Status:
COMPLETED
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
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Sanofi
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-55 years
Phase:
NA
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 t...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00927524
Start Date
April 1 2005
End Date
December 1 2010
Last Update
December 11 2014
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