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Insulin Exposure and Glucose Response to Meals in Type 1 Diabetic Subjects Administered Two Different Insulin Regimens Compared to the Endogenous Insulin Exposure and Glucose Response to Meals In Healthy Adult Controls

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Sanofi
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00927524
First received: June 23, 2009
Last updated: June 14, 2010
Last verified: June 2010
History of Changes
  Purpose

Intensive control of Type 1 Diabetes is critical in prevention of long term complications. Unfortunately, there is a three-fold increase in hypoglycemia with intensive control. Hypoglycemia is often the major limiting factor in achieving good control. Insulin treatment of diabetes is composed of some form of short acting insulin regimen in order to provide control of blood glucose excursions that are the result of glucose intake as well as a basal insulin regimen either in a continuous administration (as in continuous subcutaneous insulin infusion-"pump therapy"), once a day injection (insulin Glargine), twice a day (ultralente or NPH or lente insulin) or a premixed version that is combined with the short acting insulin (70/30 or 75/25). Often low blood sugars are the result of less physiologically absorbed insulins whose peak of action is earlier or later than the peak absorption of glucose from a meal.

Apidra (glulisine insulin) is a new short acting insulin analogue whose peak and duration of action are ideal in that it may be administered more appropriately prior to and even after a meal with evidence of good control of blood glucose excursions from a meal. The purpose of this study is to compare the effect of Apidra upon meal related blood glucose profile as compared to those treated with 70/30 insulin in patients with Type 1 Diabetes. The investigators also will study healthy volunteers as controls who will not be treated with insulin but will be evaluated for mealtime absorption and blood glucose profile during similar meal intake. The investigators will use a stable isotope tritiated glucose.


Condition Intervention
Type 1 Diabetes
 Drug: Insulin glulisine
Drug: Insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Two-Period, Crossover Study to Characterize the Insulin Exposure and Glucose Response to Meals in Type 1 Diabetic Subjects Administered Two Different Insulin Regimens Compared to the Endogenous Insulin Exposure and Glucose Response to Meals In Healthy Adult Controls

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Insulin levels [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2005
Estimated Study Completion Date: December 2010
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Apidra (insulin glulisine)
Administration of Apidra at three meals during a 24 hour period.
 Drug: Insulin glulisine
Dose injection of insulin glargine (Lantus®) given subcutaneously in the abdomen 1 hour prior to breakfast and a dose of insulin glulisine (Apidra®) at a dose based upon your (body wt.) carbohydrate intake for each of the three meals (breakfast, lunch and dinner).
Other Name: Apidra
Active Comparator: 70/30 insulin
Administration of 73/30 insulin at three meals during a 24 hour period.
 Drug: Insulin
Dose based on carbohydrate intake given subcutaneously in the abdomen prior to breakfast and dinner.
Other Name: Humalog 70/30

Detailed Description:

Intensive control of Type 1 Diabetes is critical in prevention of long term complications. Unfortunately, there is a three-fold increase in hypoglycemia with intensive control. Hypoglycemia is often the major limiting factor in achieving good control. Insulin treatment of diabetes is composed of some form of short acting insulin regimen in order to provide control of blood glucose excursions that are the result of glucose intake as well as a basal insulin regimen either in a continuous administration (as in continuous subcutaneous insulin infusion-"pump therapy"), once a day injection (insulin Glargine), twice a day (ultralente or NPH or lente insulin) or a premixed version that is combined with the short acting insulin (70/30 or 75/25). Often low blood sugars are the result of less physiologically absorbed insulins whose peak of action is earlier or later than the peak absorption of glucose from a meal.

Apidra (glulisine insulin) is a new short acting insulin analogue whose peak and duration of action are ideal in that it may be administered more appropriately prior to and even after a meal with evidence of good control of blood glucose excursions from a meal. The purpose of this study is to compare the effect of Apidra upon meal related blood glucose profile as compared to those treated with 70/30 insulin in patients with Type 1 Diabetes. We also will study healthy volunteers as controls who will not be treated with insulin but will be evaluated for mealtime absorption and blood glucose profile during similar meal intake. We will use a stable isotope tritiated glucose.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diabetic Subjects

    1. 12 adults (males or females) with Type 1 Diabetes, aged 18 to 55 years.
    2. C-peptide-negative
    3. Body mass index < 29.0 kg/m2

  • Healthy Subjects

    1. 12 non-smoking adults (males or females), aged 18 to 55 years
    2. Normal response to an oral glucose tolerance test (OGTT)
    3. Body mass index < 29.0 kg/m2

Exclusion Criteria:

  • Diabetic Subjects

    1. Hemoglobin A1c >9%
    2. Total daily insulin requirements >0.8 units/kg actual body weight
    3. History of hypoglycemia that required the subject to see medical attention (i.e., doctor's office visit, ER visit, or EMT/paramedic attention) within 6 months of the study.
    4. History of acute metabolic complications within 3 months of the study
    5. History of lipodystrophy.
    6. History of or suspected diabetic gastroparesis or current treatment with any drugs known to affect gastrointestinal motility.
    7. Inability or unwillingness to administer subcutaneous insulin injections in the abdomen.
    8. Any past or present clinically relevant abnormality, medical condition, or circumstance making the subject unsuitable for participation in the study.
    9. Active peptic ulcer disease or a history of gastrointestinal surgery within the last 6 months years.
    10. History of malignancy (except basal cell carcinoma and carcinoma in situ) within the last 5 years.
    11. Pregnant or lactating females or females of childbearing potential who are unwilling to abstain from sexual intercourse or use reliable, medically accepted methods of contraception.
    12. History of alcoholism or drug abuse within 12 months of the study.
    13. Is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, other study staff, or relative thereof directly involved in the conduct of this protocol.

  • Healthy Subjects

    1. Hemoglobin A1c >6.0%
    2. Any past or present clinically relevant abnormality, medical condition, or circumstance making the subject unsuitable for participation in the study.
    3. Historical, clinical, or laboratory evidence of liver disease including but not limited to transaminase activity concentrations >2.5 times the upper limit of the reference range.
    4. Current treatment with any drugs known to affect gastrointestinal motility.
    5. Active peptic ulcer disease or a history of gastrointestinal surgery within the last 6 months.
    6. History of malignancy (except basal cell carcinoma and carcinoma in situ) within the last 5 years.
    7. Pregnant or lactating females or females of childbearing potential who are unwilling to abstain from sexual intercourse or use reliable, medically accepted methods of contraception.
    8. History of alcoholism or drug abuse within 12 months of the study.
    9. Is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, other study staff, or relative thereof directly involved in the conduct of this protocol.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Stephen N. Davis, MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00927524     History of Changes
Other Study ID Numbers: 050116
Study First Received: June 23, 2009
Last Updated: June 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Insulin analogs
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin glulisine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013