Trial Outcomes & Findings for Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant (NCT NCT01186562)
NCT ID: NCT01186562
Last Updated: 2017-05-31
Results Overview
percentage of patients insulin independent
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
83 participants
Primary outcome timeframe
12 months
Results posted on
2017-05-31
Participant Flow
Participant milestones
| Measure |
Sitagliptin
Sitagliptin: 100 mg PO daily
|
Placebo
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
29
|
|
Overall Study
COMPLETED
|
50
|
27
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant
Baseline characteristics by cohort
| Measure |
Sitagliptin
n=54 Participants
Sitagliptin: 100 mg PO daily
|
Placebo
n=29 Participants
Placebo: Placebo
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 11 • n=5 Participants
|
42.6 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
41 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
29 participants
n=7 Participants
|
83 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: N's reflect patients that returned for study follow up.
percentage of patients insulin independent
Outcome measures
| Measure |
Sitagliptin
n=50 Participants
Sitagliptin: 100 mg PO daily
|
Placebo
n=29 Participants
Placebo: Placebo
|
|---|---|---|
|
Insulin Independence
|
42 percentage of participants
|
45 percentage of participants
|
SECONDARY outcome
Timeframe: 18 monthspercentage of patients insulin independent
Outcome measures
| Measure |
Sitagliptin
n=50 Participants
Sitagliptin: 100 mg PO daily
|
Placebo
n=27 Participants
Placebo: Placebo
|
|---|---|---|
|
Insulin Independence
|
36 percentage of participants
|
44 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
AUC C-peptide obtained from a mixed meal test (measured time 0 to 2 hours after Boost HP)
Outcome measures
| Measure |
Sitagliptin
n=48 Participants
Sitagliptin: 100 mg PO daily
|
Placebo
n=27 Participants
Placebo: Placebo
|
|---|---|---|
|
Area Under the Curve (AUC) C-peptide (ng/dL*Min)
|
273 ng*min/dL
Standard Error 20
|
273 ng*min/dL
Standard Error 27
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: 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.
AUC C-peptide (ng/dL\*min) from mixed meal tolerance test (measured times 0 to 2 hours after Boost HP)
Outcome measures
| Measure |
Sitagliptin
n=44 Participants
Sitagliptin: 100 mg PO daily
|
Placebo
n=24 Participants
Placebo: Placebo
|
|---|---|---|
|
AUC C-peptide
|
274 min*ng/dL
Standard Deviation 20
|
235 min*ng/dL
Standard Deviation 27
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
Derived from intravenous gluocose tolerance testing (0 to 10 minute measures after dextrose bolus)
Outcome measures
| Measure |
Sitagliptin
n=49 Participants
Sitagliptin: 100 mg PO daily
|
Placebo
n=26 Participants
Placebo: Placebo
|
|---|---|---|
|
Acute C-peptide Response (ACR) to Glucose
|
9.9 min*ng/dL
Standard Error 1.2
|
7.2 min*ng/dL
Standard Error 1.6
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: 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.
Derived from intravenous glucose tolerance test (0 to 10 minute measures after IV dextrose bolus)
Outcome measures
| Measure |
Sitagliptin
n=46 Participants
Sitagliptin: 100 mg PO daily
|
Placebo
n=23 Participants
Placebo: Placebo
|
|---|---|---|
|
Acute C-peptide Response (ACR) to Glucose
|
6.9 min*ng/dL
Standard Error 1.0
|
6.0 min*ng/dL
Standard Error 1.4
|
Adverse Events
Sitagliptin
Serious events: 31 serious events
Other events: 54 other events
Deaths: 0 deaths
Placebo
Serious events: 26 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin
n=54 participants at risk
Sitagliptin: 100 mg PO daily
|
Placebo
n=29 participants at risk
Placebo: Placebo
|
|---|---|---|
|
Metabolism and nutrition disorders
AST Metabolic/Laboratory
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Abdomen Pain
|
14.8%
8/54 • 18 months
from treatment start to 18 month follow up
|
20.7%
6/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Appendicitis Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
6.9%
2/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Biliary Tree Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Blood Infection
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Catheter Infection
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Cellulitis Infection
|
3.7%
2/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Constipation Gastrointestinal
|
5.6%
3/54 • 18 months
from treatment start to 18 month follow up
|
10.3%
3/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Dehydration Gastrointestinal
|
9.3%
5/54 • 18 months
from treatment start to 18 month follow up
|
6.9%
2/29 • 18 months
from treatment start to 18 month follow up
|
|
Endocrine disorders
Diabetes Type 1 Endocrine
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Diarrhea Gastrointestinal
|
3.7%
2/54 • 18 months
from treatment start to 18 month follow up
|
6.9%
2/29 • 18 months
from treatment start to 18 month follow up
|
|
Nervous system disorders
Dizziness Neurology
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Edema Limb Lymphatics
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
General disorders
Fatigue Constitutional Symptoms
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Fever Constitutional Symptoms
|
13.0%
7/54 • 18 months
from treatment start to 18 month follow up
|
10.3%
3/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Fracture Musculoskeletal/Soft Tissue
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
GI Hemorrhage/Bleeding
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Nervous system disorders
Headache Pain
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Endocrine disorders
Hyperglycemia Metabolic/Laboratory
