| Trial ID: | L5934 |
| Source ID: | NCT05167513
|
| Associated Drug: |
Metformin / Sitagliptin Oral Tablet
|
| Title: |
Monitoring Parameters Beyond Glycemic Control: Impact of Sitagliptin on Quality of Life in Type 2 Diabetes Patients
|
| Acronym: |
DQOL
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Quality of Life|Type 2 Diabetes|Metformin+Sitagliptin
|
| Interventions: |
DRUG: Metformin / Sitagliptin Oral Tablet
|
| Outcome Measures: |
Primary: Diabetes Quality of Life assessment using DQOL-13 questionnaire, Satisfaction (6 questions) Impact (4 questions) Worry (3 questions) Scoring from 1 to 5 for worst to best quality at each question (low score means poor quality) Assessment at enrollment and follow ups (at 1st, 3rd and 6th months), 6 months | Secondary: Frequency of adverse events and serious adverse events during the course of study follow-up, 6 months|Change from baseline in HbA1c % and fasting blood sugar FBS (mg/dl) to the last-observation on treatment, 6 months
|
| Sponsor/Collaborators: |
Sponsor: Getz Pharma
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
188
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-01-01
|
| Completion Date: |
2022-04-28
|
| Results First Posted: |
|
| Last Update Posted: |
2022-05-04
|
| Locations: |
Primary Care Diabetes Association, Karachi, Sindh, 75330, Pakistan
|
| URL: |
https://clinicaltrials.gov/show/NCT05167513
|