Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes

NCT03770767 | Completed Phase 3

• 1 other identifier: U1111
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

A randomised controlled, open-label trial in an unselected cohort of pregnant women with type 1 or type 2 diabetes allocated to insulin Fiasp® or insulin NovoRapid® during pregnancy and lactation.

Conditions

Diabetes Mellitus; Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

• Birth weight standard deviation score

  Offspring birth weight (measured as standard deviation score) adjusted for gestational age and gender

  At delivery

Secondary Outcomes (12)

• HbA1c levels

  At inclusion in early pregnancy, at 21 weeks in pregnancy, at 33 weeks in pregnancy, at 36 weeks in pregnancy, at 1 month after delivery, at 3 months after delivery

• Postprandial self-monitoring of plasma glucose (SMPG) levels

  9 months

• Preprandial self-monitoring of plasma glucose (SMPG) levels

  9 months

• Insulin treatment and dose (IU) including insulin pump settings

  At inclusion in early pregnancy, at 21 weeks in pregnancy, at 33 weeks in pregnancy, at 36 weeks in pregnancy, at 1 month after delivery, at 3 months after delivery

• Continuous glucose monitoring data

  9 months

Study Arms (2)

Intervention with insulin Fiasp

EXPERIMENTAL

Women randomized to insulin Fiasp

Drug: Faster-acting Aspart insulin Fiasp

Control (insulin Novorapid)

ACTIVE COMPARATOR

Women randomized to insulin NovoRapid

Drug: Control (insulin Novorapid)

Interventions

Faster-acting Aspart insulin Fiasp DRUG

Randomization to treatment with insulin Fiasp

Also known as: Insulin Fiasp

Intervention with insulin Fiasp

Control (insulin Novorapid) DRUG

Randomization to standard treatment with insulin Novorapid

Also known as: First generation insulin analog

Control (insulin Novorapid)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women, age ≥ 18 years
• Duration of type 1 diabetes (or mature onset of diabetes in the young) ≥ 12 months
• Type 2 diabetes (any duration)
• Pregnant with an intrauterine singleton living fetus confirmed by an ultrasound scan between 8+0 and 13+6 gestational weeks
• Routine use of insulin pump therapy, insulin detemir, insulin degludec, insulin glargine, insulin abasaglar, insulin toujeo or Neutral Protamine Hagedorn insulin and willing to continue routine treatment modality
• Women with type 1 diabetes using an insulin pump compatible with trial products
• Women with type 2 diabetes treated with diet, oral antidiabetic therapy or pre-mixed insulin before pregnancy and willing to change to trial medication according to randomization or to an appropriate long-acting insulin analogue, as indicated
• Proficiency in Danish to understand oral and written information

You may not qualify if:

• Severe mental or psychiatric barriers or concurrent disease on the decision of the principal investigator

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Center for Pregnant Women with Diabetes, Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (3)

• Norgaard SK, Soholm JC, Mathiesen ER, Norgaard K, Clausen TD, Holmager P, Do NC, Damm P, Ringholm L. Faster-acting insulin aspart versus insulin aspart in the treatment of type 1 or type 2 diabetes during pregnancy and post-delivery (CopenFast): an open-label, single-centre, randomised controlled trial. Lancet Diabetes Endocrinol. 2023 Nov;11(11):811-821. doi: 10.1016/S2213-8587(23)00236-X. Epub 2023 Oct 4.

  PMID: 37804858 DERIVED

• Norgaard SK, Mathiesen ER, Norgaard K, Ringholm L. Comparison of Glycemic Metrics Measured Simultaneously by Intermittently Scanned Continuous Glucose Monitoring and Real-Time Continuous Glucose Monitoring in Pregnant Women with Type 1 Diabetes. Diabetes Technol Ther. 2021 Oct;23(10):665-672. doi: 10.1089/dia.2021.0109. Epub 2021 Jun 25.

  PMID: 34086494 DERIVED

• Norgaard SK, Mathiesen ER, Norgaard K, Clausen TD, Damm P, Ringholm L. CopenFast trial: Faster-acting insulin Fiasp versus insulin NovoRapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation - a randomised controlled trial. BMJ Open. 2021 Apr 9;11(4):e045650. doi: 10.1136/bmjopen-2020-045650.

  PMID: 33837106 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Pregnancy Complications

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Lene Ringholm

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 10, 2018
• Study Start: November 11, 2019
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)