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Endocrine disorders
Hypoglycemia Metabolic/Laboratory
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
10.3%
3/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Kidney Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Nausea Gastrointestinal
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
6.9%
2/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Obstruction Gastrointestinal
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Obstruction Bowel Gastrointestinal
|
13.0%
7/54 • 18 months
from treatment start to 18 month follow up
|
17.2%
5/29 • 18 months
from treatment start to 18 month follow up
|
|
General disorders
Opioid Withdrawl Pain
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Other- J tube Malfunction Gastrointestinal
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other- Maligancy Gastrointestinal
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Psychiatric disorders
Other-Suicide attempt
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Pain Gastrointestinal
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Immune system disorders
Penicillin Allergy/Immunology
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Perihepatic abscess Infection
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Peritoneal Cavity Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion Pulmonary/ Upper Respiratory
|
3.7%
2/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Pneumonia Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Nervous system disorders
Syncope Neurology
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Blood and lymphatic system disorders
Thrombosis Vascular
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Ulcer Jejunum Gastrointestinal
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Ulcer: duod. Gastrointestinal
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Urinary Tract Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Vomiting Gastrointestinal
|
9.3%
5/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
General disorders
Weight Loss Constitutional Symptoms
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Wound Infection
|
7.4%
4/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Skin and subcutaneous tissue disorders
Wound complication Dermatology/Skin
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Skin and subcutaneous tissue disorders
Wound- Hernia Dermatology/Skin
|
3.7%
2/54 • 18 months
from treatment start to 18 month follow up
|
6.9%
2/29 • 18 months
from treatment start to 18 month follow up
|
Other adverse events
| Measure |
Sitagliptin
n=54 participants at risk
Sitagliptin: 100 mg PO daily
|
Placebo
n=29 participants at risk
Placebo: Placebo
|
|---|---|---|
|
Metabolism and nutrition disorders
ALT Metabolic/Laboratory
|
11.1%
6/54 • 18 months
from treatment start to 18 month follow up
|
13.8%
4/29 • 18 months
from treatment start to 18 month follow up
|
|
Metabolism and nutrition disorders
AST Metabolic/Laboratory
|
14.8%
8/54 • 18 months
from treatment start to 18 month follow up
|
10.3%
3/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Abdomen Pain
|
24.1%
13/54 • 18 months
from treatment start to 18 month follow up
|
31.0%
9/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Abdomen_infection Infection
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
General disorders
Achy Constitutional Symptoms
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Skin and subcutaneous tissue disorders
Acne Dermatology/Skin
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Metabolism and nutrition disorders
Albumin low Metabolic/Laboratory
|
46.3%
25/54 • 18 months
from treatment start to 18 month follow up
|
48.3%
14/29 • 18 months
from treatment start to 18 month follow up
|
|
Metabolism and nutrition disorders
Alk Phos high Metabolic/Laboratory
|
5.6%
3/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Metabolism and nutrition disorders
Alkalosis (metabolic) Metabolic/Laboratory
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis Allergy/Immunology
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Anal Fissure Gastrointestinal
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Anorexia Gastrointestinal
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Psychiatric disorders
Anxiety Neurology
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Arthritis Musculoskeletal/Soft Tissue
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
6.9%
2/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Ascites Gastrointestinal
|
9.3%
5/54 • 18 months
from treatment start to 18 month follow up
|
6.9%
2/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.3%
5/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Biliary Tree Leak Gastrointestinal
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Bladder Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Blood Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Eye disorders
Blurred Vision Ocular/ Visual
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Bronchitis Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm Pulmonary/ Upper Respiratory
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Catheter Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Cellulitis Infection
|
7.4%
4/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Chest/ Throat NOS Pain
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Colitis Gastrointestinal
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Nervous system disorders
Concussion Neurology
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Nervous system disorders
Confusion Neurology
|
5.6%
3/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Constipation Gastrointestinal
