Multi-Center Study Comparing Efficacy and Safety of Frequently Modified Insulin Therapy

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2, Hypoglycemia

In brief

Hygieia Research seeks to conduct a prospective randomized clinical study involving adult subjects with uncontrolled Type-2 diabetes requiring insulin. The study seeks to demonstrate that the clinical application of the d-Nav will achieve metabolic control in a safe and effective manner.

Key facts

Study ID

NCT02424500

Run by

Hygieia Research LLC

People needed

181

Starts

2015-01-01

Expected to finish

2017-06-30

Last updated by the study team

2019-02-27

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Park Nicollet Institute / International Diabetes Center, Minneapolis, MN — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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