Efficacy and Safety of Frequently Modified Intensive Insulin

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hygieia, Inc
• Collaborator: TKL Research, Inc.
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

Individuals eligible for inclusion in the study are those who:

1. are male or female, 25 to 65 years of age;

2. are of any ethnic background;

3. meet the criteria for either population I or population II;

4. if a female of child-bearing potential will submit to a urine pregnancy test (UPT) at Visit 1;

5. can provide their previous 12 months of lab results (at least one set of blood count, kidney functions, and liver enzymes); and

6. 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:

1. meet the standard criteria for enrollment in the study;

2. have been clinically diagnosed compatible with Type-2 diabetes for at least 1 year;

3. take insulin injections for the past 6 months;

4. have or have not been using an oral agent within the past 6 months;

5. 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;

6. are willing to stop anti-diabetic agents (except Metformin);

7. are willing to accept intensive insulin therapy with at least 4 daily insulin injections;

8. consistently record their glucose measurements and insulin doses in a log book and have their previous readings ready for review; and

9. 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:

1. meet the standard criteria for enrollment in the study;

2. have been clinically diagnosed compatible with Type-1 diabetes for at least 1 year;

3. 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

4. are currently using carbohydrate counting in their regimen or have been trained to employ this technique during the last 2 years;

5. consistently record their glucose measurements and insulin doses in a log book and have their previous readings for review; and

6. have a HbA1c of 7.6% or greater, to be drawn at Visit 1.

Exclusion Criteria:

Individuals excluded from participation in the study are those who:

1. have a history of greater than 2 episodes of severe hypoglycemia (See Section 5.4) in the past year or hypoglycemic unawareness;

2. have a significant physical, psychological, or cognitive impairment that would prohibit adherence to an intensive insulin therapy program;

3. 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

4. have a history of severe anemia with a hematocrit less than 25% in women or 30% in men;

5. have a history of renal disease (ie, serum creatinine level greater than 2.0 mg/dl);

6. have a history of active cancer or cancer in the past 2 years (except non-melanoma skin cancer);

7. are receiving chemotherapy or radiation therapy;

8. 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;

9. have a body mass index (BMI) greater than 45 kg/m2; and/or

10. are pregnant, plan to become pregnant during the study period, or are breastfeeding.