RCT Glargine vs NPH for Treatment of DM in Pregnancy

Part of paid clinical trials in Maywood, Illinois.

Sponsor
Loyola University
Study ID
NCT06619301
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Diabetes Mellitus in Pregnancy
  • Gestational Diabetes Mellitus, Class A2
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Insulin glargine — DRUG
    Insulin Glargine is regularly used outside of pregnancy and its efficacy is well documented. It is a current medication we regularly use in pregnancy, however, there is limited data for comparison to the standard, NPH.
  • insulin NPH — DRUG
    Insulin NPH is a current medication used in pregnancy for diabetes mellitus. It has been used as the standard form of insulin.

Study Details

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 rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients. Detemir has been well studied in pregnancy and found to be noninferior to NPH. Unfortunately, glargine has not been as well studied in pregnancy. Thus, with this study we want to compare glargine and NPH. The purpose of this study is to compare two different forms of insulin (Glargine and NPH) that we regularly use to manage diabetes mellitus in pregnancy.

Key Dates

Start date
Apr 1, 2024
Status verified
Sep 2024
Primary completion
Apr 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Insulin Glargine
    Insulin Glargine dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus.
  • Active Comparator: Insulin NPH
    Insulin NPH dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus.

Primary Outcome Measure

Hypoglycemia [ Time Frame: From initiation of insulin therapy to delivery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Loyola University Medical CenterMaywoodIllinois60153
Joana Lopes Perdigao, MD
[email protected]
708-216-4033
Nuong Truong, MD
[email protected]
708-216-4033
Joana Lopes Perdigao, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Loyola University Medical Center· Maywood, IL

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