| Trial ID: | L3886 |
| Source ID: | NCT02607410
|
| Associated Drug: |
Sitagliptin
|
| Title: |
Sitagliptin (DPP-4 Inhibitor) and NPH Insulin in Patients With T2D
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: sitagliptin|DRUG: NPH insulin
|
| Outcome Measures: |
Primary: improvement in HbA1c levels, Changes in fasting blood levels of HBA1c (%), six and twelve months | Secondary: improvement of beta cell function with a meal test, Changes in serum C-peptide levels (ng/mL), six and twelve months after each therapy at times zero, 30, 60, 120 and 180 minutes after meal test|improvement on alpha cell function with a meal test, Changes in plasma glucagon levels (pg/mL), six and twelve months after each therapy at times zero, 30, 60, 120 and 180 minutes after meal test
|
| Sponsor/Collaborators: |
Sponsor: University of Sao Paulo General Hospital | Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-01
|
| Completion Date: |
2014-07
|
| Results First Posted: |
|
| Last Update Posted: |
2015-11-18
|
| Locations: |
University of Sao Paulo General Hospital, Sao Paulo, 05403-000, Brazil
|
| URL: |
https://clinicaltrials.gov/show/NCT02607410
|
