| Trial ID: | L2325 |
| Source ID: | NCT01936025
|
| Associated Drug: |
Dextromethorphan
|
| Title: |
A Study to Investigate the Glucose Lowering Effects of Dextromethorphan Alone or in Combination With Sitagliptin in Subjects With Type 2 Diabetes Mellitus (T2DM) After an Oral Glucose Tolerance Test
|
| Acronym: |
DXM2
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Dextromethorphan|DRUG: Sitagliptin|DRUG: Placebo
|
| Outcome Measures: |
Primary: lowest dose of DXM, To find the lowest dose of DXM that, compared to placebo, exerts BG lowering effects related to an OGTT, up to 4 hours after study drug administration | Secondary: additive BG lowering effects, To demonstrate whether the administration of DXM on top of sitagliptin exerts additive BG lowering effects related to an OGTT as compared to sitagliptin alone and DXM alone, up to 4 hours after study drug administration
|
| Sponsor/Collaborators: |
Sponsor: Profil Institut für Stoffwechselforschung GmbH
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
34
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-10
|
| Completion Date: |
2014-04
|
| Results First Posted: |
|
| Last Update Posted: |
2017-11-07
|
| Locations: |
Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01936025
|
