Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT01186562
• Collaborator: (none)
• Enrollment: 83
• Location: 1
• Arms: 2
• Duration (Months): 70
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The purpose of the study is to test the effects of sitagliptin on the need for insulin (the hormone that lowers blood sugars) by patients who receive a pancreatectomy and islet autotransplant for chronic pancreatitis.

Condition or Disease	Intervention/Treatment	Phase
Pancreatitis; Diabetes	Drug: Sitagliptin; Drug: Placebo	Phase 4

Detailed Description

At the current time, about one-third of patients are insulin independent (do not need to take insulin) after autotransplant, but the other two-thirds still need some insulin. Sitagliptin works by increasing the amount of a hormone called glucagon-like peptide 1, or GLP-1, in the body which then increases the amount of insulin that is made by the beta cells(the insulin producing cell of the islets). GLP-1 might also help protect beta cells from dying under stressful conditions and increase the production of new beta cells.

The primary goal of this study is to see if taking sitagliptin for one year after islet autotransplant increases the number of patients who achieve and maintain insulin independence. Other goals of this study are to see if sitagliptin reduces the amount of insulin injections needed or helps the islets make more insulin.

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Randomized, Placebo Controlled Intervention Study to Assess the Impact of Sitagliptin 100 mg/Day for 1 Year on Insulin Independence Following Pancreatectomy and Autoislet Transplantation
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sitagliptin	Drug: Sitagliptin; 100 mg PO daily
Placebo Comparator: Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Insulin Independence [12 months]

   percentage of patients insulin independent

Secondary Outcome Measures

1. Insulin Independence [18 months]

   percentage of patients insulin independent

2. Area Under the Curve (AUC) C-peptide (ng/dL*Min) [12 months]

   AUC C-peptide obtained from a mixed meal test (measured time 0 to 2 hours after Boost HP)

3. AUC C-peptide [18 months]

   AUC C-peptide (ng/dL*min) from mixed meal tolerance test (measured times 0 to 2 hours after Boost HP)

4. Acute C-peptide Response (ACR) to Glucose [12 months]

   Derived from intravenous gluocose tolerance testing (0 to 10 minute measures after dextrose bolus)

5. Acute C-peptide Response (ACR) to Glucose [18 months]

   Derived from intravenous glucose tolerance test (0 to 10 minute measures after IV dextrose bolus)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥18 years

• Scheduled for total pancreatectomy and IAT at UM

Exclusion Criteria:

• Pre-existing diabetes mellitus or hyperglycemia with fasting glucose ≥115 mg/dl

• Medical conditions which, in the opinion of the investigator, might impact islet function (e.g asthma or inflammatory disease requiring chronic systemic corticosteroids)

• Significant renal disease: serum creatinine levels of >3.0 mg/dL in men and >2.5 mg/dL in women, or end-stage renal disease requiring hemodialysis or peritoneal dialysis.

• For female subjects, plans to become pregnant or unwillingness to practice birth control for 18 months.

• Islet yield <1,000 IE/kg body weight (exclusion for treatment with drug/placebo)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota

Investigators

• Principal Investigator: Melena Bellin, MD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT01186562
• Other Study ID Numbers: 1006M83756
• First Posted: Aug 23, 2010
• Last Update Posted: May 31, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of Minnesota: Pancreatitis; Pancreatectomy; Islet autotransplant; Sitagliptin; Diabetes
• Additional relevant MeSH terms: Pancreatitis; Sitagliptin Phosphate

Study Results

Participant Flow

Arm/Group Title	Sitagliptin	Placebo
Arm/Group Description	Sitagliptin: 100 mg PO daily	Placebo: Placebo
Period Title: Overall Study
STARTED	54	29
COMPLETED	50	27
NOT COMPLETED	4	2

Baseline Characteristics

Arm/Group Title	Sitagliptin	Placebo	Total
Arm/Group Description	Sitagliptin: 100 mg PO daily	Placebo: Placebo	Total of all reporting groups
Overall Participants	54	29	83
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.0 (11)	42.6 (10.3)	41 (11)
Sex: Female, Male (Count of Participants)
Female	44 81.5%	23 79.3%	67 80.7%
Male	10 18.5%	6 20.7%	16 19.3%
Region of Enrollment (participants) [Number]
United States	54 100%	29 100%	83 100%

Outcome Measures

1. Primary Outcome

Title	Insulin Independence
Description	percentage of patients insulin independent
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

N's reflect patients that returned for study follow up.

