Insulin Detemir vs NPH for Gestational Diabetes

(DETERMINE Trial)

Overseen By Christina Han, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Los Angeles

Must be taking: Insulin

Disqualifiers: Type 1 diabetes, Renal insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Throughout pregnancy

336 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether Insulin Detemir or NPH better reduces the risk of low blood sugar in newborns when their mothers have gestational diabetes. It includes two groups: one receiving Insulin Detemir (Levemir) and the other receiving Insulin NPH (Humulin N or Novolin N). Pregnant women with gestational diabetes or type 2 diabetes requiring insulin may be suitable for this trial. The focus is on improving health outcomes for both mothers and their babies during pregnancy. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it involves using insulin detemir or NPH for managing blood sugar during pregnancy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that insulin detemir is generally safe for use during pregnancy. Studies involving over 4,500 pregnancies have found no increased risk of birth defects or harm to the baby. Additional research on 250 more pregnancies also found no negative effects on pregnancy outcomes.

Similarly, insulin NPH, a long-acting insulin, has been safely used for many years to help pregnant women with diabetes control their blood sugar levels.

Both treatments are well-tolerated, and these studies have reported no major safety concerns, making them reliable options for managing blood sugar during pregnancy. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for gestational diabetes?

Researchers are excited about Insulin Detemir for gestational diabetes because it offers a more stable and predictable blood sugar control compared to traditional NPH insulin. Unlike NPH insulin, which can have variable absorption and peaks, Insulin Detemir provides a smoother and longer-lasting action, reducing the risk of blood sugar swings. This stability can lead to fewer hypoglycemic episodes, making it a potentially safer option for pregnant women managing gestational diabetes.

What evidence suggests that this trial's treatments could be effective for gestational diabetes?

This trial will compare Insulin Detemir and Insulin NPH for managing gestational diabetes. Studies have shown that insulin detemir is as effective and safe as insulin NPH for women with gestational diabetes. Research indicates that both types of insulin help control blood sugar levels and yield similar results for mothers and babies. One study found no major differences in pregnancy outcomes or newborn health when comparing insulin detemir to NPH. This suggests that both treatments effectively manage blood sugar during pregnancy. Therefore, whichever insulin is chosen in this trial, the results for controlling gestational diabetes are likely to be similar. ^{2 6 7 8 9}

Who Is on the Research Team?

Christina S Han, MD

Principal Investigator

University of California, Los Angeles

Michael Richley, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for pregnant women with Type 2 or gestational diabetes needing insulin. It's not for those under 18, with a planned early delivery, pre-pregnancy insulin use, type 1 diabetes, HIV/Hepatitis infections, fetal malformations, kidney/liver issues, or expecting multiples.

Inclusion Criteria

I am pregnant, have diabetes (type 2 or gestational), and need insulin.

Exclusion Criteria

You were already using insulin before getting pregnant.

You are allergic to NPH or insulin detemir.

I have long-term kidney or liver problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either insulin detemir or insulin NPH to control blood sugars during pregnancy

Throughout pregnancy

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neonatal outcomes

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Insulin Detemir
• Insulin NPH

Trial Overview The DETERMINE study compares the effects of two types of insulin on newborns' blood sugar levels when their mothers have Type 2 or gestational diabetes: Insulin Detemir versus Insulin NPH.

How Is the Trial Designed?

Group I: Insulin Detemir Experimental Treatment 1 Intervention

Patients are to receive insulin detemir as long acting insulin to control blood sugars

Group II: Insulin NPH Active Control 1 Intervention

Patients are to receive insulin NPH as long acting insulin to control blood sugars

Insulin Detemir is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Levemir for:

• Type 1 diabetes mellitus
• Type 2 diabetes mellitus

Approved in United States as Levemir for:

• Type 1 diabetes mellitus
• Type 2 diabetes mellitus

Approved in Canada as Levemir for:

• Type 1 diabetes mellitus
• Type 2 diabetes mellitus

Approved in Japan as Levemir for:

• Type 1 diabetes mellitus
• Type 2 diabetes mellitus

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

Insulin detemir significantly reduces the risk of maternal hypoglycemic events compared to neutral protamine Hagedorn (NPH) insulin, based on a meta-analysis of five randomized controlled trials involving 1450 pregnant women with diabetes.

Insulin detemir is also associated with a longer gestational age at delivery, suggesting a lower risk of prematurity compared to NPH, highlighting its potential benefits for pregnant women requiring insulin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of insulin detemir versus NPH in the treatment of diabetes during pregnancy: Systematic review and meta-analysis of randomized controlled trials. Athanasiadou, KI., Paschou, SA., Stamatopoulos, T., et al.[2022]

Insulin detemir (Levemir) offers a long-acting and consistent insulin option for patients with type 1 or type 2 diabetes, providing a predictable effect with less variability in blood sugar control compared to NPH insulin.

