| Trial ID: | L3585 |
| Source ID: | NCT06619301
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
RCT Glargine vs NPH for Treatment of DM in Pregnancy
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus in Pregnancy|Type 2 Diabetes Mellitus (T2DM)|Gestational Diabetes Mellitus, Class A2
|
| Interventions: |
DRUG: Insulin glargine|DRUG: insulin NPH
|
| Outcome Measures: |
Primary: Hypoglycemia, Episodes of hypoglycemia with blood glucose less than 60 mg/dL, From initiation of insulin therapy to delivery | Secondary: Large for Gestational Age, Birth weight greater than or equal to the 90th percentile for gestational age, At delivery|Shoulder dystocia, Diagnosed by delivering providing, At delivery
|
| Sponsor/Collaborators: |
Sponsor: Loyola University
|
| Gender: |
FEMALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
160
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-04-01
|
| Completion Date: |
2027-01-01
|
| Results First Posted: |
|
| Last Update Posted: |
2024-10-01
|
| Locations: |
Loyola University Medical Center, Maywood, Illinois, 60153, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT06619301
|
