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Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT00763412
Recruitment Status : Completed
First Posted : October 1, 2008
Results First Posted : June 5, 2017
Last Update Posted : June 5, 2017
Sponsor:
Collaborators:
Washington University School of Medicine
National Institutes of Health (NIH)
Novo Nordisk A/S
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ana Maria Arbelaez, Arbelaez, Ana Maria

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Conditions Cystic Fibrosis Related Diabetes
Pancreatic Insufficiency
Interventions Drug: placebo
Drug: repaglinide
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo 2. Repaglinide
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 8 8
Completed 4 4
Not Completed 4 4
Arm/Group Title Patients Who Received Placebo Patients Who Received Repaglinide Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 4 4 8
Hide Baseline Analysis Population Description
Patients attended the Washington University CF Clinics between 2006 and 2008.
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
<=18 years
3
  75.0%
3
  75.0%
6
  75.0%
Between 18 and 65 years
1
  25.0%
1
  25.0%
2
  25.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Patients attended the Washington University CF Clinics between 2006 and 2008.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 8 participants
16
(12 to 18)
15
(12 to 22)
15.5
(12 to 22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
Female
2
  50.0%
3
  75.0%
5
  62.5%
Male
2
  50.0%
1
  25.0%
3
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 4 participants 8 participants
8 8 16
BMI  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 4 participants 4 participants 8 participants
19.45
(14.55 to 22.96)
18.38
(16.78 to 20.3)
18.94
(14.55 to 22.96)
Wt Z score  
Mean (Full Range)
Unit of measure:  Z score
Number Analyzed 4 participants 4 participants 8 participants
-1.11
(-1.84 to 0.33)
-0.29
(-0.75 to 0.19)
-0.7
(-1.84 to .33)
Fat %  
Mean (Full Range)
Unit of measure:  % Fat mass
Number Analyzed 4 participants 4 participants 8 participants
20.34
(7.36 to 38.74)
22.06
(9.76 to 28.81)
21.2
(7.36 to 38.74)
Lean %  
Mean (Full Range)
Unit of measure:  % Lean mass
Number Analyzed 4 participants 4 participants 8 participants
76.71
(58.6 to 89.67)
75
(68.22 to 87.11)
75.9
(58.6 to 89.67)
Tanner stage   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 4 participants 4 participants 8 participants
3.75
(2 to 5)
3.25
(1 to 5)
3.5
(1 to 5)
[1]
Measure Description: This is a measurement of puberty development. This is a 1-5 scale describing 1 as the least developed and 5 as the most developed in puberty.
FEV 1  
Mean (Full Range)
Unit of measure:  % of lung function
Number Analyzed 4 participants 4 participants 8 participants
97.75
(92 to 121)
92.75
(70 to 105)
95.25
(70 to 121)
Fasting Glucose   [1] 
Mean (Full Range)
Unit of measure:  Mg/dl
Number Analyzed 4 participants 4 participants 8 participants
99.1
(87 to 114.5)
100
(94 to 106)
99.6
(87 to 114.5)
[1]
Measure Description: This was the baseline glucose in a 2 hour oral glucose tolerance test. (OGTT)
2 hour glucose   [1] 
Mean (Full Range)
Unit of measure:  Mg/dl
Number Analyzed 4 participants 4 participants 8 participants
182.4
(144 to 218.5)
183
(140 to 206)
182.7
(140 to 218.5)
[1]
Measure Description: Final glucose sample in a 2 hour OGTT.
Fasting C-Peptide  
Mean (Full Range)
Unit of measure:  Mg/dl
Number Analyzed 4 participants 4 participants 8 participants
1.2
(0.6 to 2.1)
1.7
(1.0 to 3)
1.45
(0.6 to 3)
2 hour c-peptide   [1] 
Mean (Full Range)
Unit of measure:  Mg/dl
Number Analyzed 4 participants 4 participants 8 participants
9.7
(6 to 15.5)
9.5
(5 to 12.6)
9.6
(5 to 15.5)
[1]
Measure Description: final c-peptide measurement at the end of 2 hour OGTT.
Inflammatory marker   [1] 
Mean (Full Range)
Unit of measure:  Pg/ml
Number Analyzed 4 participants 4 participants 8 participants
IL1
0.1
(0.1 to 1.9)
0.9
(.01 to 1.7)
0.5
(0.1 to 1.9)
IL6
8.3
(1.5 to 26.4)
12.6
(3.7 to 33.8)
10.5
(1.5 to 33.8)
IL8
7
(2.7 to 17.8)
8.5
(4.6 to 13.6)
7.75
(2.7 to 17.8)
TNF Alpha
7.3
(5.2 to 7.3)
4.5
(2.5 to 6.4)
5.9
(2.5 to 7.3)
[1]
Measure Description: baseline values collected during a 2 hour OGTT.