Arm/Group Title	Sitagliptin	Placebo
Arm/Group Description	Sitagliptin: 100 mg PO daily	Placebo: Placebo
Measure Participants	50	29
Number [percentage of participants]	42 77.8%	45 155.2%

2. Secondary Outcome

Title	Insulin Independence
Description	percentage of patients insulin independent
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sitagliptin	Placebo
Arm/Group Description	Sitagliptin: 100 mg PO daily	Placebo: Placebo
Measure Participants	50	27
Number [percentage of participants]	36 66.7%	44 151.7%

3. Secondary Outcome

Title	Area Under the Curve (AUC) C-peptide (ng/dL*Min)
Description	AUC C-peptide obtained from a mixed meal test (measured time 0 to 2 hours after Boost HP)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Patients with vomiting, NPO restrictions (due to chronic GI illness) were not able to complete MMTT. The N for each group reflects the number of patients who successfully completed this assessment.

Arm/Group Title	Sitagliptin	Placebo
Arm/Group Description	Sitagliptin: 100 mg PO daily	Placebo: Placebo
Measure Participants	48	27
Mean (Standard Error) [ng*min/dL]	273 (20)	273 (27)

4. Secondary Outcome

Title	AUC C-peptide
Description	AUC C-peptide (ng/dL*min) from mixed meal tolerance test (measured times 0 to 2 hours after Boost HP)
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

Patients with vomiting, NPO (Nothing by Mouth) restrictions (due to chronic GI illness) were not able to complete MMTT. (Mixed meal Tolerance Test) The N for each group reflects the number of patients who successfully completed this assessment.

Arm/Group Title	Sitagliptin	Placebo
Arm/Group Description	Sitagliptin: 100 mg PO daily	Placebo: Placebo
Measure Participants	44	24
Mean (Standard Deviation) [min*ng/dL]	274 (20)	235 (27)

5. Secondary Outcome

Title	Acute C-peptide Response (ACR) to Glucose
Description	Derived from intravenous gluocose tolerance testing (0 to 10 minute measures after dextrose bolus)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

This test required two IVs. In patients for whom 2 IVs could not be placed successfully, this test could not be performed. N's reflect number of patients completing this test.

Arm/Group Title	Sitagliptin	Placebo
Arm/Group Description	Sitagliptin: 100 mg PO daily	Placebo: Placebo
Measure Participants	49	26
Mean (Standard Error) [min*ng/dL]	9.9 (1.2)	7.2 (1.6)

6. Secondary Outcome

Title	Acute C-peptide Response (ACR) to Glucose
Description	Derived from intravenous glucose tolerance test (0 to 10 minute measures after IV dextrose bolus)
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

This test required two IVs. In patients for whom 2 IVs could not be placed successfully, this test could not be performed. N's reflect number of patients completing this test.

Arm/Group Title	Sitagliptin	Placebo
Arm/Group Description	Sitagliptin: 100 mg PO daily	Placebo: Placebo
Measure Participants	46	23
Mean (Standard Error) [min*ng/dL]	6.9 (1.0)	6.0 (1.4)

