Diabetes During PregnancyPhase 2NCT01662921
Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes
A Phase 2 study testing NPH, Insulin LISPRO and Insulin glulisine in people with Diabetes During Pregnancy, run by Sansum Diabetes Research Institute at 1 site in United States.
Trial summary
We hypothesize that insulin glulisine is non-inferior to currently proven rapid-acting insulin lispro when used in a basal/bolus regimen to treat hyperglycemia in patients with gestational diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes During Pregnancy
- What is being tested?
- NPH, Insulin LISPRO and Insulin glulisine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 31 Aug 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent to participate in clinical trial
- Pregnant and 20-30 weeks gestation
- Diagnosed with gestational diabetes
- Failed diet therapy (failed lifestyle modification will be defined as 10% or greater SMBG values above pre-meal <90mg/dL and post prandial < 120mg/dL
- Eat at least 2 meals per day
Who cannot join
- Pregnant women <18 years old
- Blood pressure > 140/80 mmHg
- A1C equal to or greater than 6.5% at time of enrollment
- Pre-pregnancy BMI > 40Kg/m squared
- Evidence of any fetal anomaly on any fetal ultrasound
- Currently using hypoglycemic agent
Show all 10Show fewer
- Refusal to use insulin before meals
- Inability to understand instructions or to consent to participate
- Pregnant women with history of T1DM or T2DM
- Clinical judgment by investigator that patient is inappropriate for clinical trial or has a metabolic disorder that could interfere with results
Trial locations and contacts
1 site in 1 country.
United States1 site
William Sansum Diabetes Center
Santa Barbara, California, 93105
About this study
Official title: Non-inferiority Trial Comparing Insulin Glulisine to Insulin Lispro as Part of a Basal-bolus Insulin Regimen for the Treatment of Gestational Diabetes.
We hypothesize that insulin glulisine is non-inferior to currently proven rapid-acting insulin lispro when used in a basal/bolus regimen to treat hyperglycemia in patients with gestational diabetes mellitus.
Read the detailed description
To date, only two rapid-acting insulin analogs have been shown to be safe and effective for the treatment of diabetes during pregnancy: insulin aspart and insulin lispro.
The pharmacokinetics and pharmacodynamics of insulin glulisine are unique and insulin glulisine may be the best rapid-acting analog for the treatment of post-prandial hyperglycemia. We believe that insulin glulisine should be evaluated in women with gestational diabetes for its potential efficacy.
- Conditions
- Diabetes During Pregnancy
- Being tested
- NPH, Insulin LISPRO, Insulin glulisine
- Keywords
- bolus treatment
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPHDrug
Also called Humulin N, Novolin N
Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age
Insulin LISPRODrug
Also called Humalog
Insulin lispro dosing will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days
Insulin glulisineDrug
Also called Apidra
Insulin glulisine will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days
| Study group | Role | What they receive |
|---|---|---|
| NPH and insulin lispro | Active comparator | Patients diagnosed with diabetes during pregnancy will be randomized to long acting insulin NPH and short acting insulin lispro in a basal bolus regimen to treat post prandial hyperglycemia using a dosing schedule of 50% NPH calculated by the patients weight and gestational age and 50% lispro pending their last three SMPG average. Receives: Drug: NPH; Drug: Insulin LISPRO |
| NPH and insulin glulisine | Active comparator | Patients with a diagnosis of diabetes during pregnancy will be randomized to using long acting insulin NPH and short acting insulin glulisine as treatment for post prandial hyperglycemia with a 50% NPH dosing schedule based on the weight and gestational age and 50% glulisine schedule based on their last three SMBG result average. Receives: Drug: NPH; Drug: Insulin glulisine |
What is being measured
The primary outcome is the main question the study is designed to answer.
show that insulin glulisine is non-inferior to insulin lispro in a basal/bolus regimen to treat hyperglycemia in patient with gestational diabetes mellitus
compare average 1-hour post prandial SMBG measurements between patients randomized to insulin glulisine or insulin lispro
Measured: week 4 of insulin treatment
Secondary outcomes (3)
Serum blood glucose area under the curve (AUC) at one 4-hour in-clinic meal challenge
patients will come to the study site under fasting conditions and eat a standardized meal in the morning post administration of insulin NPH and their randomized bolus insulin.
