Efficacy and Safety of Frequently Modified Intensive Insulin

This study has been completed.
Sponsor:
Collaborator:
TKL Research, Inc.
Information provided by:
Hygieia, Inc
ClinicalTrials.gov Identifier:
NCT01014832
First received: November 13, 2009
Last updated: November 16, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention
Diabetes
Drug: Intensive insulin therapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Efficacy and Safety Evaluation of Frequently Modified Intensive Insulin Therapy in Subjects With Uncontrolled Type-I or Type-2 Diabetes

Resource links provided by NLM:


Further study details as provided by Hygieia, Inc:

Primary Outcome Measures:
  • Hemoglobin A1C [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Mean weekly glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Frequency of hypoglycemia [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: December 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Uncontrolled diabetes
Uncontrolled diabetes
Drug: Intensive insulin therapy
Intensive insulin therapy
Other Name: Basal-bolus insulin therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014832

Locations
United States, New Jersey
TKL Research INC.
Paramus, New Jersey, United States, 07652
Sponsors and Collaborators
Hygieia, Inc
TKL Research, Inc.
Investigators
Study Director: Israel Hodish, MD. PhD. Hygieia, Inc
Principal Investigator: Michael Casser, MD TKL Research, Inc.
  More Information

No publications provided

Responsible Party: Israel Hodish MD. PhD., Hygieia INC.
ClinicalTrials.gov Identifier: NCT01014832     History of Changes
Other Study ID Numbers: Hygieia study -2, CS950308
Study First Received: November 13, 2009
Last Updated: November 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Hygieia, Inc:
Diabetes, insulin.

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014