insulin dose will be 0.3 units/kg. Half of this will be given as glargine in the morning. The other half will be given as glulisine, divided equally between breakfast, lunch, and dinner, with correction factor dosing as needed for elevated premeal hyperglycemia.

All oral agents will be discontinued on admission.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 Diabetes Mellitus of mor than 1year
  • GFR less than 30 ml/min/1.73m2 or dialysis
  • Age greater than 18years
  • Entry blood glucose (fasting or random) greater than 180mg%

Exclusion criteria

  • Type 1 Diabetes Mellitus
  • New onset hyperglycemia
  • Pregnant
  • Solid organ transplant within 1 year
  • Steroids prednisone greater than 7.5mg/day or equivalent
  • Hospital LOS predicted less than 2 days
  • Severe liver disease
  • Known hypopituitarism or adrenal insufficiency
  • Patients in the ICU
  • Patients with hypoglycemic unawareness
  • Outpatient insulin dose less than 0.6 units/kg

Treatment and study plan

0.5 units/kg daily insulin

Drug

Participants randomized to receive this intervention will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.

Other names: Lantus, Apidra

0.25 units/kg daily insulin

Drug

Participants randomized to receive this intervention will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.

Other names: Lantus, Apidra

Primary outcomes

  1. Average Blood Glucose Over 6 Days

    Time frame: 6 Days

    Participants have their blood glucose measured daily for six days. The average blood glucose measure over all six days is compared between the two treatment cohorts.

Secondary outcomes

  1. The Number of Participants Who Experience at Least One Blood Glucose Level Below 70 Milligrams Per Deciliter

    Time frame: 6 Days

    At the end of the study, the number of participants who experience at least one blood glucose level below 70 milligrams per deciliter (mg/dL) is compared between the two treatment cohorts

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Collaborators

  • Sanofi

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 2, 2009
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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