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The Inova Type 2 Diabetes Mellitus Study (InovaDM2)

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ClinicalTrials.gov Identifier: NCT02222623
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : August 21, 2014
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Inova Health Care Services

Brief Summary:
The purpose of this study is to compare the safety and effectiveness of the two different basal insulins commonly used for basal blood sugar control in the treatment of type 2 diabetes mellitus in patients who are hospitalized and require low doses of insulin: neutral protamine Hagedorn (NPH) insulin and glargine (Lantus®) insulin. Previous research has shown that both NPH insulin and glargine (Lantus®) insulin is safe and effective for the control of blood sugar in a type 2 diabetic patient. This research is being done because the costs of medications for diabetic patients are very expensive. Our goal with this research is to show that a less expensive insulin (NPH) is as safe and effective as a more expensive insulin [glargine (Lantus®)] in patients with type 2 diabetes mellitus who are in the hospital.

Condition or disease Intervention/treatment Phase
Diabetes, Type 2 Drug: Glargine Drug: NPH Not Applicable

Detailed Description:
This is a randomized, open label trial comparing effectiveness of insulin glargine and insulin NPH in a basal plus correctional regimen. Patients will be randomized to either an intervention (NPH) or a control group (glargine) upon admission. The following data will be collected: age, sex, weight, preadmission diabetes medications, admission diagnosis, HbA1C, blood glucose (BG), chemistry, hematology, urine analysis, pregnancy test, duration of hospitalization, insulin dose, and discharge status. Data will be recorded and maintained confidentially.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Insulin Glargine vs NPH as Basal Insulin on Glycemic Values in Hospitalized Patients: The Inova Diabetes Study
Study Start Date : April 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: glargine insulin
Basal glargine given once daily in the morning before breakfast plus standard hospital corrective doses of insulin aspart before meals and at bedtime.
Drug: Glargine
Glargine given as 100% total daily dose with breakfast. The initial dose will be calculated using the patient's weight or using their basal insulin doses prior to hospitalization.
Other Name: Lantus

Active Comparator: NPH insulin
Basal NPH given twice daily before breakfast and at bedtime plus standard hospital corrective doses of insulin aspart before meals and at bedtime.
Drug: NPH
NPH 2/3 of the total daily dose given with breakfast, 1/3 of the total daily dose given at bedtime. The initial dose is calculated using the patient's weight or using the basal insulin dose prior to hospitalization.
Other Names:
  • Novolin N
  • Humulin N




Primary Outcome Measures :
  1. Mean daily blood glucose [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Percent of total BG readings within target BG 70-180 mg/dL before meals. [ Time Frame: 5 days ]
  2. Number (Percent) of episodes and total BG readings of hypoglycemic events (BG < 70 mg/dL) [ Time Frame: 5 days ]
  3. Number (Percent) of total BG readings of severe hyperglycemia (BG > 300 mg/dL) after the first day of treatment. [ Time Frame: 5 days ]
  4. Hospital mortality [ Time Frame: 5 days ]

Other Outcome Measures:
  1. Mean total daily dose of insulin [ Time Frame: 5 days ]
  2. Length of hospital stay [ Time Frame: within first 30 days of admission ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients ages18-75 admitted to a general medicine or surgical Department of Medicine hospitalist services.
  2. A known history of T2DM, receiving either diet alone, low dose insulin (≤0.4 units/kg/day), OADs, GLP1 analogs, or in any combination of OADs, GLP1 analogs and low dose insulin (≤0.4 units/kg/day).
  3. Subjects must have a BG >140 mg/dL and ≤240 mg/dL before randomization without laboratory evidence of diabetic ketoacidosis or hyperglycemic hyperosmolar nonketotic syndrome (bicarbonate <18 mEq/L, pH <7.30, or positive serum or urinary ketones, BG >240 mg/dL).

Exclusion Criteria:

  1. Patients with a diagnosis of type 1 diabetes mellitus.
  2. Patients using nutritional bolus insulin at home.
  3. Patients with increased blood glucose concentration, but without a known history of diabetes.
  4. Patients with a history of diabetic ketoacidosis, hyperglycemic hyperosmolar nonketotic syndrome, or ketonuria.
  5. Patients admitted to or expected to require admission to any intensive care unit (ICU) or intermediate care unit (IMC).
  6. Patients who are receiving or are anticipated to receive enteral or parenteral nutrition.
  7. Patients admitted for cardiac surgery.
  8. Patients receiving continuous insulin infusion.
  9. Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.5 mg/dL).
  10. Persons with decisional incapacity (mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study).
  11. Female subjects who are pregnant or immediately (same hospitalization) post partum at time of enrollment into the study.
  12. Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222623


Locations
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United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Inova Health Care Services
Investigators
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Principal Investigator: Stephen C Clement, MD Inova Fairfax Hospital

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Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT02222623     History of Changes
Other Study ID Numbers: 14-1623
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016

Keywords provided by Inova Health Care Services:
insulin
basal
diabetes
hospital
glucose
hypoglycemia
glargine
NPH
neutral protamine hagedorn

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs