New Onset Type 1 Diabetes: Role of Exenatide

This study is currently recruiting participants.
Verified January 2014 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rubina Heptulla, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01269034
First received: December 29, 2010
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
New Onset Type 1 Diabetes
Drug: Exenatide
Drug: Rapid and long acting insulin
Drug: long acting insulin + rapid acting + 1.25 mcg Exenatide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: New Onset Type 1 Diabetes: Role of Exenatide

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • The role of exenatide as compared to insulin monotherapy in reducing postprandial hyperglycemia. [ Time Frame: February 2013 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The role of exenatide on postprandial glucagon and gastric emptying. [ Time Frame: February 2013 ] [ Designated as safety issue: No ]
  • Postprandial glucose excursions, glucagon concentrations and gastric emptying in normal healthy controls. [ Time Frame: February 2013 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: December 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A (Exenatide and long acting insulin)
This group gets Exenatide and long acting insulin before the boost.
Drug: Exenatide
1.25 mcg before the boost sub-cutaneously.
Other Names:
  • Byetta
  • Exenatide
Active Comparator: Part B (rapid and long acting insulin)
This group gets Rapid acting and long acting insulin before the boost.
Drug: Rapid and long acting insulin
Depends on their Carbohydrate ratio and body needs
Other Names:
  • Novolog/ Humalog
  • Lantus/ Levemir
Active Comparator: Part C (long acting insulin only)
This group gets long acting insulin only before the boost.
Drug: long acting insulin + rapid acting + 1.25 mcg Exenatide
Depends on their body needs.
Other Names:
  • Lantus
  • Levemir
No Intervention: Healthy control Arm
These are healthy controls who do not get any medication before the boost.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269034

Contacts
Contact: Jeniece Trast, RN,CDE 718-920-6191 jtrast@montefiore.org
Contact: Venkat Renukuntla, MBBS, MPH 718-920-7004 vrenukun@montefiore.org

Locations
United States, New York
Albert Einstein CRC- West Campus Recruiting
Bronx, New York, United States, 10467
Sub-Investigator: Mariam Gangat, MD         
Principal Investigator: Rubina A Heptulla, MD         
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Rubina A Heptulla, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Rubina Heptulla, Division Chief of Pediatric Endocrinology & Diabetes, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01269034     History of Changes
Other Study ID Numbers: 2010 -435
Study First Received: December 29, 2010
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
New onset type 1 diabetes
diabetes
healthy controls
exenatide
byetta

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Exenatide
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014