Trial Outcomes & Findings for Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis (NCT NCT00763412)
NCT ID: NCT00763412
Last Updated: 2017-06-05
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
2 year/end of study
Results posted on
2017-06-05
Participant Flow
Participant milestones
| Measure |
Placebo
1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
2. Repaglinide
repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Patients Who Received Repaglinide
n=4 Participants
All participants were receiving ADEK vitamins and pancreatic enzyme replacement. Patients were required to be clinically stable, without evidence of deterioration from previous pulmonary function tests (PFTs) for 3-months prior to the study and without CF exacerbation or hospitalization for 2-months prior to the study. Additionally, patients were required to have maintained stable weight within 5% variance for 3-months prior to participation. Exclusion criteria included fasting blood glucose levels \>126 mg/dL on study day, IV antibiotic or systemic steroid use within two months, oral corticosteroid usage for more than 28-days over the past 6-months, history of lung or liver transplant, elevated transaminases, allergic bronchopulmonary aspergillosis, or the inability to perform spirometry.
|
Total
n=8 Participants
Total of all reporting groups
|
Patients Who Received Placebo
n=4 Participants
All participants were receiving ADEK vitamins and pancreatic enzyme replacement. Patients were required to be clinically stable, without evidence of deterioration from previous pulmonary function tests (PFTs) for 3-months prior to the study and without CF exacerbation or hospitalization for 2-months prior to the study. Additionally, patients were required to have maintained stable weight within 5% variance for 3-months prior to participation. Exclusion criteria included fasting blood glucose levels \>126 mg/dL on study day, IV antibiotic or systemic steroid use within two months, oral corticosteroid usage for more than 28-days over the past 6-months, history of lung or liver transplant, elevated transaminases, allergic bronchopulmonary aspergillosis, or the inability to perform spirometry.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
15 years
n=7 Participants
|
15.5 years
n=5 Participants
|
16 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
8 participants
n=5 Participants
|
|
BMI
|
18.38 Kg/m^2
n=7 Participants
|
18.94 Kg/m^2
n=5 Participants
|
19.45 Kg/m^2
n=5 Participants
|
|
Wt Z score
|
-0.29 Z score
n=7 Participants
|
-0.7 Z score
n=5 Participants
|
-1.11 Z score
n=5 Participants
|
|
Fat %
|
22.06 % Fat mass
n=7 Participants
|
21.2 % Fat mass
n=5 Participants
|
20.34 % Fat mass
n=5 Participants
|
|
Lean %
|
75 % Lean mass
n=7 Participants
|
75.9 % Lean mass
n=5 Participants
|
76.71 % Lean mass
n=5 Participants
|
|
Tanner stage
|
3.25 units on a scale
n=7 Participants
|
3.5 units on a scale
n=5 Participants
|
3.75 units on a scale
n=5 Participants
|
|
FEV 1
|
92.75 % of lung function
n=7 Participants
|
95.25 % of lung function
n=5 Participants
|
97.75 % of lung function
n=5 Participants
|
|
Fasting Glucose
|
100 mg/dl
n=7 Participants
|
99.6 mg/dl
n=5 Participants
|
99.1 mg/dl
n=5 Participants
|
|
2 hour glucose
|
183 mg/dl
n=7 Participants
|
182.7 mg/dl
n=5 Participants
|
182.4 mg/dl
n=5 Participants
|
|
Fasting C-Peptide
|
1.7 mg/dl
n=7 Participants
|
1.45 mg/dl
n=5 Participants
|
1.2 mg/dl
n=5 Participants
|
|
2 hour c-peptide
|
9.5 mg/dl
n=7 Participants
|
9.6 mg/dl
n=5 Participants
|
9.7 mg/dl
n=5 Participants
|
|
Inflammatory marker
IL1
|
0.9 pg/ml
n=7 Participants
|
0.5 pg/ml
n=5 Participants
|
0.1 pg/ml
n=5 Participants
|
|
Inflammatory marker
IL6
|
12.6 pg/ml
n=7 Participants
|
10.5 pg/ml
n=5 Participants
|
8.3 pg/ml
n=5 Participants
|
|
Inflammatory marker
IL8
|
8.5 pg/ml
n=7 Participants
|
7.75 pg/ml
n=5 Participants
|
7 pg/ml
n=5 Participants
|
|
Inflammatory marker
TNF Alpha
|
4.5 pg/ml
n=7 Participants
|
5.9 pg/ml
n=5 Participants
|
7.3 pg/ml
n=5 Participants
|
|
CRP
|
2.1 mg/L
n=7 Participants
|
1.95 mg/L
n=5 Participants
|
1.8 mg/L
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 year/end of studyOutcome measures