CRP   [1] 
Mean (Full Range)
Unit of measure:  mg/L
Number Analyzed 4 participants 4 participants 8 participants
1.8
(0.2 to 2.5)
2.1
(0.8 to 3.3)
1.95
(0.2 to 3.3)
[1]
Measure Description: inflammatory marker
1.Primary Outcome
Title BMI
Hide Description [Not Specified]
Time Frame 2 year/end of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Placebo 2. Repaglinide
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 4 4
Mean (Full Range)
Unit of Measure: Kg/m^2
19.63
(15.56 to 22.64)
21.19
(20.78 to 21.8)
2.Primary Outcome
Title Body Composition
Hide Description Reporting % of Fat and Lean body mass
Time Frame 2 year/end of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Placebo 2. Repaglinide
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 4 4
Mean (Full Range)
Unit of Measure: % body mass
Fat
19.82
(12 to 37.8)
26.21
(8.78 to 34.26)
Lean
77.15
(59.54 to 87.84)
70.83
(62.82 to 87.8)
3.Primary Outcome
Title CRP
Hide Description [Not Specified]
Time Frame 2 year/end of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Placebo 2. Repaglinide
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 4 4
Mean (Full Range)
Unit of Measure: mg/L
9.6
(0.7 to 27.5)
2
(0.6 to 3.7)
4.Secondary Outcome
Title Glucose Tolerance
Hide Description We completed the OGTT at the 2 year/end of study visit.
Time Frame 2-year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Placebo 2. Repaglinide
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 4 4
Mean (Full Range)
Unit of Measure: mg/dl
fasting glucose
101.5
(91 to 121)
94.5
(85 to 108)
2 hour glucose
185.75
(145 to 258)
184
(123 to 266)
5.Secondary Outcome
Title Inflammatory Markers
Hide Description [Not Specified]
Time Frame 2 year/end of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Placebo 2. Repaglinide
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 4 4
Mean (Full Range)
Unit of Measure: pg/ml
IL1
0.14
(0.13 to 0.17)
0.34
(0.13 to 1)
IL6
10.4
(0.54 to 28.6)
6
(2.2 to 11.9)
IL8
5.8
(3.59 to 10.79)
5.2
(3.1 to 8.33)
TNF alpha
5.1
(2.05 to 7.5)
3.6
(1.99 to 5.3)
6.Secondary Outcome
Title Wt Z Score
Hide Description [Not Specified]
Time Frame 2 year/end of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Placebo 2. Repaglinide
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 4 4
Mean (Full Range)
Unit of Measure: Z score
-1.21
(-1.94 to 0.08)
-0.26
(-0.31 to 0.72)
7.Secondary Outcome
Title Tanner Stage
Hide Description Puberty scale measuring 1-5, 1 being least development, 5 being most development.
Time Frame 2 year/end of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Placebo 2. Repaglinide
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 4 4
Mean (Full Range)
Unit of Measure: units on a scale
4.25
(4 to 5)
5
(5 to 5)
8.Secondary Outcome
Title FEV 1
Hide Description % of lung function
Time Frame 2 year/end of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Placebo 2. Repaglinide
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 4 4
Mean (Full Range)
Unit of Measure: % lung function
90.5
(71 to 99)
91.5
(74 to 108)
9.Secondary Outcome
Title C-Peptide
Hide Description [Not Specified]
Time Frame 2 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Placebo 2. Repaglinide
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 4 4
Mean (Full Range)
Unit of Measure: pg/ml
fasting
1.5
(0.8 to 2.3)
1.6
(0.6 to 2.5)
2 hour
7.5
(5 to 8.7)
7.7
(4.2 to 11.9)
Time Frame This pilot study was designed to collect data over a 2 year time period.
Adverse Event Reporting Description Glucose diaries, and food diaries were reviewed, and safety labs were collected at each visit. Physical assessments by the PI were completed as well.
 
Arm/Group Title Placebo Repaglinide
Hide Arm/Group Description Placebo group of CF pancreatic insufficient patients ages 12-24 years old with impaired glucose tolerance test (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH). Repaglinide intervention group of CF pancreatic insufficient patients ages 12-24 years old with impaired glucose tolerance test (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH).
All-Cause Mortality
Placebo Repaglinide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Hide Serious Adverse Events
Placebo Repaglinide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Repaglinide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
A limitation of the study was the very small sample size.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ana Maria Arbelaez
Organization: Washington University in St Louis
Phone: 314-286-1138
EMail: arbelaez_a@kids.wustl.edu
Layout table for additonal information
Responsible Party: Ana Maria Arbelaez, Arbelaez, Ana Maria
ClinicalTrials.gov Identifier: NCT00763412    
Other Study ID Numbers: 05-1109
P60DK020579 ( U.S. NIH Grant/Contract )
First Submitted: September 29, 2008
First Posted: October 1, 2008
Results First Submitted: July 11, 2016
Results First Posted: June 5, 2017
Last Update Posted: June 5, 2017