Efficacy and Safety of Frequently Modified Intensive Insulin

NCT01014832 | Completed

• 2 other identifiers: Hygieia study -2CS950308
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes

Keywords

Diabetes, insulin.

Outcome Measures

Primary Outcomes (3)

• Hemoglobin A1C

  12 weeks

• Mean weekly glucose

  12 weeks

• Frequency of hypoglycemia

  12 weeks

Study Arms (1)

Uncontrolled diabetes

EXPERIMENTAL

Uncontrolled diabetes

Drug: Intensive insulin therapy

Interventions

Intensive insulin therapy DRUG

Intensive insulin therapy

Also known as: Basal-bolus insulin therapy

Uncontrolled diabetes

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

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.

Sponsors & Collaborators

• Hygieia, Inc: lead
• TKL Research, Inc.: collaborator

Study Sites (1)

TKL Research INC.

Paramus, New Jersey, 07652, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Israel Hodish, MD. PhD.

  Hygieia, Inc

  STUDY DIRECTOR

• Michael Casser, MD

  TKL Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: November 17, 2009
• Study Start: December 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 17, 2009

Record last verified: 2009-11

Locations

US (1)