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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

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Insulin glulisine

Insulin

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Insulin analogs, diabetes

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Apidra (insulin glulisine)

70/30 insulin

Arm Description

Administration of Apidra at three meals during a 24 hour period.

Administration of 73/30 insulin at three meals during a 24 hour period.

Outcomes

Primary Outcome Measures

Insulin levels

Secondary Outcome Measures

Full Information

NCT ID

NCT00927524

First Posted

June 23, 2009

Last Updated

December 10, 2014

Sponsor

Vanderbilt University

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00927524

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

April 2006 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

Insulin analogs, diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apidra (insulin glulisine)

Arm Type

Active Comparator

Arm Description

Administration of Apidra at three meals during a 24 hour period.

Arm Title

70/30 insulin

Arm Type

Active Comparator

Arm Description

Administration of 73/30 insulin at three meals during a 24 hour period.

Intervention Type

Drug

Intervention Name(s)

Insulin glulisine

Other Intervention Name(s)

Apidra

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Insulin

Other Intervention Name(s)

Humalog 70/30

Intervention Description

Dose based on carbohydrate intake given subcutaneously in the abdomen prior to breakfast and dinner.

Primary Outcome Measure Information:

Title

Insulin levels

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diabetic Subjects 12 adults (males or females) with Type 1 Diabetes, aged 18 to 55 years. C-peptide-negative Body mass index < 29.0 kg/m2 Healthy Subjects 12 non-smoking adults (males or females), aged 18 to 55 years Normal response to an oral glucose tolerance test (OGTT) Body mass index < 29.0 kg/m2 Exclusion Criteria: Diabetic Subjects Hemoglobin A1c >9% Total daily insulin requirements >0.8 units/kg actual body weight 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. History of acute metabolic complications within 3 months of the study History of lipodystrophy. History of or suspected diabetic gastroparesis or current treatment with any drugs known to affect gastrointestinal motility. Inability or unwillingness to administer subcutaneous insulin injections in the abdomen. Any past or present clinically relevant abnormality, medical condition, or circumstance making the subject unsuitable for participation in the study. Active peptic ulcer disease or a history of gastrointestinal surgery within the last 6 months years. History of malignancy (except basal cell carcinoma and carcinoma in situ) within the last 5 years. 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. History of alcoholism or drug abuse within 12 months of the study. 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 Hemoglobin A1c >6.0% Any past or present clinically relevant abnormality, medical condition, or circumstance making the subject unsuitable for participation in the study. 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. Current treatment with any drugs known to affect gastrointestinal motility. Active peptic ulcer disease or a history of gastrointestinal surgery within the last 6 months. History of malignancy (except basal cell carcinoma and carcinoma in situ) within the last 5 years. 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. History of alcoholism or drug abuse within 12 months of the study. Is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, other study staff, or relative thereof directly involved in the conduct of this protocol.

12. IPD Sharing Statement

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