Diabetes in the Elderly: Prospective Study

NCT01131052 | Completed Phase 4 Results DMC

• 1 other identifier: IRB00038789
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes is highly prevalent in the elderly, afflicting about 20% of older adults aged 65-75 years and 40% of adults \>80years of age. It is expected that the number of elderly people suffering from diabetes will increase in the future, as general life expectancy is increasing. Nursing home residents with diabetes have higher rates of serious comorbidities and have greater activity of daily living dependencies than other residents without diabetes. In addition, persons with diabetes have higher risk of hypertension, heart disease, stroke depression, cognitive impairment, and cardiovascular mortality than individuals without diabetes. There are a few retrospective studies in elderly patients analyzing quality of diabetes care and glycemic control adjusted for medications and presence of co-morbidities in long-term care facilities; however, no previous randomized controlled trials have demonstrated benefits of glycemic control on clinical outcome, quality of life, and rate of acute metabolic complications (hyperglycemia and hypoglycemic events) in long-term care facilities. In addition, it is not known whether the use of basal insulin is superior to treatment with sliding scale insulin (SSI) in long-term care facility residents with type 2 diabetes. Accordingly, the investigators propose to conduct a prospective randomized control trial comparing the efficacy and safety of the basal (glargine) insulin regimen and sliding scale regular insulin in the management of nursing home patients with T2DM.

Conditions

Diabetes; Hyperglycemia

Keywords

elderly populations; diabetes

Outcome Measures

Primary Outcomes (3)

• Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL

  Mean weekly blood glucose concentration less than 70 mg/dL at 3 months

  3 months

• Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL

  Mean weekly blood glucose concentration less than 40 mg/dL at 3 months

  3 months

• Mean of Weekly Fasting Blood Glucose Concentration

  Mean weekly blood glucose concentration at 3 months

  3 months

Secondary Outcomes (5)

• Mean Blood Glucose Concentration

  Baseline

• Mean of Glycosylated Hemoglobin (hbA1c)

  Baseline

• Mean of Daily Blood Glucose Concentration

  Baseline

• Mean of Glycosylated Hemoglobin (hbA1c)

  3 months

• Mean of Glycosylated Hemoglobin (hbA1c)

  6 months

Study Arms (2)

BASAL PLUS

ACTIVE COMPARATOR

Diabetic subjects receive insulin glargine once daily plus corrective doses of insulin glulisine before meals and bedtime as needed

Drug: Insulin Glargine; Drug: Insulin glulisine

sliding scale regular insulin (SSRI)

ACTIVE COMPARATOR

Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed

Drug: Insulin

Interventions

Insulin Glargine DRUG

glargine once a day

Also known as: Lantus

BASAL PLUS

Insulin DRUG

sliding scale regular insulin (SSRI) given before meals and at bedtime as needed

Also known as: Novolin R

sliding scale regular insulin (SSRI)

Insulin glulisine DRUG

glulisine given as needed before meals

Also known as: Apridra

BASAL PLUS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females \> 60 years of age.
• Blood glucose \> 150 mg/dl and A1C \> 7.5%.
• A known history of T2DM, receiving either diet alone, oral monotherapy, or with any combination of oral antidiabetic agents (metformin, sulfonylureas, repaglinide, nateglinide, pioglitazone, rosiglitazone, sitagliptin).
• Patients admitted for non-cardiac elective or emergency surgery or trauma.

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 (26).
• Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.5 mg/dl).
• Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism

Sponsors & Collaborators

• Guillermo Umpierrez: lead

Study Sites (1)

Guillermo Umpierrez

Atlanta, Georgia, 30303, United States

Location

Related Publications (1)

• Pasquel FJ, Powell W, Peng L, Johnson TM, Sadeghi-Yarandi S, Newton C, Smiley D, Toyoshima MT, Aram P, Umpierrez GE. A randomized controlled trial comparing treatment with oral agents and basal insulin in elderly patients with type 2 diabetes in long-term care facilities. BMJ Open Diabetes Res Care. 2015 Aug 28;3(1):e000104. doi: 10.1136/bmjdrc-2015-000104. eCollection 2015.

  PMID: 26336609 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hyperglycemia

Interventions

Insulin Glargine; Insulin; insulin glulisine

Condition Hierarchy (Ancestors)

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; Proinsulin

Results Point of Contact

• Title: Dr. Guillermo Umpierrez
• Organization: Emory University

geumpie@emory.edu

404-778-1665

Study Officials

• Guillermo Umpierrez, MD

  Emory SOM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: May 19, 2010
• First Posted: May 26, 2010
• Study Start: March 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 31, 2014
• Results First Posted: December 31, 2014

Record last verified: 2014-12

Locations

US (1)