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

NCT02408120 | Completed Phase 4 Results DMC

• 1 other identifier: IRB00078695
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Hyperglycemia; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Mean Daily BG Levels

  Blood glucose (BG) will be measured, and mean daily BG levels will be calculated.

  5 days (average time of discharge from the hospital)

Secondary Outcomes (10)

• Mean Blood Glucose Levels Before Lunch

  5 days (average time of discharge from the hospital)

• Mean Blood Glucose Levels at Bedtime

  5 days (average time of discharge from the hospital)

• Mean Blood Glucose Levels Before Dinner

  5 days (average time of discharge from the hospital)

• Number of Hypoglycemia Events

  5 days (average time of discharge from the hospital)

• Incidence of Hyperglycemia

  5 days (average time of discharge from the hospital)

Study Arms (2)

Insulin Aspart for BG > 140 mg/dL

ACTIVE COMPARATOR

Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>140 mg/dL.

Drug: Insulin glargine; Drug: Insulin aspart; Drug: Supplemental insulin aspart

Insulin Aspart for BG > 260 mg/dL

ACTIVE COMPARATOR

Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>260 mg/dL.

Drug: Insulin glargine; Drug: Insulin aspart; Drug: Supplemental insulin aspart

Interventions

Insulin glargine DRUG

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%.

Also known as: Lantus (glargine)

Insulin Aspart for BG > 140 mg/dL; Insulin Aspart for BG > 260 mg/dL

Insulin aspart DRUG

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%.

Also known as: Novolog

Insulin Aspart for BG > 140 mg/dL; Insulin Aspart for BG > 260 mg/dL

Supplemental insulin aspart DRUG

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

Also known as: Novolog

Insulin Aspart for BG > 140 mg/dL; Insulin Aspart for BG > 260 mg/dL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects admitted to the hospital with acute or chronic medical illnesses or for elective and emergency surgical illness or trauma
• Known history of Type 2 diabetes mellitus for \>3 months
• Treated with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy
• Blood glucose levels between \>140 mg and \<400 mg/dL without laboratory evidence of diabetic ketoacidosis

You may not qualify if:

• Hyperglycemia without a history of diabetes
• Subjects with acute critical illness admitted to the ICU or expected to require ICU admission
• Subjects receiving continuous insulin infusion
• Clinically relevant hepatic disease
• Corticosteroid therapy
• Serum creatinine ≥ 3.5 mg/dL and/or glomerular filtration rate (GFR) \<30
• Subjects unable to sign consent
• Pregnancy

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Vellanki P, Cardona S, Galindo RJ, Urrutia MA, Pasquel FJ, Davis GM, Fayfman M, Migdal A, Peng L, Umpierrez GE. Efficacy and Safety of Intensive Versus Nonintensive Supplemental Insulin With a Basal-Bolus Insulin Regimen in Hospitalized Patients With Type 2 Diabetes: A Randomized Clinical Study. Diabetes Care. 2022 Oct 1;45(10):2217-2223. doi: 10.2337/dc21-1606.

  PMID: 35675498 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Hypoglycemia

Interventions

Insulin Glargine; Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System 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, Short-Acting

Results Point of Contact

• Title: Dr. Priyathama Vellanki
• Organization: Emory University

priyathama.vellanki@emory.edu

404-251-8957

Study Officials

• Priyathama Vellanki, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 3, 2015
• Study Start: October 1, 2015
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: September 28, 2023
• Results First Posted: January 6, 2021

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)