Type 1 DiabetesNCT00927524
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
A study testing Insulin glulisine and Insulin in people with Type 1 Diabetes, run by Vanderbilt University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Insulin glulisine and Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 24Show fewer
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Insulin glulisine, Insulin
- Keywords
- Insulin analogs, diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glulisineDrug
Also called Apidra
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).
InsulinDrug
Also called Humalog 70/30
Dose based on carbohydrate intake given subcutaneously in the abdomen prior to breakfast and dinner.
| Study group | Role | What they receive |
|---|---|---|
| Apidra (insulin glulisine) | Active comparator | Administration of Apidra at three meals during a 24 hour period. Receives: Drug: Insulin glulisine |
| 70/30 insulin | Active comparator | Administration of 73/30 insulin at three meals during a 24 hour period. Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin levels
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startApr 2005
- Primary completionApr 2006
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Steve Davis, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927524
- Sponsor's protocol ID
- 050116
- Status last verified
- Dec 2014
- First submitted
- 23 Jun 2009
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00927524
- Acronym / sponsor ID
- 050116
- Conditions
- Type 1 Diabetes
- Keywords
- Insulin analogs, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Apr 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apidra (insulin glulisine) | Active comparator | Drug: Insulin glulisineAdministration of Apidra at three meals during a 24 hour period. |
| 70/30 insulin | Active comparator | Drug: InsulinAdministration of 73/30 insulin at three meals during a 24 hour period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Diabetic Subjects
- Healthy Subjects
Key exclusion criteria (24 listed)
- Diabetic Subjects
- Healthy Subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin glulisineAlso: ApidraDose 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). | Drug | Apidra (insulin glulisine) |
| InsulinAlso: Humalog 70/30Dose based on carbohydrate intake given subcutaneously in the abdomen prior to breakfast and dinner. | Drug | 70/30 insulin |
Primary outcome
Insulin levels
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin glulisine and Insulin in people with Type 1 Diabetes, run by Vanderbilt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin levels (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2014.