|
13.0%
7/54 • 18 months
from treatment start to 18 month follow up
|
10.3%
3/29 • 18 months
from treatment start to 18 month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Cough Pulmonary/ Upper Respiratory
|
14.8%
8/54 • 18 months
from treatment start to 18 month follow up
|
17.2%
5/29 • 18 months
from treatment start to 18 month follow up
|
|
Metabolism and nutrition disorders
Creatinine Metabolic/Laboratory
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Cyst Removal Musculoskeletal/Soft Tissue
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Dehydration Gastrointestinal
|
3.7%
2/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Dental- Tooth Infection
|
3.7%
2/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Nervous system disorders
Depression Neurology
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Diarrhea Gastrointestinal
|
31.5%
17/54 • 18 months
from treatment start to 18 month follow up
|
34.5%
10/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Distention Gastrointestinal
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Nervous system disorders
Dizziness Neurology
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
6.9%
2/29 • 18 months
from treatment start to 18 month follow up
|
|
Eye disorders
Dry Eye Syndrome Ocular/ Visual
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Dry Mouth Gastrointestinal
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Edema Limb Lymphatics
|
16.7%
9/54 • 18 months
from treatment start to 18 month follow up
|
13.8%
4/29 • 18 months
from treatment start to 18 month follow up
|
|
Blood and lymphatic system disorders
Elevated WBC Blood/BoneMarrow
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Extremity Pain
|
11.1%
6/54 • 18 months
from treatment start to 18 month follow up
|
10.3%
3/29 • 18 months
from treatment start to 18 month follow up
|
|
General disorders
Fatigue Constitutional Symptoms
|
11.1%
6/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Fever Constitutional Symptoms
|
11.1%
6/54 • 18 months
from treatment start to 18 month follow up
|
24.1%
7/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Flu-like syndrome Syndromes
|
14.8%
8/54 • 18 months
from treatment start to 18 month follow up
|
20.7%
6/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Fracture Musculoskeletal/Soft Tissue
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
6.9%
2/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
GERD Gastrointestinal
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
GI Hemorrhage/Bleeding
|
3.7%
2/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Nervous system disorders
Headache Ocular/ Visual
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Nervous system disorders
Headache Pain
|
24.1%
13/54 • 18 months
from treatment start to 18 month follow up
|
24.1%
7/29 • 18 months
from treatment start to 18 month follow up
|
|
Blood and lymphatic system disorders
Hematoma Hemorrhage/Bleeding
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
6.9%
2/29 • 18 months
from treatment start to 18 month follow up
|
|
Blood and lymphatic system disorders
Hemoglobin Blood/BoneMarrow
|
50.0%
27/54 • 18 months
from treatment start to 18 month follow up
|
44.8%
13/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Hip Pain
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Endocrine disorders
Hot Flashes Endocrine
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Metabolism and nutrition disorders
Hyopalbuminemia Metabolic/Laboratory
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Endocrine disorders
Hyperglycemia Endocrine
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Endocrine disorders
Hypoglycemia Metabolic/Laboratory
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Metabolism and nutrition disorders
Hypokalemia Metabolic/Laboratory
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Cardiac disorders
Hypotension Caridac General
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Endocrine disorders
Hypothyroidism Endocrine
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Blood and lymphatic system disorders
INR Coagulation
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Ileus Gastrointestinal
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Nervous system disorders
Insomnia Constitutional Symptoms
|
5.6%
3/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Endocrine disorders
Irregular Menses Sexual/ Reproductive Function
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Kidney Infection
|
3.7%
2/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Renal and urinary disorders
Kidney Pain
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Reproductive system and breast disorders
Libido Sexual/ Reproductive Function
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Liver Infection
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Nervous system disorders
Memory Impairment Neurology
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Middle Ear Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Ear and labyrinth disorders
Middle Ear Pain
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Psychiatric disorders
Mood Alteration-Panic attack
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Psychiatric disorders
Mood Alteratons: Anxiety
|
3.7%
2/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Psychiatric disorders
Mood alteration other
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Psychiatric disorders
Mood alteration-Depression
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps Musculoskeletal/Soft Tissue
|
3.7%
2/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasm Musculoskeletal/Soft Tissue
