New Onset Type 1 Diabetes: Role of Exenatide

• Sponsor: Albert Einstein College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01269034
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 13
• Location: 1
• Arms: 4
• Duration (Months): 74
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Drug: Exenatide; Drug: Rapid and long acting insulin; Drug: long acting insulin + rapid acting + 1.25 mcg Exenatide	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: New Onset Type 1 Diabetes: Role of Exenatide
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Jan 31, 2017
• Actual Study Completion Date: Jan 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A Exenatide and long acting insulin before the boost.	Drug: Exenatide; 1.25 mcg before the boost sub-cutaneously.; Other Names: 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; Other Names: Novolog/ Humalog Lantus/ Levemir
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.; Other Names: Lantus Levemir
No Intervention: Healthy controls healthy controls without any medication before the boost.

Outcome Measures

Primary Outcome Measures

1. The Role of Exenatide as Compared to Insulin Monotherapy in Reducing Postprandial Hyperglycemia. [February 2013]

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

Secondary Outcome Measures

1. The Role of Exenatide on Postprandial Glucagon and Gastric Emptying. [February 2013]

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

2. Postprandial Glucose Excursions, Glucagon Concentrations and Gastric Emptying in Normal Healthy Controls. [February 2013]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Albert Einstein CRC- West Campus	Bronx	New York	United States	10467

Sponsors and Collaborators

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

Investigators

• Study Director: Ranjitha Katikaneni, MB; BS, Montefiore Children's hospital

Study Documents (Full-Text)

• Study Protocol - Apr 27, 2015

More Information

Publications

None provided.

• Responsible Party: Albert Einstein College of Medicine
• ClinicalTrials.gov Identifier: NCT01269034
• Other Study ID Numbers: 2010-435; 3R01DK077166-05S1
• First Posted: Jan 4, 2011
• Last Update Posted: Aug 4, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Albert Einstein College of Medicine: Type 1 diabetes Milletus; diabetes; healthy controls; exenatide; byetta
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Insulin; Insulin, Globin Zinc; Exenatide; Insulin Glargine; Insulin Detemir; Insulin, Long-Acting

Study Results

Participant Flow

Recruitment Details	A total of 13 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.
Pre-assignment Detail	"Each participant only received one part (A,B, or C) and did not cross over to the subsequent parts

Arm/Group Title	Part A	Part B	Part C	Healthy Controls
Arm/Group Description	Exenatide and long acting insulin before the boost. Exenatide: 1.25 mcg before the boost sub-cutaneously.	Rapid and long acting insulin before the boost Rapid and long acting insulin: Depends on their Carbohydrate ratio and body needs	long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost long acting insulin + rapid acting + 1.25 mcg Exenatide: Depends on their body needs.	healthy controls without any medication before the boost.
Period Title: Overall Study
STARTED	1	2	1	9
COMPLETED	0	2	1	9
NOT COMPLETED	1	0	0	0

Baseline Characteristics

Arm/Group Title	Part A	Part B	Part C	Healthy Controls	Total
Arm/Group Description	Exenatide and long acting insulin before the boost. Exenatide: 1.25 mcg before the boost sub-cutaneously.	Rapid and long acting insulin before the boost Rapid and long acting insulin: Depends on their Carbohydrate ratio and body needs	long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost long acting insulin + rapid acting + 1.25 mcg Exenatide: Depends on their body needs.	healthy controls without any medication before the boost.	Total of all reporting groups
Overall Participants	1	2	1	9	13
Age (Count of Participants)
<=18 years	0 0%	1 50%	1 100%	6 66.7%	8 61.5%
Between 18 and 65 years	1 100%	1 50%	0 0%	3 33.3%	5 38.5%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	1 100%	1 50%	0 0%	5 55.6%	7 53.8%
Male	0 0%	1 50%	1 100%	4 44.4%	6 46.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 100%	1 50%	0 0%	5 55.6%	7 53.8%
Not Hispanic or Latino	0 0%	1 50%	1 100%	4 44.4%	6 46.2%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	1 11.1%	1 7.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%
White	1 100%	2 100%	1 100%	8 88.9%	12 92.3%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	The Role of Exenatide as Compared to Insulin Monotherapy in Reducing Postprandial Hyperglycemia.
Description	Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Time Frame	February 2013

