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Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals

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ClinicalTrials.gov Identifier: NCT01862029
Recruitment Status : Completed
First Posted : May 24, 2013
Results First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Obesity
Intervention Drug: Roflumilast
Enrollment 24
Recruitment Details Subjects who passed the telephone screening were invited to undergo further screening in the clinic. A total of 24 subjects were subsequently screened. Among these subjects, 14 subjects met the study's inclusion criteria.
Pre-assignment Details Among the 14 subjects who met the inclusion criteria, 3 subjects withdrew participation prior to starting the study procedures due to expected possibility of noncompliance with the protocol schedule. Two additional subjects were withdrawn for new medical findings prior to their initiation of the study medication.
Arm/Group Title Subjects Who Took Roflumilast
Hide Arm/Group Description Subjects with overweight/obesity and pre-diabetes were to take Roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, for a total of six weeks. They were to take roflumilast 250mcg daily for the first two weeks and then, 500mcg daily for the remaining four weeks.
Period Title: Overall Study
Started 9
Completed 8
Not Completed 1
Reason Not Completed
Physician Decision             1
Arm/Group Title Roflumilast
Hide Arm/Group Description Subjects with overweight/obesity and pre-diabetes who started Roflumilast, a phosphodiesterase 4 (PDE4) inhibitor.
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
49.6  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
3
  33.3%
Male
6
  66.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Black or African-American
6
  66.7%
White
2
  22.2%
Hispanic
1
  11.1%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
[1]
Measure Description: Subjects resided either within District of Columbia or within the states of Maryland or Virginia.
1.Primary Outcome
Title Change in Insulin Sensitivity- Pre-roflumilast
Hide Description Our primary outcome measure is the change in peripheral insulin sensitivity. The hyperinsulinemic euglycemic clamp procedure's M value, which was obtained before the subjects began roflumilast, was used to assess the primary outcome.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who underwent the clamp procedure at time point: pre- roflumilast
Arm/Group Title Pre-roflumilast
Hide Arm/Group Description:
Data before the subjects began taking roflumilast
Overall Number of Participants Analyzed 7
Mean (Standard Error)
Unit of Measure: mg/grams Fat Free Mass/minute
48.7  (10.4)
2.Primary Outcome
Title Change in Insulin Sensitivity - Post-roflumilast
Hide Description Our primary outcome measure is the change in peripheral insulin sensitivity. The hyperinsulinemic euglycemic clamp procedure's M value, which was obtained post-roflumilast, was used for this primary outcome assessment.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who underwent the clamp procedure at time point: post-roflumilast
Arm/Group Title Post-roflumilast
Hide Arm/Group Description:
Data obtained after subjects took roflumilast for a total of six weeks
Overall Number of Participants Analyzed 7
Mean (Standard Error)
Unit of Measure: mg/grams Fat Free Mass/minute
70  (20.1)
Time Frame Adverse events data was collected in the seven weeks time period of the study calendar. Six of these weeks were while the subjects were on roflumilast and one week was after the subject discontinued roflumilast.
Adverse Event Reporting Description All events determined to be related to the study.
 
Arm/Group Title Subjects Who Took Roflumilast
Hide Arm/Group Description Subjects with overweight/obesity and pre-diabetes were assigned to take Roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, for a total of six weeks as follows: 250mcg daily for the first two weeks and then, 500mcg daily for the remaining four weeks.
All-Cause Mortality
Subjects Who Took Roflumilast
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Subjects Who Took Roflumilast
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Subjects Who Took Roflumilast
Affected / at Risk (%)
Total   6/9 (66.67%) 
Gastrointestinal disorders   
Nausea   1/9 (11.11%) 
Diarrhea   2/9 (22.22%) 
Dyspepsia   1/9 (11.11%) 
Early satiety *  1/9 (11.11%) 
General disorders   
Fatigue   2/9 (22.22%) 
Insomnia   4/9 (44.44%) 
Dizziness   1/9 (11.11%) 
Irritability   2/9 (22.22%) 
Metabolism and nutrition disorders   
Changes in appetite  [1]  4/9 (44.44%) 
Musculoskeletal and connective tissue disorders   
Neck Pain   1/9 (11.11%) 
Nervous system disorders   
Headache   4/9 (44.44%) 
Tremor   1/9 (11.11%) 
Skin and subcutaneous tissue disorders   
Pruritis   1/9 (11.11%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Increased or decreased appetite
The sample size for the assessment of the primary outcome was less than planned.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jay H. Chung, Ph.D, MD
Organization: National Institute of Health, NHLBI, Laboratory of Obesity and Aging Research
Phone: 301-496-3075
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT01862029     History of Changes
Other Study ID Numbers: 130123
13-H-0123
First Submitted: May 22, 2013
First Posted: May 24, 2013
Results First Submitted: July 26, 2018
Results First Posted: September 3, 2018
Last Update Posted: September 3, 2018