Diabetes, Type 2InovaDM2NCT02222623
The Inova Type 2 Diabetes Mellitus Study
A study testing Glargine and NPH in people with Diabetes, Type 2, run by Inova Health Care Services at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes, Type 2
- What is being tested?
- Glargine and NPH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ages18-75 admitted to a general medicine or surgical Department of Medicine hospitalist services.
- 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).
- 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).
Who cannot join
- Patients with a diagnosis of type 1 diabetes mellitus.
- Patients using nutritional bolus insulin at home.
- Patients with increased blood glucose concentration, but without a known history of diabetes.
- Patients with a history of diabetic ketoacidosis, hyperglycemic hyperosmolar nonketotic syndrome, or ketonuria.
- Patients admitted to or expected to require admission to any intensive care unit (ICU) or intermediate care unit (IMC).
- Patients who are receiving or are anticipated to receive enteral or parenteral nutrition.
Show all 12Show fewer
- Patients admitted for cardiac surgery.
- Patients receiving continuous insulin infusion.
- Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.5 mg/dL).
- Persons with decisional incapacity (mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study).
- Female subjects who are pregnant or immediately (same hospitalization) post partum at time of enrollment into the study.
- Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Fairfax Hospital
Falls Church, Virginia, 22042
About this study
Official title: Insulin Glargine vs NPH as Basal Insulin on Glycemic Values in Hospitalized Patients: The Inova Diabetes Study
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.
Read the 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.
- Conditions
- Diabetes, Type 2
- Being tested
- Glargine, NPH
- Keywords
- insulin, basal, diabetes, hospital, glucose, hypoglycemia, glargine, NPH, neutral protamine hagedorn
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Diabetes Mellitus, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlargineDrug
Also called Lantus
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.
NPHDrug
Also called Novolin N, Humulin N
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.
| Study group | Role | What they receive |
|---|---|---|
| glargine insulin | Active comparator | Basal glargine given once daily in the morning before breakfast plus standard hospital corrective doses of insulin aspart before meals and at bedtime. Receives: Drug: Glargine |
| NPH insulin | Active comparator | Basal NPH given twice daily before breakfast and at bedtime plus standard hospital corrective doses of insulin aspart before meals and at bedtime. Receives: Drug: NPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean daily blood glucose
Measured: 5 days
Secondary outcomes (4)
Percent of total BG readings within target BG 70-180 mg/dL before meals.
Measured: 5 days
Number (Percent) of episodes and total BG readings of hypoglycemic events (BG < 70 mg/dL)
Measured: 5 days
Number (Percent) of total BG readings of severe hyperglycemia (BG > 300 mg/dL) after the first day of treatment.
Measured: 5 days
Hospital mortality
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startApr 2015
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen C Clement, MD, Principal investigator, Inova Fairfax Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222623
- Sponsor's protocol ID
- 14-1623
- Acronym
- InovaDM2
- Status last verified
- Aug 2016
- First submitted
- 19 Aug 2014
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Glargine vs NPH as Basal Insulin on Glycemic Values in Hospitalized Patients: The Inova Diabetes Study
- ClinicalTrials.gov ID
- NCT02222623
- Acronym / sponsor ID
- InovaDM2 / 14-1623
- Conditions
- Diabetes, Type 2
- Keywords
- insulin, basal, diabetes, hospital, glucose, hypoglycemia, glargine, NPH
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 21 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glargine insulin | Active comparator | Drug: GlargineBasal glargine given once daily in the morning before breakfast plus standard hospital corrective doses of insulin aspart before meals and at bedtime. |
| NPH insulin | Active comparator | Drug: NPHBasal NPH given twice daily before breakfast and at bedtime plus standard hospital corrective doses of insulin aspart before meals and at bedtime. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients ages18-75 admitted to a general medicine or surgical Department of Medicine hospitalist services.
- 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).
- 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).
Key exclusion criteria (12 listed)
- Patients with a diagnosis of type 1 diabetes mellitus.
- Patients using nutritional bolus insulin at home.
- Patients with increased blood glucose concentration, but without a known history of diabetes.
- Patients with a history of diabetic ketoacidosis, hyperglycemic hyperosmolar nonketotic syndrome, or ketonuria.
- Patients admitted to or expected to require admission to any intensive care unit (ICU) or intermediate care unit (IMC).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlargineAlso: LantusGlargine 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. | Drug | glargine insulin |
| NPHAlso: Novolin N, Humulin NNPH 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. | Drug | NPH insulin |
Primary outcome
Mean daily blood glucose
Time frame: 5 days
4 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
Related trials for Diabetes, Type 2
RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Not yet recruitingPhase 3
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Diabetes Mellitus, Type 2
Active, not recruiting
Chrono Nutrition and Insulin Resistance in Diabetes
Diabetes Mellitus, Type 2
Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
Not yet recruitingPhase 3
A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, Type 2 Diabetes, and Increased Cardiovascular Risk
Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen C Clement, MD principal investigator
Inova Fairfax Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glargine and NPH in people with Diabetes, Type 2, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean daily blood glucose (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016; AzTrials last refreshed its copy on 3 Nov 2026.