New Onset Type 1 Diabetes: Role of Exenatide

NCT ID: NCT01269034

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2017-01-31

Brief Summary

There are many recent advances in insulin treatment of type 1 diabetes, however after a meal sugars are always a concern. There is a drug Exenatide (Byetta) which is FDA approved to treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals. This study is going to test whether this drug can improve the after meal sugars in people with new onset type 1 diabetes. To test this you will be given a dose of exenatide (1.25 mcg) and long acting insulin or inulin alone before the boost. There is also a placebo group (healthy subjects) who do not get any medication before the boost. Insulin levels and other hormones that affect blood glucose as well as your sugar will be measured by a series of blood tests. The role exenatide as compared to insulin alone will be examined to prevent low blood sugars which might occur because of food staying longer in the stomach than usual or due to the suppression of a hormone called glucagon which increases blood sugar. If you qualify you will be given exenatide (Byetta 1.25 mcg) along with insulin or insulin alone. You and the researchers will not know which dose you are taking at any single visit. A total of 20 people in which some will be children aged 12- 18 years will participate, being diagnosed within 3 months of having been found to have type 1 diabetes.

Detailed Description

The specific aims of this study are to determine the following:

1. The role of exenatide as compared to insulin monotherapy in reducing postprandial hyperglycemia.

2. The role of exenatide on postprandial glucagon and gastric emptying.

3. The effect of long acting insulin on postprandial glucose excursions, glucagon concentrations and gastric emptying.

4. Postprandial glucose excursions, glucagon concentrations and gastric emptying in normal healthy controls.

Study Design:

A randomized, non-blinded trial with a crossover design will be used. Following informed consent and with appropriate subject assent, all subjects will have a screening visit. Following the screening visit, subjects with T1DM will undergo 3 studies: Part A (exenatide and long acting insulin), Part B (rapid and long acting insulin) and Part C (long acting insulin only). The subjects will be admitted to the CRC on three separate occasions, at least 3-4 weeks apart. The three studies will be performed in a random order and the randomization will be done using a computerized system. The healthy controls will undergo a single study visit. Except for the absence of diabetes, the healthy controls will be identical to the study subjects. Subjects with new onset diabetes will be compared to healthy controls.

During the study, if blood glucose values in a subject are less than 55 mg/dl, IV glucose of 5-15 grams will be administered to achieve euglycemia (90-130 mg/dl). 1-2 doses of IV glucose should correct hypoglycemia. If more than 3 doses are required to achieve euglycemia, the study will be terminated, the subject will be offered a meal tray and blood sugar rechecked to ensure euglycemia. If blood sugar at any time is more than 350 with moderate ketones, the study will be terminated.

At around 1 PM (270 min), lunch will be provided (consistent carbohydrate meal) and insulin will be given as per the subject's prescribed regimen. The subject will be discharged home with a designated driver due to the risk of hypoglycemia.

A subject will be withdrawn from participating in the study if he/she meets any of the following conditions: 1)develops a chronic disease 2)develops anemia 3)becomes pregnant 4)develops a weight loss of greater than 10 pounds for unspecified reasons 5)loss of contact- if the investigators are unable to reach a study subject (within 2 months of screening or completion of the first study) by phone or mail to schedule the next appointment. All study subjects (that are withdrawn from the study) will receive a phone call and a letter notifying them that they have been withdrawn.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A

Exenatide and long acting insulin before the boost.

Group Type: EXPERIMENTAL

Exenatide

Intervention Type: DRUG

1.25 mcg before the boost sub-cutaneously.

Part B

Rapid and long acting insulin before the boost

Group Type: ACTIVE_COMPARATOR

Rapid and long acting insulin

Intervention Type: DRUG

Depends on their Carbohydrate ratio and body needs

Part C

long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost

Group Type: ACTIVE_COMPARATOR

long acting insulin + rapid acting + 1.25 mcg Exenatide

Intervention Type: DRUG

Depends on their body needs.

Healthy controls

healthy controls without any medication before the boost.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exenatide

1.25 mcg before the boost sub-cutaneously.

Intervention Type: DRUG

Rapid and long acting insulin

Depends on their Carbohydrate ratio and body needs

Intervention Type: DRUG

long acting insulin + rapid acting + 1.25 mcg Exenatide

Depends on their body needs.

Intervention Type: DRUG

Other Intervention Names

Byetta; Novolog/ Humalog; Lantus/ Levemir; Lantus; Levemir

Eligibility Criteria

Inclusion Criteria

1. Age between 12-18 years of age at the time of enrollment.

2. Diagnosed with antibody positive T1DM in the past 3 months.

3. Otherwise healthy except for their TIDM and treated hypothyroidism.

4. Females must have a negative pregnancy test.

5. Hemoglobin equal to or greater than 12 g/dl before each study.

6. Weight greater than 44 kg.

Exclusion Criteria

1. Any chronic disease: leukemia, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis etc, except for diabetes and hypothyroidism.

2. Any medications that may affect glucose metabolism.

3. Abnormal AST, ALT, amylase, lipase, creatinine (more than 3 times normal values).

4. Lack of a supportive family environment as detected by the clinicians and/or social workers.

5. History of substance abuse (evaluated by medical history and CRAFFT questionnaire which will be administered at the screening visit).

6. Positive pregnancy test in females.

7. Lactating and nursing mothers.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ranjitha Katikaneni, MB; BS

Role: STUDY_DIRECTOR

Montefiore Children's hospital

Locations

Albert Einstein CRC- West Campus

The Bronx, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

3R01DK077166-05S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2010-435

Identifier Type: -

Identifier Source: org_study_id