Outcome Measure Data

Analysis Population Description

The original PI and their entire team left the institution. Despite repeated efforts to contact the PI and study team members, the PI and study team members refused to disclose any collected data. Additionally, no secondary information sources such as study publications exist from which to summarize collected data

Arm/Group Title	Part A	Part B	Part C	Healthy Controls
Arm/Group Description	Exenatide and long acting insulin before the boost. Exenatide: 1.25 mcg before the boost sub-cutaneously.	Rapid and long acting insulin before the boost Rapid and long acting insulin: Depends on their Carbohydrate ratio and body needs	long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost long acting insulin + rapid acting + 1.25 mcg Exenatide: Depends on their body needs.	healthy controls without any medication before the boost.
Measure Participants	0	0	0	0

2. Secondary Outcome

Title	The Role of Exenatide on Postprandial Glucagon and Gastric Emptying.
Description	Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Time Frame	February 2013

Outcome Measure Data

Analysis Population Description

The original PI and their entire team left the institution. Despite repeated efforts to contact the PI and study team members, the PI and study team members refused to disclose any collected data. Additionally, no secondary information sources such as study publications exist from which to summarize collected data.

Arm/Group Title	Part A	Part B	Part C	Healthy Controls
Arm/Group Description	Exenatide and long acting insulin before the boost. Exenatide: 1.25 mcg before the boost sub-cutaneously.	Rapid and long acting insulin before the boost Rapid and long acting insulin: Depends on their Carbohydrate ratio and body needs	long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost long acting insulin + rapid acting + 1.25 mcg Exenatide: Depends on their body needs.	healthy controls without any medication before the boost.
Measure Participants	0	0	0	0

3. Secondary Outcome

Title	Postprandial Glucose Excursions, Glucagon Concentrations and Gastric Emptying in Normal Healthy Controls.
Description	Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Time Frame	February 2013

Outcome Measure Data

Analysis Population Description

The original PI and their entire team left the institution. Despite repeated efforts to contact the PI and study team members, the PI and study team members refused to disclose any collected data. Additionally, no secondary information sources such as study publications exist from which to summarize collected data.

Arm/Group Title	Part A	Part B	Part C	Healthy Controls
Arm/Group Description	Exenatide and long acting insulin before the boost. Exenatide: 1.25 mcg before the boost sub-cutaneously.	Rapid and long acting insulin before the boost Rapid and long acting insulin: Depends on their Carbohydrate ratio and body needs	long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost long acting insulin + rapid acting + 1.25 mcg Exenatide: Depends on their body needs.	healthy controls without any medication before the boost.
Measure Participants	0	0	0	0

Adverse Events

Time Frame	6 years
Adverse Event Reporting Description	While Adverse Events were monitored/assessed, none were observed
Arm/Group Title	Part A		Part B		Part C		Healthy Controls
Arm/Group Description	Exenatide and long acting insulin before the boost. Exenatide: 1.25 mcg before the boost sub-cutaneously.		Rapid and long acting insulin before the boost Rapid and long acting insulin: Depends on their Carbohydrate ratio and body needs		long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost long acting insulin + rapid acting + 1.25 mcg Exenatide: Depends on their body needs.		healthy controls without any medication before the boost.
All Cause Mortality
	Part A		Part B		Part C		Healthy Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/2 (0%)		0/1 (0%)		0/9 (0%)
Serious Adverse Events
	Part A		Part B		Part C		Healthy Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/2 (0%)		0/1 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Part A		Part B		Part C		Healthy Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/2 (0%)		0/1 (0%)		0/9 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.