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Musculoskeletal/Soft Tissue
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal back Pain
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Myalgia Pain
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Myositis Musculoskeletal/Soft Tissue
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Nausea Gastrointestinal
|
31.5%
17/54 • 18 months
from treatment start to 18 month follow up
|
20.7%
6/29 • 18 months
from treatment start to 18 month follow up
|
|
Nervous system disorders
Neuropathy Sensory Neurology
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Nervous system disorders
Neuropathy/Sensory Neurology
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Eye disorders
Other- Eye Swelling Allergy/Immunology
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Renal and urinary disorders
Other- Kidney Stone Renal/ Genitourinary
|
3.7%
2/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Reproductive system and breast disorders
Other- Ovarian cyst Sexual/ Reproductive Function
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Eye disorders
Other- eye redness/ lid swelling Ocular/ Visual
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Other-Congestion Pulmonary/ Upper Respiratory
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Nervous system disorders
Other-Meningioma Neurology
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Other/ Temp Intol Constitutional Symptoms
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Blood and lymphatic system disorders
PTT Coagulation
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Peritoneal Cavity Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Pharynx Infection
|
7.4%
4/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Eye disorders
Photophobia Ocular/ Visual
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Blood and lymphatic system disorders
Platelets Blood/BoneMarrow
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Pneumonia Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
6.9%
2/29 • 18 months
from treatment start to 18 month follow up
|
|
Psychiatric disorders
Psychosis Neurology
|
5.6%
3/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory Infection
|
3.7%
2/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Skin and subcutaneous tissue disorders
Rash Dermatology/Skin
|
7.4%
4/54 • 18 months
from treatment start to 18 month follow up
|
17.2%
5/29 • 18 months
from treatment start to 18 month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergy/Immunology
|
18.5%
10/54 • 18 months
from treatment start to 18 month follow up
|
13.8%
4/29 • 18 months
from treatment start to 18 month follow up
|
|
Nervous system disorders
Seizure Neurology
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Shingles Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Sinus Infection
|
11.1%
6/54 • 18 months
from treatment start to 18 month follow up
|
6.9%
2/29 • 18 months
from treatment start to 18 month follow up
|
|
Nervous system disorders
Syncope Neurology
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Throat Pain
|
13.0%
7/54 • 18 months
from treatment start to 18 month follow up
|
6.9%
2/29 • 18 months
from treatment start to 18 month follow up
|
|
Blood and lymphatic system disorders
Thrombosis Vascular
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
10.3%
3/29 • 18 months
from treatment start to 18 month follow up
|
|
Ear and labyrinth disorders
Tinnitus Auditory/Ear
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Toe Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Tonsilitis Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Tooth Pain
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Metabolism and nutrition disorders
Triglyceride serum high Metabolic/Laboratory
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
6.9%
2/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Upper Respiratory Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Urinary Tract Infection
|
13.0%
7/54 • 18 months
from treatment start to 18 month follow up
|
13.8%
4/29 • 18 months
from treatment start to 18 month follow up
|
|
Infections and infestations
Vagina Infection
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Eye disorders
Vision Blurred Vision Ocular/ Visual
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
0.00%
0/29 • 18 months
from treatment start to 18 month follow up
|
|
Respiratory, thoracic and mediastinal disorders
Voice Change Pulmonary/ Upper Respiratory
|
5.6%
3/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Vomiting Gastrointestinal
|
20.4%
11/54 • 18 months
from treatment start to 18 month follow up
|
24.1%
7/29 • 18 months
from treatment start to 18 month follow up
|
|
Gastrointestinal disorders
Vomitting Gastrointestinal
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Musculoskeletal and connective tissue disorders
Weakness Musculoskeletal/Soft Tissue
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
General disorders
Weight Gain Constitutional Symptoms
|
27.8%
15/54 • 18 months
from treatment start to 18 month follow up
|
13.8%
4/29 • 18 months
from treatment start to 18 month follow up
|
|
General disorders
Weight Loss Constitutional Symptoms
|
46.3%
25/54 • 18 months
from treatment start to 18 month follow up
|
58.6%
17/29 • 18 months
from treatment start to 18 month follow up
|
|
Skin and subcutaneous tissue disorders
Wound Infection
|
0.00%
0/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
|
Skin and subcutaneous tissue disorders
Wound complication Dermatology/Skin
|
1.9%
1/54 • 18 months
from treatment start to 18 month follow up
|
3.4%
1/29 • 18 months
from treatment start to 18 month follow up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place