RCT Glargine vs NPH for Treatment of DM in Pregnancy
Recruiting
Phase 3
Interventional Study
Diabetes Mellitus in Pregnancy
Type 2 Diabetes Mellitus (T2DM)
Gestational Diabetes Mellitus, Class A2
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 160 (estimated)
- Sponsor
- Loyola University · Other
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About This Trial
We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, glargine and detemir being the most commonly used forms of basal insulin. Outside of pregnancy, NPH is …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patient requiring initiation of insulin therapy for Gestational Diabetes Mellitus or Type 2 Diabetes Mellitus in pregnancy
* At least 18 years old
* Insulin started prior to 34 weeks gestation
* Established prenatal care by 14 weeks gestation
Exclusion Criteria:
* Those unde…
Contacts