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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Lois Jovanovic, MD, Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier:
NCT01613807
First received: June 5, 2012
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

Humalog® Mix50/50TM administered as 3 injections daily is equivalent to Humalog® plus Humulin N® insulin administered as 6 separate injections daily in terms of glucose control, but may have some advantages due to increased ease of use.


Condition Intervention Phase
Gestational Diabetes Mellitus
Drug: Insulin LISPRO
Drug: Insulin, Long-Acting and Insulin LISPRO
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Humalog® Mix50/50(tm) for the Treatment of Insulin Requiring Gestational Diabetes

Resource links provided by NLM:


Further study details as provided by Sansum Diabetes Research Institute:

Primary Outcome Measures:
  • Fasting self-monitored blood glucose measurements [ Time Frame: Pregnancy (approximately 28 weeks) ] [ Designated as safety issue: Yes ]
    Compare the efficacy and safety of three daily injections of Humalog® Mix50/50TM to six daily injections of Humalog® and Humulin N® insulin, by fasting glucose measurements.


Enrollment: 40
Study Start Date: October 2008
Study Completion Date: October 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mix 50/50
3 doses of Mix 50/50 at mealtime
Drug: Insulin LISPRO
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.
Other Name: Humalog® Mix50/50™
Active Comparator: Usual insulin regimen
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 LISPRO
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.
Other Names:
  • Humalin N(r)
  • Humalog (r)

Detailed Description:

Controlling hyperglycemia during pregnancy decreases the risk of adverse neonatal and maternal outcomes. Not only must fasting glucose be normalized, but clinical evidence also indicates that controlling postprandial hyperglycemia will significantly reduce the risk of adverse neonatal and maternal outcomes.

Standard therapy to achieve near-normal glycemia in gestational diabetes involves combining intermediate-acting basal (NPH) insulin with rapid-acting insulin (insulin lispro), thereby requiring 6 daily injections. Premixed Humalog® Mix50/50TM has the potential advantage over combination rapid-acting plus NPH insulin because it involves fewer injections, and those injections are associated with mealtime. The potential downside to the premixed formulation is nocturnal hypoglycemia associated with the time lag between the dinner and breakfast dose. This study will evaluate the efficacy and safety of Humalog® Mix50/50TM compared to that of Humalog® plus Humulin N® insulin for the treatment of insulin-requiring patients with gestational diabetes mellitus, while monitoring glucose control, intrauterine growth and assessing pregnancy outcomes.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • <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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613807

Sponsors and Collaborators
Sansum Diabetes Research Institute
Eli Lilly and Company
Investigators
Principal Investigator: Lois Jovanovic, MD Sansum Diabetes Research Institute
  More Information

No publications provided

Responsible Party: Lois Jovanovic, MD, Chief Scientific Officer, Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT01613807     History of Changes
Other Study ID Numbers: SDRI 08-01, F3Z-US-X031
Study First Received: June 5, 2012
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Sansum Diabetes Research Institute:
gestational diabetes mellitus
insulin analogues in pregnancy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications
Biphasic Insulins
Insulin
Insulin Lispro
Insulin, Globin Zinc
Insulin, Isophane
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014