It is at least as effective as NPH in managing overall blood sugar levels while reducing the risk of nocturnal hypoglycemia and causing less weight gain, making it a favorable choice for basal insulin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Insulin detemir (Levemir)]. Scheen, AJ., Radermecker, RP., Philips, JC., et al.[2015]

In a study of 192 women with gestational diabetes mellitus, insulin detemir resulted in slightly better glycemic control, with lower HbA1c levels compared to insulin NPH, indicating its efficacy in managing blood sugar during pregnancy.

Both insulin detemir and NPH were found to be safe, with no reported cases of hypoglycemia or allergic reactions, suggesting that detemir is a viable alternative to NPH for treating gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of treatment with insulin detemir and NPH in women with gestational diabetes mellitus: glycemic control and pregnancy outcomes. A retrospective study. Kazakou, P., Paschou, SA., Mitropoulou, M., et al.[2023]

In a study of 240 pregnant women with diabetes, insulin detemir (IDet) was found to lower fasting plasma glucose levels more effectively and faster than neutral protamine Hagedorn (NPH) insulin after one week of treatment.

IDet also resulted in a significantly lower incidence of hypoglycemia compared to NPH, while both treatments showed similar maternal and neonatal outcomes, making IDet a preferable option for managing gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the efficacy and safety of insulin detemir versus neutral protamine hagedorn insulin in treatment of diabetes during pregnancy: a randomized, controlled study. Ji, J., He, Z., Yang, Z., et al.[2022]

Insulin detemir (IDet) is shown to be noninferior to insulin neutral protamine Hagedorn (NPH) for managing gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) in pregnant women, based on a study involving 87 participants.

The study found no significant differences in blood glucose control, maternal weight gain, or perinatal outcomes between the two insulin types, but the NPH group experienced more hypoglycemic events, suggesting IDet may be a safer option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. Herrera, KM., Rosenn, BM., Foroutan, J., et al.[2016]

In a study involving 310 pregnant women with type 1 diabetes, insulin detemir (IDet) demonstrated noninferior efficacy compared to neutral protamine Hagedorn (NPH) insulin, with similar A1C levels at 36 weeks of gestation (6.27% for IDet vs. 6.33% for NPH).

IDet also resulted in significantly lower fasting plasma glucose levels at both 24 weeks (96.8 mg/dL vs. 113.8 mg/dL) and 36 weeks (85.7 mg/dL vs. 97.4 mg/dL) without increasing the risk of hypoglycemia compared to NPH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Mathiesen, ER., Hod, M., Ivanisevic, M., et al.[2022]

A systematic review of seven studies involving 1396 patients found that both insulin detemir (IDet) and insulin neutral protamine Hagedorn (NPH) are equally effective in managing blood sugar levels during pregnancy, as indicated by similar HbA1c reductions.

Insulin detemir was associated with a longer gestational age at delivery and a lower risk of hypoglycemic events compared to insulin NPH, suggesting it may be a safer option for pregnant women with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of insulin detemir vs. insulin NPH in pregnant women with diabetes: a systematic review and meta-analysis. Fatima, K., Siddiqi, AK., Shakil, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10651542/

Comparison of treatment with insulin detemir and NPH in ... The objective of this retrospective study was to compare glycemic control, pregnancy outcomes, and neonatal outcomes in women with gestational diabetes ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37775682/

Comparison of treatment with insulin detemir and NPH in ... Conclusion: The use of insulin detemir was found to be equally effective and safe compared to NPH in women with GDM. Keywords: Detemir; ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03377699?tab=results

Research Study Comparing Insulin Degludec to ... Insulin degludec versus insulin detemir, both in combination with insulin aspart, in the treatment of pregnant women with type 1 diabetes (EXPECT): an open ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.3233/HAB-190385

Comparison between the effect of regular human insulin ... Comparison of treatment with insulin Detemir and NPH in women with gestational diabetes mellitus: glycemic control and pregnancy outcomes. Go to citation ...

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/021536s060lbl.pdf

LEVEMIR® (insulin detemir) injection, for subcutaneous use In a randomized, parallel group, open label clinical trial that included 152 pregnant women with type 1 diabetes who were administered LEVEMIR once or twice ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25731934/

The use of insulin detemir during pregnancy: a safety ... Though data is limited, its safety and efficacy is probably comparable to human insulin, and in some aspects superior to it. More data, specifically for IDet in ...

7. ema.europa.eu ema.europa.eu/en/documents/product-information/levemir-epar-product-information_en.pdf

Levemir, INN-insulin detemir - European Medicines Agency Post-marketing data in pregnant women using Levemir, with more than 4,500 pregnancy outcomes do not indicate any increased risk of malformative or feto ...

8. medicines.ie medicines.ie/medicines/levemir-flexpen-insulin-detemir-100-units-ml-solution-for-injection-in-pre-filled-pen-32682/doc-history

Levemir FlexPen (Insulin detemir) 100 units/ml solution for ... Post-marketing data from an additional 250 outcomes from pregnant women exposed to Levemir indicate no adverse effects of insulin detemir on pregnancy and no ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/insulin-detemir-subcutaneous-route/description/drg-20067537

Insulin detemir (subcutaneous route) - Side effects & dosage Insulin detemir is a long-acting insulin that works slowly over 24 hours. You may have to use insulin detemir in combination with another type of insulin or ...