Trial Outcomes & Findings for Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes (NCT NCT01927562)
NCT ID: NCT01927562
Last Updated: 2024-02-14
Results Overview
Improvement in fasting plasma glucose based on Mixed Meal Tolerance Test between baseline and 3 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
3 months
Results posted on
2024-02-14
Participant Flow
A screening endoscopy is performed to visually examine the participant's GI tract to ensure they meet the requirements of the exclusion criteria concerning anatomical anomalies that would preclude the ability to complete the treatment. A biopsy is also taken to evaluate the baseline tissue.
Participant milestones
| Measure |
Duodenal Treatment
Fractyl Duodenal Remodeling System
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
38
|
Reasons for withdrawal
| Measure |
Duodenal Treatment
Fractyl Duodenal Remodeling System
|
|---|---|
|
Overall Study
Lost to Follow-up
|
30
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Physician Decision
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Duodenal Treatment
n=57 Participants
Fractyl Duodenal Remodeling System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=57 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=57 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=57 Participants
|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 8.3 • n=57 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=57 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=57 Participants
|
|
Region of Enrollment
Chile
|
57 Participants
n=57 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: The 5 subjects who did not receive an ablation were excluded from the efficacy population, yielding 52 subjects in the efficacy population (as-treated population).
Improvement in fasting plasma glucose based on Mixed Meal Tolerance Test between baseline and 3 months
Outcome measures
| Measure |
Duodenal Treatment
n=52 Participants
Fractyl Duodenal Remodeling System
|
|---|---|
|
Changed in Mixed Meal Tolerance From Baseline to 3 Months
FPG with MMTT at 3 months
|
145.3 mg/dL
Standard Deviation 53.7
|
|
Changed in Mixed Meal Tolerance From Baseline to 3 Months
FPG with MMTT at Baseline
|
180.9 mg/dL
Standard Deviation 53.9
|
Adverse Events
Duodenal Treatment
Serious events: 3 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Duodenal Treatment
n=57 participants at risk
Fractyl Duodenal Remodeling System
|
|---|---|
|
Injury, poisoning and procedural complications
procedural complication
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
duodenal stenosis
|
5.3%
3/57 • Number of events 3 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Cancer
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Skin and subcutaneous tissue disorders
skin ulcer
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
Other adverse events
| Measure |
Duodenal Treatment
n=57 participants at risk
Fractyl Duodenal Remodeling System
|
|---|---|
|
Gastrointestinal disorders
abdominal distension
|
19.3%
11/57 • Number of events 12 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
abdominal pain
|
17.5%
10/57 • Number of events 11 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
Diarrhoea
|
14.0%
8/57 • Number of events 8 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.3%
7/57 • Number of events 7 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
Change of bowel habit
|
7.0%
4/57 • Number of events 4 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
dyspepsia
|
7.0%
4/57 • Number of events 4 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
duodenal stenosis
|
5.3%
3/57 • Number of events 3 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
duodenitis
|
5.3%
3/57 • Number of events 3 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
constipation
|
3.5%
2/57 • Number of events 2 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
gastritis erosive
|
3.5%
2/57 • Number of events 2 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
oesophagitis
|
3.5%
2/57 • Number of events 2 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
vomiting
|
3.5%
2/57 • Number of events 2 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
abdominal discomfort
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
abdominal pain lower
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
dental caries
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
dental discomfort
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
flatulence
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
gastric ulcer
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
gingival oedema
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
irritable bowel syndrome
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
oesophageal ulcer
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Gastrointestinal disorders
regurgitation
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Metabolism and nutrition disorders
polydipsia
|
15.8%
9/57 • Number of events 11 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
5.3%
3/57 • Number of events 3 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
3.5%
2/57 • Number of events 2 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Metabolism and nutrition disorders
gout
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
7.0%
4/57 • Number of events 4 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Musculoskeletal and connective tissue disorders
back pain
|
7.0%
4/57 • Number of events 4 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
5.3%
3/57 • Number of events 3 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
3.5%
2/57 • Number of events 2 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Musculoskeletal and connective tissue disorders
rotator cuff syndrome
|
3.5%
2/57 • Number of events 2 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Infections and infestations
nasopharyngitis
|
7.0%
4/57 • Number of events 4 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Infections and infestations
genital candidiasis
|
5.3%
3/57 • Number of events 3 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Infections and infestations
candida infection
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Infections and infestations
gastroenteritis viral
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Infections and infestations
influenza
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Infections and infestations
rash pustular
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Infections and infestations
tooth abcess
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Infections and infestations
tooth infection
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Infections and infestations
vulvovaginitis
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Psychiatric disorders
depressed mood
|
5.3%
3/57 • Number of events 3 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Psychiatric disorders
depression
|
5.3%
3/57 • Number of events 3 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Psychiatric disorders
anxiety
|
3.5%
2/57 • Number of events 2 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Psychiatric disorders
stress
|
3.5%
2/57 • Number of events 2 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Psychiatric disorders
emotional distress
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Psychiatric disorders
insomnia
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Psychiatric disorders
panic attack
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Renal and urinary disorders
polyuria
|
15.8%
9/57 • Number of events 10 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Renal and urinary disorders
renal colic
|
3.5%
2/57 • Number of events 2 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Renal and urinary disorders
nocturia
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
3.5%
2/57 • Number of events 2 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Injury, poisoning and procedural complications
contusion
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Injury, poisoning and procedural complications
fall
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Injury, poisoning and procedural complications
humerus fracture
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Injury, poisoning and procedural complications
laceration
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Injury, poisoning and procedural complications
meniscus injury
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Injury, poisoning and procedural complications
procedural headache
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Injury, poisoning and procedural complications
procedural hypertension
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Injury, poisoning and procedural complications
skin injury
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Nervous system disorders
headache
|
3.5%
2/57 • Number of events 2 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Nervous system disorders
paraesthesia
|
3.5%
2/57 • Number of events 2 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Nervous system disorders
ageusia
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Nervous system disorders
facial paresis
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Nervous system disorders
neuropathy peripheral
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Nervous system disorders
sensory loss
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
12.3%
7/57 • Number of events 7 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Eye disorders
visual acuity reduced
|
5.3%
3/57 • Number of events 3 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Eye disorders
vision blurred
|
3.5%
2/57 • Number of events 2 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Eye disorders
retinopathy
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Skin and subcutaneous tissue disorders
Acanthosis
|
3.5%
2/57 • Number of events 2 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
General disorders
Gait disturbance
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
General disorders
Peripheral swelling
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
General disorders
Pyrexia
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
acrochordon
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
hepatic cancer
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate cancer
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Endocrine disorders
hypothyroidism
|
3.5%
2/57 • Number of events 2 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Blood and lymphatic system disorders
lymphadenopathy
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Cardiac disorders
angina pectoris
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Hepatobiliary disorders
jaundice
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
|
Investigations
heart rate decreased
|
1.8%
1/57 • Number of events 1 • Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All information received by PRINCIPAL INVESTIGATOR from SPONSOR, including, but not limited to, the Protocol, and all information developed during the Study is confidential information ("Confidential Information"), which is the sole and exclusive property of SPONSOR during the period of this Agreement and subsequent thereto.
- Publication restrictions are in place
Restriction type: OTHER