Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes

Summary

The purpose of this study is to test whether using extra doses of aspart insulin to correct blood sugars before meals improves the care of patients with type 2 diabetes in the hospital who are already receiving the standard of care treatment with glargine and aspart insulin injections to control blood sugar levels. Studies done in the past indicate that blood sugar levels are controlled on the standard treatment of insulin and that most patients do not need the small extra dose of insulin at bedtime. The investigators want to test if there is any benefit to giving patients extra doses of insulin during the day to correct the high blood sugars.

Conditions

• Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin glargine

Half of total daily dose (TDD) will be given as insulin glargine and will be given once daily, at the same time of the day. Daily insulin dose will be adjusted as follow: * If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change * If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day * If the fasting and pre-dinner BG is \>180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day * If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day * If a patient develops hypoglycemia (BG \<70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%.

DRUG

Insulin aspart

Half of total daily dose will be given as insulin aspart and in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, the dose of aspart will be held. Daily insulin dose will be adjusted as follow: * If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change * If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day * If the fasting and pre-dinner BG is \>180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day * If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day * If a patient develops hypoglycemia (BG \<70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%.

DRUG

Supplemental insulin aspart

Insulin aspart will be administered following the supplemental insulin scale protocol. For the arm receiving supplemental insulin aspart at BG levels greater than 140 mg/dL, then supplemental insulin scale is as follows: * BG \>141-180 mg/dL; 2-4 units of insulin aspart * BG between 181-220 mg/dL; 3-6 units of insulin aspart * BG between 221-260 mg/dL; 4-8 units of insulin aspart * BG between 261-300 mg/dL; 5-10 units of insulin aspart * BG between 301-350 mg/dL; 6-12 units of insulin aspart * BG between 351-400 mg/dL; 7-14 units of insulin aspart * BG \> 400 mg/dL; 8-16 units of insulin aspart For the arm receiving supplemental insulin aspart at BG levels greater than 260 mg/dL, then supplemental insulin scale is as follows: * BG between 261-300 mg/dL; 5-10 units of insulin aspart * BG between 301-350 mg/dL; 6-12 units of insulin aspart * BG between 351-400 mg/dL; 7-14 units of insulin aspart * BG \> 400 mg/dL; 8-16 units of insulin aspart

Sponsors & Collaborators

• Emory University

  lead OTHER

Principal Investigators

• Priyathama Vellanki, MD · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-31

Primary Completion

2019-12-11

Completion

2019-12-11

Countries

• United States

Study Locations