Could COPD drug help control blood sugar? new study explores
NCT ID NCT02363335
First seen Jun 26, 2026 · Last updated Jul 29, 2026 · Updated 4 times
Summary
This completed Phase 1 trial studied how two drugs, roflumilast (used for COPD) and sitagliptin (used for diabetes), affect blood sugar and gut hormones in 29 healthy volunteers aged 21-55. Participants received each drug alone, together, or a placebo, then drank a nutritional shake to measure hormone responses. The goal was to understand how these drugs might lower blood sugar, which could lead to new treatments for type 2 diabetes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Roflumilast and Sitagliptin
- What this could lead to
- If successful, this research could point toward new treatments for type 2 diabetes by better understanding how these drugs affect blood sugar and gut hormones.
- What could go wrong
- This is a small, early-phase study in healthy volunteers, not people with diabetes. The results may not apply to patients or lead to a new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
29 people
The number who actually took part.
- Start date
-
Feb 2015
- Finished
-
Sep 2016
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
21 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: 1. Age 21-55 (Age restriction is used to remove age as a confounding factor because (beta) cells function and insulin resistance tend to deteriorate with age and may affect GLP-1 and GIP levels. 2. Screening laboratory evaluations with no clinically significant abnormal results (minor deviations from normal lab results will be at the discretion of the principal investigator): 1. fasting comprehensive metabolic panel 2. complete blood count with differential and platelet 3. thyroid function test (TSH) 4. urine drug screen 5. Point of care urine pregnancy test (for women who are not surgically sterile) 3. BMI \< 30 (participants with BMI greater than or equal to 30 are excluded because obesity has been associated with attenuation in GLP-1 secretion. 4. Have had a history of stable weight (maintained weight within +/- 5%) over the past year 5. Have NOT participated in another clinical trial involving any pharmacologic agents within the past 30 days 6. Able to complete an inform consent 7. Agree to not participate in other clinical trials within the study period (at the discretion of the study investigator) EXCLUSION CRITERIA: 1. FPG greater than or equal to 100 mg/dl or 2-hr OGTT greater than or equal to 140 mg/dL (evidence of glucose intolerance or diabetes) 2. History of anemia, or Hemoglobin \< 12.5 mg/dL for men and \< 11.5 mg/dL for women during screening visit 3. Weight \< 110 pounds (due to blood volume requirement) 4. Evidence of illicit drug use 5. History of substance abuse including marijuana within the past 6 months 6. History of smoking any tobacco products within six months prior to screening 7. Alcohol intake \> 30 grams (drink more than 2 beers per day OR equivalent amount of alcohol) 8. History of Human Immunodeficiency Virus (HIV) infection 9. History of active or chronic Hepatitis B and/or C infection 10. History of psychiatric illnesses including major depressive disorder, schizophrenia, bipolar disorder 11. Any lifetime history of suicide attempt 12. History of any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the last year 13. Any suicidal ideation of type 4 or 5 on the C-SSRS during any follow-up visits. 14. Patient Health Questionnaire-9 (PHQ-9) score greater than or equal to 10 during screening visit or any follow-up study visits 15. Generalized Anxiety Disorder-7 (GAD-7) score greater than or equal to 10 during screening visit or any follow-up visits 16. History of pancreatitis 17. History of liver or renal diseases 18. History of gastrointestinal or endocrine disorders 19. History of malignancy (unless P.I. determines that there is no impact of the prior malignancy on study outcomes, i.e. basal cell skin cancer) 20. History of coronary disease or clinically significant abnormalities on electrocardiogram 21. History of seizures or other neurologic diseases 22. History of glucocorticoid use (over one month) or other immunosuppressive agents (any), i.e. Imuran, Neoral, Sandimmune, SangCya, basiliximab (Simulect), daclizumab (Zenapax), muromonab (Orthocolone OKT(3)) prednisone (Deltasone, Orasone) within the past six months 23. Use of proton pump inhibitors (PPI s), i.e. Prilosec, Prevacid, Achiphex, Protonix, Nexium, Zegarid 24. Women who are pregnant or nursing/breast-feeding a child 25. Any medical history that, in the opinion of the investigator(s), may make participation of the subject in the study unsafe
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224, United States
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