Adverse Events

Time Frame	18 months
Adverse Event Reporting Description	from treatment start to 18 month follow up
Arm/Group Title	Sitagliptin		Placebo
Arm/Group Description	Sitagliptin: 100 mg PO daily		Placebo: Placebo
All Cause Mortality
	Sitagliptin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Sitagliptin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	31/54 (57.4%)		26/29 (89.7%)
Blood and lymphatic system disorders
Thrombosis Vascular	1/54 (1.9%)		0/29 (0%)
Endocrine disorders
Diabetes Type 1 Endocrine	0/54 (0%)		1/29 (3.4%)
Hyperglycemia Metabolic/Laboratory	0/54 (0%)		1/29 (3.4%)
Hypoglycemia Metabolic/Laboratory	1/54 (1.9%)		3/29 (10.3%)
Gastrointestinal disorders
Abdomen Pain	8/54 (14.8%)		6/29 (20.7%)
Biliary Tree Infection	1/54 (1.9%)		1/29 (3.4%)
Constipation Gastrointestinal	3/54 (5.6%)		3/29 (10.3%)
Dehydration Gastrointestinal	5/54 (9.3%)		2/29 (6.9%)
Diarrhea Gastrointestinal	2/54 (3.7%)		2/29 (6.9%)
GI Hemorrhage/Bleeding	1/54 (1.9%)		0/29 (0%)
Nausea Gastrointestinal	1/54 (1.9%)		2/29 (6.9%)
Obstruction Gastrointestinal	0/54 (0%)		1/29 (3.4%)
Obstruction Bowel Gastrointestinal	7/54 (13%)		5/29 (17.2%)
Other- J tube Malfunction Gastrointestinal	1/54 (1.9%)		0/29 (0%)
Pain Gastrointestinal	0/54 (0%)		1/29 (3.4%)
Ulcer Jejunum Gastrointestinal	0/54 (0%)		1/29 (3.4%)
Ulcer: duod. Gastrointestinal	1/54 (1.9%)		0/29 (0%)
Vomiting Gastrointestinal	5/54 (9.3%)		0/29 (0%)
General disorders
Fatigue Constitutional Symptoms	1/54 (1.9%)		0/29 (0%)
Opioid Withdrawl Pain	1/54 (1.9%)		0/29 (0%)
Weight Loss Constitutional Symptoms	0/54 (0%)		1/29 (3.4%)
Immune system disorders
Penicillin Allergy/Immunology	1/54 (1.9%)		0/29 (0%)
Infections and infestations
Appendicitis Infection	1/54 (1.9%)		0/29 (0%)
Blood Infection	0/54 (0%)		1/29 (3.4%)
Catheter Infection	0/54 (0%)		1/29 (3.4%)
Cellulitis Infection	2/54 (3.7%)		1/29 (3.4%)
Fever Constitutional Symptoms	7/54 (13%)		3/29 (10.3%)
Kidney Infection	1/54 (1.9%)		0/29 (0%)
Perihepatic abscess Infection	0/54 (0%)		1/29 (3.4%)
Peritoneal Cavity Infection	1/54 (1.9%)		0/29 (0%)
Pneumonia Infection	1/54 (1.9%)		0/29 (0%)
Urinary Tract Infection	1/54 (1.9%)		0/29 (0%)
Wound Infection	4/54 (7.4%)		0/29 (0%)
Metabolism and nutrition disorders
AST Metabolic/Laboratory	1/54 (1.9%)		0/29 (0%)
Musculoskeletal and connective tissue disorders
Back Pain	0/54 (0%)		2/29 (6.9%)
Chest Wall Pain	0/54 (0%)		1/29 (3.4%)
Edema Limb Lymphatics	0/54 (0%)		1/29 (3.4%)
Fracture Musculoskeletal/Soft Tissue	1/54 (1.9%)		1/29 (3.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other- Maligancy Gastrointestinal	0/54 (0%)		1/29 (3.4%)
Nervous system disorders
