| Trial ID: | L4243 |
| Source ID: | NCT05161741
|
| Associated Drug: |
Insulin
|
| Title: |
Research on Human Insulin rDNA Safety and Efficacy in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
RISE
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Adverse Drug Event|Effect of Drug|Type 2 Diabetes Treated With Insulin
|
| Interventions: |
DRUG: Insulin
|
| Outcome Measures: |
Primary: Frequency of adverse events, serious adverse events during the course of study follow-up, Drug safety, 6 months|Change from baseline in HbA1c% to the last-observation, Drug efficacy, 6 months|Change from baseline in fasting plasma glucose to the last- observation on treatment, Drug efficacy, 6 months |
|
| Sponsor/Collaborators: |
Sponsor: Getz Pharma
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
238
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-01-01
|
| Completion Date: |
2022-11-30
|
| Results First Posted: |
|
| Last Update Posted: |
2023-02-06
|
| Locations: |
Social Security Hospital, Lahore, Punjab, 54500, Pakistan
|
| URL: |
https://clinicaltrials.gov/show/NCT05161741
|