| Measure |
1 Placebo
n=4 Participants
1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
2. Repaglinide
n=4 Participants
repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
|---|---|---|
|
BMI
|
19.63 Kg/m^2
Interval 15.56 to 22.64
|
21.19 Kg/m^2
Interval 20.78 to 21.8
|
PRIMARY outcome
Timeframe: 2 year/end of studyReporting % of Fat and Lean body mass
Outcome measures
| Measure |
1 Placebo
n=4 Participants
1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
2. Repaglinide
n=4 Participants
repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
|---|---|---|
|
Body Composition
Fat
|
19.82 % body mass
Interval 12.0 to 37.8
|
26.21 % body mass
Interval 8.78 to 34.26
|
|
Body Composition
Lean
|
77.15 % body mass
Interval 59.54 to 87.84
|
70.83 % body mass
Interval 62.82 to 87.8
|
PRIMARY outcome
Timeframe: 2 year/end of studyOutcome measures
| Measure |
1 Placebo
n=4 Participants
1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
2. Repaglinide
n=4 Participants
repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
|---|---|---|
|
CRP
|
9.6 mg/L
Interval 0.7 to 27.5
|
2 mg/L
Interval 0.6 to 3.7
|
SECONDARY outcome
Timeframe: 2-yearWe completed the OGTT at the 2 year/end of study visit.
Outcome measures
| Measure |
1 Placebo
n=4 Participants
1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
2. Repaglinide
n=4 Participants
repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
|---|---|---|
|
Glucose Tolerance
2 hour glucose
|
185.75 mg/dl
Interval 145.0 to 258.0
|
184 mg/dl
Interval 123.0 to 266.0
|
|
Glucose Tolerance
fasting glucose
|
101.5 mg/dl
Interval 91.0 to 121.0
|
94.5 mg/dl
Interval 85.0 to 108.0
|
SECONDARY outcome
Timeframe: 2 year/end of studyOutcome measures
| Measure |
1 Placebo
n=4 Participants
1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
2. Repaglinide
n=4 Participants
repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
|---|---|---|
|
Inflammatory Markers
IL1
|
0.14 pg/ml
Interval 0.13 to 0.17
|
0.34 pg/ml
Interval 0.13 to 1.0
|
|
Inflammatory Markers
IL6
|
10.4 pg/ml
Interval 0.54 to 28.6
|
6 pg/ml
Interval 2.2 to 11.9
|
|
Inflammatory Markers
IL8
|
5.8 pg/ml
Interval 3.59 to 10.79
|
5.2 pg/ml
Interval 3.1 to 8.33
|
|
Inflammatory Markers
TNF alpha
|
5.1 pg/ml
Interval 2.05 to 7.5
|
3.6 pg/ml
Interval 1.99 to 5.3
|
SECONDARY outcome
Timeframe: 2 year/end of studyOutcome measures
| Measure |
1 Placebo
n=4 Participants
1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
2. Repaglinide
n=4 Participants
repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
|---|---|---|
|
Wt Z Score
|
-1.21 Z score
Interval -1.94 to 0.08
|
-0.26 Z score
Interval -0.31 to 0.72
|
SECONDARY outcome
Timeframe: 2 year/end of studyPuberty scale measuring 1-5, 1 being least development, 5 being most development.
Outcome measures
| Measure |
1 Placebo
n=4 Participants
1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
2. Repaglinide
n=4 Participants
repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
|---|---|---|
|
Tanner Stage
|
4.25 units on a scale
Interval 4.0 to 5.0
|
5 units on a scale
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: 2 year/end of study% of lung function
Outcome measures
| Measure |
1 Placebo
n=4 Participants
1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
2. Repaglinide
n=4 Participants
repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
|---|---|---|
|
FEV 1
|
90.5 % lung function
Interval 71.0 to 99.0
|
91.5 % lung function
Interval 74.0 to 108.0
|
SECONDARY outcome
Timeframe: 2 yearOutcome measures
| Measure |
1 Placebo
n=4 Participants
1 pill before each meal 3-4 times a day for 2 years.
placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
2. Repaglinide
n=4 Participants
repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.
repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
|
|---|---|---|
|
C-Peptide
fasting
|
1.5 pg/ml
Interval 0.8 to 2.3
|
1.6 pg/ml
Interval 0.6 to 2.5
|
|
C-Peptide
2 hour
|
7.5 pg/ml
Interval 5.0 to 8.7
|
7.7 pg/ml
Interval 4.2 to 11.9
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Repaglinide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place