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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014