New Onset Type 1 Diabetes: Role of Exenatide

NCT01269034 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 2010-4353R01DK077166-05S1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes Milletus; diabetes; healthy controls; exenatide; byetta

Outcome Measures

Primary Outcomes (1)

• The Role of Exenatide as Compared to Insulin Monotherapy in Reducing Postprandial Hyperglycemia.

  Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.

  February 2013

Secondary Outcomes (2)

• The Role of Exenatide on Postprandial Glucagon and Gastric Emptying.

  February 2013

• Postprandial Glucose Excursions, Glucagon Concentrations and Gastric Emptying in Normal Healthy Controls.

  February 2013

Study Arms (4)

Part A

EXPERIMENTAL

Exenatide and long acting insulin before the boost.

Drug: Exenatide

Part B

ACTIVE COMPARATOR

Rapid and long acting insulin before the boost

Drug: Rapid and long acting insulin

Part C

ACTIVE COMPARATOR

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

Drug: long acting insulin + rapid acting + 1.25 mcg Exenatide

Healthy controls

NO INTERVENTION

healthy controls without any medication before the boost.

Interventions

Exenatide DRUG

1.25 mcg before the boost sub-cutaneously.

Also known as: Byetta

Part A

Rapid and long acting insulin DRUG

Depends on their Carbohydrate ratio and body needs

Also known as: Novolog/ Humalog, Lantus/ Levemir

Part B

long acting insulin + rapid acting + 1.25 mcg Exenatide DRUG

Depends on their body needs.

Also known as: Lantus, Levemir

Part C

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 12-18 years of age at the time of enrollment.
• Diagnosed with antibody positive T1DM in the past 3 months.
• Otherwise healthy except for their TIDM and treated hypothyroidism.
• Females must have a negative pregnancy test.
• Hemoglobin equal to or greater than 12 g/dl before each study.
• Weight greater than 44 kg.

You may not qualify if:

• Any chronic disease: leukemia, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis etc, except for diabetes and hypothyroidism.
• Any medications that may affect glucose metabolism.
• Abnormal AST, ALT, amylase, lipase, creatinine (more than 3 times normal values).
• Lack of a supportive family environment as detected by the clinicians and/or social workers.
• History of substance abuse (evaluated by medical history and CRAFFT questionnaire which will be administered at the screening visit).
• Positive pregnancy test in females.
• Lactating and nursing mothers.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Albert Einstein CRC- West Campus

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

Exenatide; Insulin, Long-Acting; Insulin Aspart; Insulin Lispro; Insulin Glargine; Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Insulin, Short-Acting

Limitations and Caveats

The original PI and their entire team has left the institution. Repeated attempts for complete data have gone unanswered. Outcome measure data is not available to provide full and complete results.

Results Point of Contact

• Title: Roger Hicks, Administrative Director for Research - Department of Pediatrics
• Organization: Albert Einstein College of Medicine

roger.hicks@einsteinmed.org

718-920-7386

Study Officials

• Ranjitha Katikaneni, MB; BS

  Montefiore Children's hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: January 4, 2011
• Study Start: December 1, 2010
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: August 4, 2021
• Results First Posted: August 4, 2021

Record last verified: 2021-07

Locations

US (1)