Recruiting
Phase 3

Glargine vs. NPH

Sponsor:

Loyola University

Code:

NCT06619301

Conditions

Diabetes Mellitus in Pregnancy

Type 2 Diabetes Mellitus (T2DM)

Gestational Diabetes Mellitus, Class A2

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Insulin glargine

insulin NPH

Study Details

Brief summary:

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.

Conditions

Diabetes Mellitus in Pregnancy

Type 2 Diabetes Mellitus (T2DM)

Gestational Diabetes Mellitus, Class A2

Study ID

NCT06619301

Start date

Apr 1, 2024

Status verified date

Sep, 2024

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 under the age of 18 years old
  • Those unable to consent in english
  • Allergy to insulin
  • Controlled with only diet modification or the use of oral antihyperglycemics
  • Has diagnosis of Type 1 Diabetes Mellitus
  • Receiving insulin through an insulin pump

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Insulin glargine

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

Insulin NPH is a current medication used in pregnancy for diabetes mellitus. It has been used as the standard form of insulin.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Joana Lopes Perdigao, MD

708-216-4033joana.perdigao@lumc.edu

Nuong Truong, MD

708-216-4033nuong.t.truong@luhs.org

Locations

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Joana Lopes Perdigao, MD

708-216-4033joana.perdigao@lumc.edu

Nuong Truong, MD

708-216-4033nuong.t.truong@luhs.org

Principal Investigator:

Joana Lopes Perdigao, MD

More Information

Sponsor

Loyola University

Last update posted

Oct 1, 2024

Last verified

Sep, 2024

Keywords

  • Glargine
  • NPH
  • Hypoglycemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loyola University on 2024-10-01.