New Onset Type 1 Diabetes: Role of Exenatide
|Type 1 Diabetes||Drug: Exenatide Drug: Rapid and long acting insulin Drug: long acting insulin + rapid acting + 1.25 mcg Exenatide||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||New Onset Type 1 Diabetes: Role of Exenatide|
- The role of exenatide as compared to insulin monotherapy in reducing postprandial hyperglycemia. [ Time Frame: February 2013 ]
- The role of exenatide on postprandial glucagon and gastric emptying. [ Time Frame: February 2013 ]
- Postprandial glucose excursions, glucagon concentrations and gastric emptying in normal healthy controls. [ Time Frame: February 2013 ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Part A
Exenatide and long acting insulin before the boost.
1.25 mcg before the boost sub-cutaneously.
Other Name: Byetta
Active Comparator: Part B
Rapid and long acting insulin before the boost
Drug: Rapid and long acting insulin
Depends on their Carbohydrate ratio and body needs
Active Comparator: Part C
long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost
Drug: long acting insulin + rapid acting + 1.25 mcg Exenatide
Depends on their body needs.
No Intervention: Healthy controls
healthy controls without any medication before the boost.
The specific aims of this study are to determine the following:
- The role of exenatide as compared to insulin monotherapy in reducing postprandial hyperglycemia.
- The role of exenatide on postprandial glucagon and gastric emptying.
- The effect of long acting insulin on postprandial glucose excursions, glucagon concentrations and gastric emptying.
- Postprandial glucose excursions, glucagon concentrations and gastric emptying in normal healthy controls.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269034
|Contact: Ranjitha Katikaneni, MB;BSemail@example.com|
|Contact: Ranjitha Katikaneni, MB;BSfirstname.lastname@example.org|
|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|
|Principal Investigator:||Rubina A Heptulla, MD||Albert Einstein College of Medicine, Inc.|