Dizziness Neurology	0/54 (0%)		1/29 (3.4%)
Headache Pain	0/54 (0%)		1/29 (3.4%)
Syncope Neurology	1/54 (1.9%)		0/29 (0%)
Psychiatric disorders
Other-Suicide attempt	0/54 (0%)		1/29 (3.4%)
Respiratory, thoracic and mediastinal disorders
Pleural Effusion Pulmonary/ Upper Respiratory	2/54 (3.7%)		0/29 (0%)
Skin and subcutaneous tissue disorders
Wound complication Dermatology/Skin	1/54 (1.9%)		0/29 (0%)
Wound- Hernia Dermatology/Skin	2/54 (3.7%)		2/29 (6.9%)
Other (Not Including Serious) Adverse Events
	Sitagliptin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	54/54 (100%)		29/29 (100%)
Blood and lymphatic system disorders
Elevated WBC Blood/BoneMarrow	1/54 (1.9%)		1/29 (3.4%)
Hematoma Hemorrhage/Bleeding	1/54 (1.9%)		2/29 (6.9%)
Hemoglobin Blood/BoneMarrow	27/54 (50%)		13/29 (44.8%)
INR Coagulation	1/54 (1.9%)		0/29 (0%)
PTT Coagulation	1/54 (1.9%)		0/29 (0%)
Platelets Blood/BoneMarrow	0/54 (0%)		1/29 (3.4%)
Thrombosis Vascular	1/54 (1.9%)		3/29 (10.3%)
Cardiac disorders
Hypotension Caridac General	0/54 (0%)		1/29 (3.4%)
Ear and labyrinth disorders
Middle Ear Pain	1/54 (1.9%)		0/29 (0%)
Tinnitus Auditory/Ear	1/54 (1.9%)		0/29 (0%)
Endocrine disorders
Hot Flashes Endocrine	1/54 (1.9%)		0/29 (0%)
Hyperglycemia Endocrine	1/54 (1.9%)		0/29 (0%)
Hypoglycemia Metabolic/Laboratory	0/54 (0%)		1/29 (3.4%)
Hypothyroidism Endocrine	1/54 (1.9%)		0/29 (0%)
Irregular Menses Sexual/ Reproductive Function	0/54 (0%)		1/29 (3.4%)
Eye disorders
Blurred Vision Ocular/ Visual	1/54 (1.9%)		0/29 (0%)
Dry Eye Syndrome Ocular/ Visual	1/54 (1.9%)		0/29 (0%)
Other- Eye Swelling Allergy/Immunology	0/54 (0%)		1/29 (3.4%)
Other- eye redness/ lid swelling Ocular/ Visual	1/54 (1.9%)		0/29 (0%)
Photophobia Ocular/ Visual	1/54 (1.9%)		0/29 (0%)
Vision Blurred Vision Ocular/ Visual	1/54 (1.9%)		0/29 (0%)
Gastrointestinal disorders
Abdomen Pain	13/54 (24.1%)		9/29 (31%)
Anal Fissure Gastrointestinal	1/54 (1.9%)		0/29 (0%)
Anorexia Gastrointestinal	1/54 (1.9%)		1/29 (3.4%)
Ascites Gastrointestinal	5/54 (9.3%)		2/29 (6.9%)
Biliary Tree Leak Gastrointestinal	1/54 (1.9%)		0/29 (0%)
Colitis Gastrointestinal	1/54 (1.9%)		0/29 (0%)
Constipation Gastrointestinal	7/54 (13%)		3/29 (10.3%)
Dehydration Gastrointestinal	2/54 (3.7%)		1/29 (3.4%)
Diarrhea Gastrointestinal	17/54 (31.5%)		10/29 (34.5%)
Distention Gastrointestinal	0/54 (0%)		1/29 (3.4%)
Dry Mouth Gastrointestinal	1/54 (1.9%)		0/29 (0%)
GERD Gastrointestinal	1/54 (1.9%)		0/29 (0%)
GI Hemorrhage/Bleeding	2/54 (3.7%)		0/29 (0%)
Ileus Gastrointestinal	1/54 (1.9%)		0/29 (0%)
Liver Infection	0/54 (0%)		1/29 (3.4%)
Nausea Gastrointestinal	17/54 (31.5%)		6/29 (20.7%)
Other/ Temp Intol Constitutional Symptoms	1/54 (1.9%)		0/29 (0%)
