- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02424500
Multi-Center Study Comparing Efficacy and Safety of Frequently Modified Insulin Therapy
Prospective, Open-Label, Randomized, Controlled, Multi-Center Study Comparing Efficacy and Safety of Frequently Modified Insulin Therapy Using Dosage Recommending Device
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to demonstrate that the use of d-Nav (d-Nav group) is superior to titration of insulin dosage relying on data from glucose meters with health care provider support (Control) in the management of insulin treated diabetes, by randomizing 200 insulin treated subjects with type 2 diabetes.
Primary Objective: To demonstrate a greater reduction in HbA1c at 6-months for d-Nav users compared to control patients in the primary cohort.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55416-2699
- Park Nicollet Institute / International Diabetes Center, Minneapolis, MN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 21 to 70 years of age
- If female, must be of non-childbearing potential or have a negative urine pregnancy test at screening and using adequate method of contraception throughout conduct of the study
- Clinical diagnosis of Type-2 diabetes for at least 1-year
- HbA1c 7.5% to 11% inclusive
Total daily dose of insulin of 25 units or more (10 units if on Lantus® alone) using one of these insulin regimens:
- Regimen 1 - a single injection of the long-acting insulin analog Lantus® (Glargine) per day (limited to a daily dose that is no more than 0.7 units per kg of body weight);
- Regimen 2 - twice daily biphasic insulin (i.e., Humalog® Mix 75/25, NovoLog® Mix 70/30) or pre-mixed insulin (i.e., Humulin® 70/30, Novolin® 70/30);
- Regimen 3 - a short-acting insulin analog (i.e., Humalog®-Lispro, NovoLog®-Aspart, Apidra®-Glulisine) before each meal and are treated with a single injection of the long-acting insulin analog Lantus® (Glargine) per day and do not utilize an insulin/carbohydrate ratio for calculating their short-acting insulin doses; or
- Regimen 4 - with a short-acting insulin analog (i.e., Humalog®-Lispro, NovoLog®-Aspart, Apidra®-Glulisine) before each meal and a single injection of the long-acting insulin analog Lantus® (Glargine) per day and utilize an insulin/carbohydrate ratio for calculating their short-acting insulin doses.
- On same insulin regimen for the previous 3-months
- May be using other diabetes agents at a stable dose for the last 3-months
- Signed and dated informed consent document, which contains HIPAA waiver information informing about all of the aspects of the clinical study;
Will regularly conduct Self-Monitored Blood Glucose. Prior to randomization must meet the following .
Minimum number of tests required from all subjects:
- Basal insulin subjects at least 4 fasting glucose readings/wk
- Premixed insulin subjects at least 8 readings/wk
- Basal-bolus insulin therapy subjects at least 16 total readings/wk
Willing and able to comply with the scheduled clinical study activities and glucose testing:
- Basal insulin subjects at least 5 fasting glucose readings/wk
- Premixed insulin subjects at least 5 pre-breakfast and 5 pre-evening meal readings/wk
- Basal-bolus insulin therapy subjects at least 20 total readings/wk which include 5 readings before each of the following time points: breakfast, lunch, evening meal and bedtime.
Note: All subjects may be asked to test during the night if clinically indicated.
- Participant must have a primary care provider
Exclusion Criteria:
- History >2 episodes of severe hypoglycemia (see definition below) in the past year, or hypoglycemic unawareness when glucose levels are ≤ 50 mg/dl;
- Significant physical, psychological, or cognitive impairment that would prohibit adherence to the protocol at the discretion of the PI;
- Splitting Lantus and taking Lantus twice a day
- Severe cardiovascular disease including a history of congestive heart failure, unstable angina, myocardial infarction or stroke within the 6-months preceding enrollment;
- Active anemia w/ hematocrit ≤ 25% in women or 30% in men;
- Advanced kidney disease Stage 4 (eGFR < 30 ml/min) and above
- Active cancer or cancer in the past 2-years (except non-melanoma skin cancer)
- History of significant liver disease including cirrhosis or elevated liver enzymes (e.g., AST and ALT greater than 3 times the upper limit of normal values).
- BMI > 45 kg/m2
- Are pregnant, plan to become pregnant during the study period, or are breastfeeding.
- Have a BGMS that cannot be downloaded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: d-Nav Device
d-Nav Device: daily use to provide insulin dosage updates weekly - or sooner when needed based on analyzes and evaluates the historical blood glucose patterns. Insulin dosage is adjusted as required |
Insulin dosage is adjusted as required
|
Active Comparator: Blood Glucose Monitoring System
Patient's personal Over the Counter Blood Glucose Monitoring System (OTC BGMS) for daily glucose testing to determine insulin dosage needed. Insulin dosage is adjusted as required |
Insulin dosage is adjusted as required
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in HbA1C
Time Frame: 6 months
|
To demonstrate a greater reduction in HbA1c at 6-months for d-Nav users compared to control patients in the primary cohort.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison Percent Reduction HbA1c
Time Frame: 6 months
|
To determine the difference between the Control and d-Nav group in the percent of participants who achieve A1c < 7.0%, < 8.0%, and >9.0% at 6 months
|
6 months
|
Number of Glucose Readings <70 mg/dl
Time Frame: 3 and 6 months
|
To determine the difference between the Control and d-Nav group in the number of glucose readings <70 mg/dl (symptomatic or asymptomatic) utilizing the documented downloaded glucose values.
|
3 and 6 months
|
Change in Rate of Hypoglycemia
Time Frame: 6 months
|
To determine change (if any) in rate of hypoglycemia, during the study for d-Nav users in the secondary cohort
|
6 months
|
Comparison Percent Reduction HbA1c w/out Hypoglycemia
Time Frame: 6 months
|
To determine the difference between the Control and d-Nav group in the percent of participants who achieve A1c < 7.0%, < 8.0% without a severe hypoglycemia event at 6 months.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard M Bergenstal, MD, Executive Director International Diabetes Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PD004-1
- 5R42DK085974-03 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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