Phase 4
Completed N=40
Humalog® Mix50/50(tm) as a Treatment for Gestational Diabetes
Source: ClinicalTrials.gov NCT01613807 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Jun 2022
Primary outcomePrimary: Hemoglobin A1C — 5.5; 5.6 A1c percent
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Evaluation of the Safety and Efficacy of Humalog® Mix50/50TM administered as 3 injections daily to Humalog® plus Humulin N® insulin administered as 6 separate injections daily in terms of glucose control for women with Gestational Diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1C |
5.5; 5.6 | — |
| SECONDARY Birthweight of Infant |
3178; 3375 | — |
Eligibility Criteria
Inclusion Criteria
- Pregnant and at least 13 weeks gestation
- Diagnosed with gestational diabetes mellitus
- Failed diet therapy
Exclusion Criteria
- 2+ protein
- blood pressure >140/80 mmHg
- hematocrit <30%
- refusal to take insulin
- inability to understand instructions or to consent to participate.
Data sourced from ClinicalTrials.gov (NCT01613807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.