Measured: week 2 of insulin treatment
Compare A1C at enrollment and weekly until delivery
A1C is measured weekly at each pregnancy visit up to 26 visits. Subjects are enrolled at 20-32 weeks gestation and have weekly visits to obtain A1C through delivery, and again at the 6-week postpartum visit.
Measured: up to 36 weeks
Compare incidence of hypoglycemic episodes <60 mg/dL with symptoms
Hypoglycemic episodes since the last visit will be reported at each pregnancy visit, usually weekly, from enrollment at 10-30 weeks gestation through delivery and at the 6-week postpartum visit if continuing to take insulin.
Measured: up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startApr 2013
- Primary completion31 Jan 2015
- Study completion31 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes During PregnancyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Kristin Castorino, DO, Principal investigator, Sansum Diabetes Research InstituteLeonie Mattison, PhD, Study director, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662921
- Sponsor's protocol ID
- APIDRL06229
- Status last verified
- Apr 2018
- First submitted
- 7 Aug 2012
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
1. Centers for Disease Control and Prevention: National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011.
Castorino K, Jovanovic L. Pregnancy and diabetes management: advances and controversies. Clin Chem. 2011 Feb;57(2):221-30. doi: 10.1373/clinchem.2010.155382. Epub 2010 Dec 9.
PubMed 21148303HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
PubMed 18463375Jovanovic L, Pettitt DJ. Treatment with insulin and its analogs in pregnancies complicated by diabetes. Diabetes Care. 2007 Jul;30 Suppl 2:S220-4. doi: 10.2337/dc07-s220. No abstract available.
PubMed 17596476Arnolds S, Rave K, Hovelmann U, Fischer A, Sert-Langeron C, Heise T. Insulin glulisine has a faster onset of action compared with insulin aspart in healthy volunteers. Exp Clin Endocrinol Diabetes. 2010 Oct;118(9):662-4. doi: 10.1055/s-0030-1252067. Epub 2010 Apr 28.
PubMed 20429049Manderson JG, Patterson CC, Hadden DR, Traub AI, Ennis C, McCance DR. Preprandial versus postprandial blood glucose monitoring in type 1 diabetic pregnancy: a randomized controlled clinical trial. Am J Obstet Gynecol. 2003 Aug;189(2):507-12. doi: 10.1067/s0002-9378(03)00497-6.
PubMed 14520226
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Trial Comparing Insulin Glulisine to Insulin Lispro as Part of a Basal-bolus Insulin Regimen for the Treatment of Gestational Diabetes.
- ClinicalTrials.gov ID
- NCT01662921
- Acronym / sponsor ID
- APIDRL06229
- Conditions
- Diabetes During Pregnancy
- Keywords
- bolus treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Apr 2013 (actual)
- Primary completion
- 31 Jan 2015 (actual)
- Study completion
- 31 Aug 2015 (actual)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that insulin glulisine is non-inferior to currently proven rapid-acting insulin lispro when used in a basal/bolus regimen to treat hyperglycemia in patients with gestational diabetes mellitus.
Detailed description
To date, only two rapid-acting insulin analogs have been shown to be safe and effective for the treatment of diabetes during pregnancy: insulin aspart and insulin lispro.
