Trial Outcomes & Findings for Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals (NCT NCT01862029)
NCT ID: NCT01862029
Last Updated: 2018-09-04
Results Overview
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.
COMPLETED
PHASE1/PHASE2
24 participants
Baseline
2018-09-04
Participant Flow
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.
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 Two additional subjects were withdrawn for new medical findings prior to their initiation of the study medication.
Participant milestones
| Measure |
Subjects Who Took Roflumilast
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.
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|---|---|
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Overall Study
STARTED
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9
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Overall Study
COMPLETED
|
8
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Overall Study
NOT COMPLETED
|
1
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Reasons for withdrawal
| Measure |
Subjects Who Took Roflumilast
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.
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|---|---|
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Overall Study
Physician Decision
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1
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Baseline Characteristics
Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals
Baseline characteristics by cohort
| Measure |
Roflumilast
n=9 Participants
Subjects with overweight/obesity and pre-diabetes who started Roflumilast, a phosphodiesterase 4 (PDE4) inhibitor.
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|---|---|
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Age, Continuous
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49.6 years
STANDARD_DEVIATION 6.4 • n=5 Participants
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Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
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Race/Ethnicity, Customized
Black or African-American
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6 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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2 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
Hispanic
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1 Participants
n=5 Participants
|
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Region of Enrollment
United States
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9 participants
n=5 Participants
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PRIMARY outcome
Timeframe: BaselinePopulation: Subjects who underwent the clamp procedure at time point: pre- roflumilast
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.
Outcome measures
| Measure |
Pre-roflumilast
n=7 Participants
Data before the subjects began taking roflumilast
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|---|---|
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Change in Insulin Sensitivity- Pre-roflumilast
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48.7 mg/grams Fat Free Mass/minute
Standard Error 10.4
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PRIMARY outcome
Timeframe: 6 weeksPopulation: Subjects who underwent the clamp procedure at time point: post-roflumilast
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.
Outcome measures
| Measure |
Pre-roflumilast
n=7 Participants
Data before the subjects began taking roflumilast
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|---|---|
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Change in Insulin Sensitivity - Post-roflumilast
|
70 mg/grams Fat Free Mass/minute
Standard Error 20.1
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Adverse Events
Subjects Who Took Roflumilast
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subjects Who Took Roflumilast
n=9 participants at risk
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.
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|---|---|
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Metabolism and nutrition disorders
Changes in appetite
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44.4%
4/9 • 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.
All events determined to be related to the study.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • 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.
All events determined to be related to the study.
|
|
Nervous system disorders
Headache
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44.4%
4/9 • 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.
All events determined to be related to the study.
|
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General disorders
Fatigue
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22.2%
2/9 • 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.
All events determined to be related to the study.
|
|
General disorders
Insomnia
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44.4%
4/9 • 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.
All events determined to be related to the study.
|
|
Gastrointestinal disorders
Diarrhea
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22.2%
2/9 • 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.
All events determined to be related to the study.
|
|
General disorders
Dizziness
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11.1%
1/9 • 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.
All events determined to be related to the study.
|
|
General disorders
Irritability
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22.2%
2/9 • 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.
All events determined to be related to the study.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
11.1%
1/9 • 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.
All events determined to be related to the study.
|
|
Nervous system disorders
Tremor
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11.1%
1/9 • 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.
All events determined to be related to the study.
|
|
Skin and subcutaneous tissue disorders
Pruritis
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11.1%
1/9 • 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.
All events determined to be related to the study.
|
|
Gastrointestinal disorders
Dyspepsia
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11.1%
1/9 • 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.
All events determined to be related to the study.
|
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Gastrointestinal disorders
Early satiety
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11.1%
1/9 • 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.
All events determined to be related to the study.
|
Additional Information
Jay H. Chung, Ph.D, MD
National Institute of Health, NHLBI, Laboratory of Obesity and Aging Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place