Throat Pain	7/54 (13%)		2/29 (6.9%)
Tooth Pain	0/54 (0%)		1/29 (3.4%)
Vomiting Gastrointestinal	11/54 (20.4%)		7/29 (24.1%)
Vomitting Gastrointestinal	0/54 (0%)		1/29 (3.4%)
General disorders
Achy Constitutional Symptoms	1/54 (1.9%)		0/29 (0%)
Fatigue Constitutional Symptoms	6/54 (11.1%)		0/29 (0%)
Weight Gain Constitutional Symptoms	15/54 (27.8%)		4/29 (13.8%)
Weight Loss Constitutional Symptoms	25/54 (46.3%)		17/29 (58.6%)
Infections and infestations
Abdomen_infection Infection	0/54 (0%)		1/29 (3.4%)
Bladder Infection	1/54 (1.9%)		0/29 (0%)
Blood Infection	1/54 (1.9%)		0/29 (0%)
Bronchitis Infection	1/54 (1.9%)		1/29 (3.4%)
Catheter Infection	1/54 (1.9%)		0/29 (0%)
Cellulitis Infection	4/54 (7.4%)		1/29 (3.4%)
Dental- Tooth Infection	2/54 (3.7%)		1/29 (3.4%)
Fever Constitutional Symptoms	6/54 (11.1%)		7/29 (24.1%)
Flu-like syndrome Syndromes	8/54 (14.8%)		6/29 (20.7%)
Kidney Infection	2/54 (3.7%)		0/29 (0%)
Middle Ear Infection	1/54 (1.9%)		1/29 (3.4%)
Peritoneal Cavity Infection	1/54 (1.9%)		1/29 (3.4%)
Pharynx Infection	4/54 (7.4%)		0/29 (0%)
Pneumonia Infection	1/54 (1.9%)		2/29 (6.9%)
Shingles Infection	1/54 (1.9%)		0/29 (0%)
Sinus Infection	6/54 (11.1%)		2/29 (6.9%)
Toe Infection	1/54 (1.9%)		0/29 (0%)
Tonsilitis Infection	1/54 (1.9%)		0/29 (0%)
Upper Respiratory Infection	1/54 (1.9%)		0/29 (0%)
Urinary Tract Infection	7/54 (13%)		4/29 (13.8%)
Vagina Infection	1/54 (1.9%)		0/29 (0%)
Metabolism and nutrition disorders
ALT Metabolic/Laboratory	6/54 (11.1%)		4/29 (13.8%)
AST Metabolic/Laboratory	8/54 (14.8%)		3/29 (10.3%)
Albumin low Metabolic/Laboratory	25/54 (46.3%)		14/29 (48.3%)
Alk Phos high Metabolic/Laboratory	3/54 (5.6%)		0/29 (0%)
Alkalosis (metabolic) Metabolic/Laboratory	1/54 (1.9%)		0/29 (0%)
Creatinine Metabolic/Laboratory	0/54 (0%)		1/29 (3.4%)
Hyopalbuminemia Metabolic/Laboratory	0/54 (0%)		1/29 (3.4%)
Hypokalemia Metabolic/Laboratory	1/54 (1.9%)		0/29 (0%)
Triglyceride serum high Metabolic/Laboratory	0/54 (0%)		2/29 (6.9%)
Musculoskeletal and connective tissue disorders
Arthritis Musculoskeletal/Soft Tissue	1/54 (1.9%)		2/29 (6.9%)
Back Pain	5/54 (9.3%)		1/29 (3.4%)
Chest Wall Pain	0/54 (0%)		1/29 (3.4%)
Cyst Removal Musculoskeletal/Soft Tissue	1/54 (1.9%)		1/29 (3.4%)
Edema Limb Lymphatics	9/54 (16.7%)		4/29 (13.8%)
Extremity Pain	6/54 (11.1%)		3/29 (10.3%)
Fracture Musculoskeletal/Soft Tissue	0/54 (0%)		2/29 (6.9%)
Hip Pain	1/54 (1.9%)		1/29 (3.4%)
Joint Pain	1/54 (1.9%)		1/29 (3.4%)
Muscle Cramps Musculoskeletal/Soft Tissue	2/54 (3.7%)		1/29 (3.4%)
Muscle Spasm Musculoskeletal/Soft Tissue	1/54 (1.9%)		0/29 (0%)
Muscle Weakness Musculoskeletal/Soft Tissue	0/54 (0%)		1/29 (3.4%)