The pharmacokinetics and pharmacodynamics of insulin glulisine are unique and insulin glulisine may be the best rapid-acting analog for the treatment of post-prandial hyperglycemia. We believe that insulin glulisine should be evaluated in women with gestational diabetes for its potential efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPH and insulin lispro | Active comparator | Drug: NPH, Drug: Insulin LISPROPatients diagnosed with diabetes during pregnancy will be randomized to long acting insulin NPH and short acting insulin lispro in a basal bolus regimen to treat post prandial hyperglycemia using a dosing schedule of 50% NPH calculated by the patients weight and gestational age and 50% lispro pending their last three SMPG average. |
| NPH and insulin glulisine | Active comparator | Drug: NPH, Drug: Insulin glulisinePatients with a diagnosis of diabetes during pregnancy will be randomized to using long acting insulin NPH and short acting insulin glulisine as treatment for post prandial hyperglycemia with a 50% NPH dosing schedule based on the weight and gestational age and 50% glulisine schedule based on their last three SMBG result average. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed Consent to participate in clinical trial
- Pregnant and 20-30 weeks gestation
- Diagnosed with gestational diabetes
- Failed diet therapy (failed lifestyle modification will be defined as 10% or greater SMBG values above pre-meal <90mg/dL and post prandial < 120mg/dL
- Eat at least 2 meals per day
Key exclusion criteria (10 listed)
- Pregnant women <18 years old
- Blood pressure > 140/80 mmHg
- A1C equal to or greater than 6.5% at time of enrollment
- Pre-pregnancy BMI > 40Kg/m squared
- Evidence of any fetal anomaly on any fetal ultrasound
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 |
|---|---|---|
| NPHAlso: Humulin N, Novolin NLong acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age | Drug | NPH and insulin glulisine, NPH and insulin lispro |
| Insulin LISPROAlso: HumalogInsulin lispro dosing will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days | Drug | NPH and insulin lispro |
| Insulin glulisineAlso: ApidraInsulin glulisine will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days | Drug | NPH and insulin glulisine |
Primary outcome
show that insulin glulisine is non-inferior to insulin lispro in a basal/bolus regimen to treat hyperglycemia in patient with gestational diabetes mellitus
Time frame: week 4 of insulin treatment
compare average 1-hour post prandial SMBG measurements between patients randomized to insulin glulisine or insulin lispro
3 secondary outcomes
Serum blood glucose area under the curve (AUC) at one 4-hour in-clinic meal challenge
Time frame: week 2 of insulin treatment
Compare A1C at enrollment and weekly until delivery
Time frame: up to 36 weeks
Compare incidence of hypoglycemic episodes <60 mg/dL with symptoms
Time frame: up to 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Background1. Centers for Disease Control and Prevention: National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011.
- Background: PubMed 21148303Castorino K, Jovanovic L. Pregnancy and diabetes management: advances and controversies. Clin Chem. 2011 Feb;57(2):221-30. doi: 10.1373/clinchem.2010.155382. Epub 2010 Dec 9.
- Background: PubMed 18463375HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
- Background: PubMed 17596476Jovanovic L, Pettitt DJ. Treatment with insulin and its analogs in pregnancies complicated by diabetes. Diabetes Care. 2007 Jul;30 Suppl 2:S220-4. doi: 10.2337/dc07-s220. No abstract available.
- Background: PubMed 20429049Arnolds S, Rave K, Hovelmann U, Fischer A, Sert-Langeron C, Heise T. Insulin glulisine has a faster onset of action compared with insulin aspart in healthy volunteers. Exp Clin Endocrinol Diabetes. 2010 Oct;118(9):662-4. doi: 10.1055/s-0030-1252067. Epub 2010 Apr 28.
- Background: PubMed 14520226Manderson JG, Patterson CC, Hadden DR, Traub AI, Ennis C, McCance DR. Preprandial versus postprandial blood glucose monitoring in type 1 diabetic pregnancy: a randomized controlled clinical trial. Am J Obstet Gynecol. 2003 Aug;189(2):507-12. doi: 10.1067/s0002-9378(03)00497-6.
- Web page for Sansum Diabetes Research InstituteLink provided by the sponsor.
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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
Leonie Mattison, PhD study director
Sansum Diabetes Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NPH, Insulin LISPRO and Insulin glulisine in people with Diabetes During Pregnancy, run by Sansum Diabetes Research Institute at 1 site in United States.
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 5 inclusion and 10 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
show that insulin glulisine is non-inferior to insulin lispro in a basal/bolus regimen to treat hyperglycemia in patient with gestational diabetes mellitus (time frame: week 4 of insulin treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01662921, which also lists 6 linked publications.
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 18 Apr 2018.