Diabetes During Pregnancy Clinical Trial
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.
| Verified date | April 2018 |
| Source | Sansum Diabetes Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 17 |
| Est. completion date | August 31, 2015 |
| Est. primary completion date | January 31, 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | William Sansum Diabetes Center | Santa Barbara | California |
| Lead Sponsor | Collaborator |
|---|---|
| Sansum Diabetes Research Institute | Sanofi |
United States,
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.
9. Manderson JG, Patterson CC, Hadden DR, Traub Al, Ennis C, McCance DR. Preprandial versus postprandial blood glucose monitoring in type 1 diabetic pregnancy: a randomized controlled clinical trial. Am J Obstet gynecol 189(2):507 512, 2003.Jovanovic L, Druzin M, Peterson CM. The effect of euglycemia on the outcome of pregnancy in insulin-dependent diabetics as compared to normal controls. Am J Med. 71:921-927, 1981
Arnolds S, Rave K, Hövelmann 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. — View Citation
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. Review. — View Citation
HAPO 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. — View Citation
Jovanovic 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. Review. Erratum in: Diabetes Care. 2007 Dec;30(12):3154. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Compare incidence of birth weight >90th percentile | delivery | ||
| Other | Compare incidence of primary cesarean section | delivery | ||
| Primary | 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 | week 4 of insulin treatment | |
| Secondary | 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. | week 2 of insulin treatment | |
| Secondary | 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. | up to 36 weeks | |
| Secondary | 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. | up to 36 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01907516 -
Managing Diabetes in Pregnancy Using Cell Phone/Internet Technology
|
N/A |