| Trial ID: | L5201 |
| Source ID: | NCT03359590
|
| Associated Drug: |
Sitagliptin 100 Mg
|
| Title: |
Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03359590/results
|
| Conditions: |
Pharmacological Action
|
| Interventions: |
DRUG: Sitagliptin 100 mg|DRUG: Placebo
|
| Outcome Measures: |
Primary: The Frequency of Hypoglycaemic Episodes With Sitagliptin vs Placebo Treatment., The purpose of the trial was to test the influence of DPP-4 inhibition on the risk to develop hypoglycaemia. Chemical hypoglycaemic episodes (characterised by a plasma glucose nadir ≤70 mg/dL) occurring during the in-house periods of the subjects were compared., during the two in-house periods (54 hs each) after treatment with sitagliptin or placebo for up to 24 weeks |
|
| Sponsor/Collaborators: |
Sponsor: Profil Institut für Stoffwechselforschung GmbH | Collaborators: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-03-21
|
| Completion Date: |
2019-07-17
|
| Results First Posted: |
2021-02-21
|
| Last Update Posted: |
2021-02-21
|
| Locations: |
Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT03359590
|
