The Inova Type 2 Diabetes Mellitus Study (InovaDM2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02222623|
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : August 21, 2014
Last Update Posted : August 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes, Type 2||Drug: Glargine Drug: NPH||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
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.
- Mean daily blood glucose [ Time Frame: 5 days ]
- Percent of total BG readings within target BG 70-180 mg/dL before meals. [ Time Frame: 5 days ]
- Number (Percent) of episodes and total BG readings of hypoglycemic events (BG < 70 mg/dL) [ Time Frame: 5 days ]
- Number (Percent) of total BG readings of severe hyperglycemia (BG > 300 mg/dL) after the first day of treatment. [ Time Frame: 5 days ]
- Hospital mortality [ Time Frame: 5 days ]
- Mean total daily dose of insulin [ Time Frame: 5 days ]
- Length of hospital stay [ Time Frame: within first 30 days of admission ]
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
|United States, Virginia|
|Inova Fairfax Hospital|
|Falls Church, Virginia, United States, 22042|
|Principal Investigator:||Stephen C Clement, MD||Inova Fairfax Hospital|