Efficacy and Safety of Frequently Modified Intensive Insulin

Completed · Not applicable

Conditions studied: Diabetes

In brief

The purpose of this study is to evaluate the efficacy and safety of frequently modified intensive insulin therapy in patients with Type-2 and Type-1 diabetes mellitus.

Key facts

Study ID

NCT01014832

Run by

Hygieia, Inc

People needed

14

Starts

2008-12-01

Expected to finish

2009-08-01

Last updated by the study team

2009-11-17

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals eligible for inclusion in the study are those who:
• are male or female, 25 to 65 years of age;
• are of any ethnic background;
• meet the criteria for either population I or population II;
• if a female of child-bearing potential will submit to a urine pregnancy test (UPT) at Visit 1;
• can provide their previous 12 months of lab results (at least one set of blood count, kidney functions, and liver enzymes); and
• read, understand, and sign an informed consent document which contains a Health Information Portability and Accountability Act (HIPAA) authorization after being advised of the nature of the study.
• Population I inclusion criteria:
• Individuals eligible for inclusion in population I are those who:
• meet the standard criteria for enrollment in the study;
• have been clinically diagnosed compatible with Type-2 diabetes for at least 1 year;
• take insulin injections for the past 6 months;
• have or have not been using an oral agent within the past 6 months;
• have sufficient medical insurance coverage to cover intensive insulin therapy including Lantus® and Humalog®/Novolog® as well as test-strips cost for testing their blood glucose levels at least 4 times per day;
• are willing to stop anti-diabetic agents (except Metformin);
• are willing to accept intensive insulin therapy with at least 4 daily insulin injections;
• consistently record their glucose measurements and insulin doses in a log book and have their previous readings ready for review; and
• have a Hemoglobin-A1c (HbA1c) of 7.6% or greater, to be drawn at Visit 1.
• Population II inclusion criteria:
• Individuals eligible for inclusion in population II are those who:
• meet the standard criteria for enrollment in the study;
• have been clinically diagnosed compatible with Type-1 diabetes for at least 1 year;
• treated with both long acting insulin analog (ie, Insulin Glargine) and short acting insulin analog (ie, Insulin Lispro or Insulin Aspart) with a total daily insulin dose of 25 units or more
• are currently using carbohydrate counting in their regimen or have been trained to employ this technique during the last 2 years;
• consistently record their glucose measurements and insulin doses in a log book and have their previous readings for review; and

You may not qualify if…

• Individuals excluded from participation in the study are those who:
• have a history of greater than 2 episodes of severe hypoglycemia (See Section 5.4) in the past year or hypoglycemic unawareness;
• have a significant physical, psychological, or cognitive impairment that would prohibit adherence to an intensive insulin therapy program;
• have any severe cardiovascular disease including a history of congestive heart failure (New York Heart Association [NYHA] 3 or 4), unstable angina, myocardial infarction or stroke that occurred within 6 months prior to enrollment
• have a history of severe anemia with a hematocrit less than 25% in women or 30% in men;
• have a history of renal disease (ie, serum creatinine level greater than 2.0 mg/dl);
• have a history of active cancer or cancer in the past 2 years (except non-melanoma skin cancer);
• are receiving chemotherapy or radiation therapy;
• have a history of significant liver disease including cirrhosis or elevated liver function tests (AST and ALT) greater than 3 times the upper limit of normal values;
• have a body mass index (BMI) greater than 45 kg/m2; and/or
• are pregnant, plan to become pregnant during the study period, or are breastfeeding.

Where it is running

• TKL Research INC. — Paramus, New Jersey, United States

Full record on ClinicalTrials.gov

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