Humalog® Mix50/50(tm) as a Treatment for Gestational Diabetes

NCT01613807 | Completed Phase 4 Results DMC

• 2 other identifiers: SDRI 08-01F3Z-US-X031
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluation of the Safety and Efficacy of Humalog® Mix50/50TM administered as 3 injections daily to Humalog® plus Humulin N® insulin administered as 6 separate injections daily in terms of glucose control for women with Gestational Diabetes.

Conditions

Gestational Diabetes Mellitus

Keywords

gestational diabetes mellitus; insulin analogues in pregnancy

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C

  Compare the efficacy and safety of three daily injections of Humalog® Mix50/50TM to six daily injections of Humalog® and Humulin N® insulin, by hemoglobin A1C.

  During Pregnancy (at approximately 28 weeks gestation)

Secondary Outcomes (1)

• Birthweight of Infant

  End of pregnancy

Study Arms (2)

Mix 50/50

EXPERIMENTAL

Insulin LISPRO: 3 doses of Humalog® Mix50/50™ at mealtime.

Drug: Insulin LISPRO

Usual insulin regimen

ACTIVE COMPARATOR

Usual insulin regimen of insulin, Long-Acting and Insulin: 3 injections of Humalog(r) daily with meals; 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime

Drug: Insulin, Long-Acting and Insulin

Interventions

Insulin LISPRO DRUG

Humalog® Mix50/50™ \[50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)\], three times daily at mealtime. Dose determined by blood glucose history.

Also known as: Humalog® Mix50/50™

Mix 50/50

Insulin, Long-Acting and Insulin DRUG

Usual insulin regimen: Long-acting insulin three times daily on rising, mid-afternoon, and before bed, and insulin lispro three times daily at mealtime. Doses determined by blood glucose history and carbohydrate content of the meal.

Also known as: Humalin N(r), Humalog (r)

Usual insulin regimen

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant and at least 13 weeks gestation
• Diagnosed with gestational diabetes mellitus
• Failed diet therapy

You may not qualify if:

• \<18 years old or over 45 years old
• urine dipstick \>2+ protein
• blood pressure \>140/80 mmHg
• hematocrit \<30%
• refusal to take insulin
• inability to understand instructions or to consent to participate.

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• Eli Lilly and Company: collaborator

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Insulin Lispro; Insulin, Long-Acting

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Subjects in Humalog 50/50 Mix arm were limited to carbohydrates with meals. They were unable to bolus for carbohydrate-containing snacks.

Results Point of Contact

• Title: Dr. Kristin Castorino
• Organization: Sansum Diabetes Research Institute

kcastorino@sansum.org

8056827640

Study Officials

• Kristin Castorino, DO

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Physician

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 7, 2012
• Study Start: October 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 8, 2022
• Results First Posted: June 8, 2022

Record last verified: 2022-06