Gestational Diabetes MellitusPhase 4NCT01613807
Humalog® Mix50/50(tm) as a Treatment for Gestational Diabetes
A Phase 4 study testing Insulin LISPRO and Insulin, Long-Acting and Insulin in people with Gestational Diabetes Mellitus, run by Sansum Diabetes Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Insulin LISPRO and Insulin, Long-Acting and Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Oct 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant and at least 13 weeks gestation
- Diagnosed with gestational diabetes mellitus
- Failed diet therapy
Who cannot join
- <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.
About this study
Official title: Phase 4 Humalog® Mix50/50(tm) for the Treatment of Insulin Requiring Gestational Diabetes
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.
Read the 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.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Insulin LISPRO, Insulin, Long-Acting and Insulin
- Keywords
- gestational diabetes mellitus, insulin analogues in pregnancy
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin LISPRODrug
Also called Humalog® Mix50/50™
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.
Insulin, Long-Acting and InsulinDrug
Also called Humalin N(r), Humalog (r)
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.
| Study group | Role | What they receive |
|---|---|---|
| Mix 50/50 | Experimental | Insulin LISPRO: 3 doses of Humalog® Mix50/50™ at mealtime. Receives: 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 Receives: Drug: Insulin, Long-Acting and Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During Pregnancy (at approximately 28 weeks gestation)
Secondary outcomes (1)
Birthweight of Infant
Birthweight of infant born to mother with gestational diabetes using insulin
Measured: End of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startOct 2008
- Primary completionJun 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Kristin Castorino, DO, Sansum Diabetes Research Institute
- Investigators
- Kristin Castorino, DO, Principal investigator, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613807
- Sponsor's protocol ID
- SDRI 08-01
- Other IDs
- F3Z-US-X031
- Status last verified
- Jun 2022
- First submitted
- 5 Jun 2012
- Last updated
- 8 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Humalog® Mix50/50(tm) for the Treatment of Insulin Requiring Gestational Diabetes
- ClinicalTrials.gov ID
- NCT01613807
- Acronym / sponsor ID
- SDRI 08-01
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- gestational diabetes mellitus, insulin analogues in pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Oct 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Posted 8 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mix 50/50 | Experimental | Drug: Insulin LISPROInsulin LISPRO: 3 doses of Humalog® Mix50/50™ at mealtime. |
| Usual insulin regimen | Active comparator | Drug: Insulin, Long-Acting and InsulinUsual 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 |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant and at least 13 weeks gestation
- Diagnosed with gestational diabetes mellitus
- Failed diet therapy
Key exclusion criteria (6 listed)
- <18 years old or over 45 years old
- urine dipstick >2+ protein
- blood pressure >140/80 mmHg
- hematocrit <30%
- refusal to take insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin LISPROAlso: Humalog® Mix50/50™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. | Drug | Mix 50/50 |
| Insulin, Long-Acting and InsulinAlso: Humalin N(r), Humalog (r)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. | Drug | Usual insulin regimen |
Primary outcome
Hemoglobin A1C
Time frame: During Pregnancy (at approximately 28 weeks gestation)
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.
1 secondary outcome
Birthweight of Infant
Time frame: End of pregnancy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Castorino, DO principal investigator
Sansum Diabetes Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin LISPRO and Insulin, Long-Acting and Insulin in people with Gestational Diabetes Mellitus, run by Sansum Diabetes Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1C (time frame: During Pregnancy (at approximately 28 weeks gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.