Musculoskeletal back Pain	0/54 (0%)		1/29 (3.4%)
Myalgia Pain	1/54 (1.9%)		1/29 (3.4%)
Myositis Musculoskeletal/Soft Tissue	0/54 (0%)		1/29 (3.4%)
Shoulder Pain	1/54 (1.9%)		0/29 (0%)
Weakness Musculoskeletal/Soft Tissue	0/54 (0%)		1/29 (3.4%)
Nervous system disorders
Concussion Neurology	0/54 (0%)		1/29 (3.4%)
Confusion Neurology	3/54 (5.6%)		0/29 (0%)
Depression Neurology	1/54 (1.9%)		1/29 (3.4%)
Dizziness Neurology	1/54 (1.9%)		2/29 (6.9%)
Headache Ocular/ Visual	1/54 (1.9%)		0/29 (0%)
Headache Pain	13/54 (24.1%)		7/29 (24.1%)
Insomnia Constitutional Symptoms	3/54 (5.6%)		0/29 (0%)
Memory Impairment Neurology	1/54 (1.9%)		0/29 (0%)
Neuropathy Sensory Neurology	0/54 (0%)		1/29 (3.4%)
Neuropathy/Sensory Neurology	1/54 (1.9%)		0/29 (0%)
Other-Meningioma Neurology	1/54 (1.9%)		0/29 (0%)
Seizure Neurology	1/54 (1.9%)		0/29 (0%)
Syncope Neurology	1/54 (1.9%)		0/29 (0%)
Psychiatric disorders
Anxiety Neurology	1/54 (1.9%)		1/29 (3.4%)
Mood Alteration-Panic attack	0/54 (0%)		1/29 (3.4%)
Mood Alteratons: Anxiety	2/54 (3.7%)		0/29 (0%)
Mood alteration other	1/54 (1.9%)		0/29 (0%)
Mood alteration-Depression	0/54 (0%)		1/29 (3.4%)
Psychosis Neurology	3/54 (5.6%)		1/29 (3.4%)
Renal and urinary disorders
Kidney Pain	1/54 (1.9%)		0/29 (0%)
Other- Kidney Stone Renal/ Genitourinary	2/54 (3.7%)		1/29 (3.4%)
Reproductive system and breast disorders
Libido Sexual/ Reproductive Function	1/54 (1.9%)		0/29 (0%)
Other- Ovarian cyst Sexual/ Reproductive Function	1/54 (1.9%)		0/29 (0%)
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis Allergy/Immunology	1/54 (1.9%)		0/29 (0%)
Bronchospasm Pulmonary/ Upper Respiratory	1/54 (1.9%)		0/29 (0%)
Chest/ Throat NOS Pain	1/54 (1.9%)		0/29 (0%)
Cough Pulmonary/ Upper Respiratory	8/54 (14.8%)		5/29 (17.2%)
Other-Congestion Pulmonary/ Upper Respiratory	1/54 (1.9%)		0/29 (0%)
Pulmonary/Upper Respiratory Infection	2/54 (3.7%)		0/29 (0%)
Rhinitis Allergy/Immunology	10/54 (18.5%)		4/29 (13.8%)
Voice Change Pulmonary/ Upper Respiratory	3/54 (5.6%)		1/29 (3.4%)
Skin and subcutaneous tissue disorders
Acne Dermatology/Skin	0/54 (0%)		1/29 (3.4%)
Rash Dermatology/Skin	4/54 (7.4%)		5/29 (17.2%)
Wound Infection	0/54 (0%)		1/29 (3.4%)
Wound complication Dermatology/Skin	1/54 (1.9%)		1/29 (3.4%)

Limitations/Caveats

It is also possible that the study is not powered enough to detect small differences in insulin independence. The feasibility of conducting any larger trial in the small population of adult islet autograft recipients is limited, however.

More Information

Certain Agreements

Principal Investigators are NOT 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.