Basal Bolus Versus Basal Insulin in Type 2 Diabetes Mellitus (T2DM)

NCT00979628 | Completed Phase 4 Results DMC

• 1 other identifier: IRB00020328a
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 5

Brief Summary

The study is a prospective randomized study comparing safety and effectiveness of a basal-bolus regimen with glargine once daily and glulisine before meals, a basal plus regimen with glargine once daily and supplemental doses of glulisine, and sliding scale regular insulin (SSI) on correction of insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes.

Conditions

Type 2 Diabetes; Hyperglycemia

Keywords

Type 2 Diabetes; Inpatient Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Mean Blood Glucose Levels (Measured in mg/dL) at Randomization Are Compared to Mean Blood Glucose Levels After First Day of Treatment Among Subjects Treated With Basal Plus, Basal -Bolus and SSRI Treatments

  The primary outcome is to determine the effective glycemic control among the subjects that received Basal Plus (glargine once daily plus corrective doses of glulisine before meals and bedtime as needed), Basal Bolus approach of glargine once daily plus corrective doses of glulisine before meals and Sliding Scale Regular Insulin (SSRI). Glycemic control is measured by mean blood glucose(BG) levels in mg/dL after first day of treatment and are compared to mean BG levels at randomization among subjects treated with Basal Plus, Basal -bolus and SSRI treatments. The optimal glycemic control is achieved when BG levels are between 70 mg/dL -140 mg/dL. The BG levels levels below 70 mg/dL are regarded as hypoglycemic events. The BG levels levels above 140 mg/dl are considered elevated and Hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions).

  Randomization and 24 hrs after treatment

Secondary Outcomes (1)

• Number of Patients With Hypoglycemia Events (Blood Glucose Levels < 70 mg/dL) During Their Hospital Stay That Are Treated With Basal Plus, Basal-bolus and SSRI Treatments

  During hospital stay, up to 12 days

Study Arms (3)

Basal Plus Regimen

EXPERIMENTAL

glargine subcutaneously once daily plus corrective doses of glulisine subcutaneously before meals and bedtime as needed

Drug: Basal Plus

Basal Bolus

EXPERIMENTAL

glargine subcutaneously once daily plus glulisine subcutaneously before meals (plus corrective doses of glulisine as needed)

Drug: Basal Bolus

sliding scale regular insulin (SSRI)

ACTIVE COMPARATOR

sliding scale regular insulin subcutaneously four-times daily in patients with T2DM admitted to general medicine and surgery wards.

Drug: sliding scale regular insulin (SSRI)

Interventions

sliding scale regular insulin (SSRI) DRUG

four-time daily in patients with T2DM admitted to general medicine and surgery wards.

Also known as: Novolin R

sliding scale regular insulin (SSRI)

Basal Bolus DRUG

glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)

Also known as: Lantus (insulin glargine), Apidra (insulin glulisine)

Basal Bolus

Basal Plus DRUG

glargine once daily plus corrective doses of glulisine before meals and bedtime as needed

Also known as: Lantus (insulin glargine), Apidra (insulin glulisine)

Basal Plus Regimen

Eligibility Criteria

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

You may qualify if:

• Males or females between the ages of 18 and 75 years admitted to a general medicine or surgical services.
• A known history of type 2 diabetes mellitus \> 3 months, receiving either diet alone, oral monotherapy, or with any combination of oral antidiabetic agents (sulfonylureas, meglitinides, metformin, thiazolidinediones, dipeptidyl peptidase (DPP) IV inhibitors).
• Patients admitted for non-cardiac elective or emergency surgery or trauma.
• Subjects must have an admission BG \> 140 mg and \< 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate \< 18 milliequivalent /L, potential hydrogen (pH) \< 7.30, or positive serum or urinary ketones).

You may not qualify if:

• Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
• Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria \[32\].
• Patients with acute critical or surgical illness admitted to the ICU or expected to require admission to the ICU.
• Patients admitted for coronary artery bypass graft (CABG) or patients receiving continuous insulin infusion.
• Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.0 mg/dl).
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Female subjects are pregnant or breast feeding at time of enrollment into the study.
• Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.
• Female subjects are pregnant or breast feeding at time of enrollment into the study.

Sponsors & Collaborators

• Guillermo Umpierrez, MD: lead
• Sanofi: collaborator
• Medical University of South Carolina: collaborator
• Texas A&M University: collaborator

Study Sites (5)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30030, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-6240, United States

Location

Scott & White Memorial Hospital and Clinic

Temple, Texas, 76508, United States

Location

Related Publications (2)

• Umpierrez GE, Smiley D, Hermayer K, Khan A, Olson DE, Newton C, Jacobs S, Rizzo M, Peng L, Reyes D, Pinzon I, Fereira ME, Hunt V, Gore A, Toyoshima MT, Fonseca VA. Randomized study comparing a Basal-bolus with a basal plus correction insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes: basal plus trial. Diabetes Care. 2013 Aug;36(8):2169-74. doi: 10.2337/dc12-1988. Epub 2013 Feb 22.

  PMID: 23435159 RESULT

• Umpierrez GE, Reyes D, Smiley D, Hermayer K, Khan A, Olson DE, Pasquel F, Jacobs S, Newton C, Peng L, Fonseca V. Hospital discharge algorithm based on admission HbA1c for the management of patients with type 2 diabetes. Diabetes Care. 2014 Nov;37(11):2934-9. doi: 10.2337/dc14-0479. Epub 2014 Aug 28.

  PMID: 25168125 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia

Interventions

Insulin; Insulin Glargine; insulin glulisine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Limitations and Caveats

\- The study excluded patients admitted to the ICU, those with clinically relevant hepatic disease or with serum creatinine \>3.0 mg/dL, patients with severe hyperglycemia, and those receiving a total dose of insulin \>0.4 units/kg/day before admission.

Results Point of Contact

• Title: Guillermo Umpierrez
• Organization: EUSOM

geumpie@emory.edu

4047781665

Study Officials

• Guillermo Umpierrez, MD

  Emory SOM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 18, 2009
• Study Start: January 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 10, 2018
• Results First Posted: April 24, 2014

Record last verified: 2018-09

Locations

US (5)