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This trial is conducted in the United States of America (USA). The purpose of this study is to test whether NovoLog (insulin aspart) is a safe and at least as effective alternative to regular human insulin for the control of blood glucose after meals in women who develop diabetes during pregnancy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human insulin | Drug | |||
| insulin NPH | Drug | |||
| insulin aspart | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial glycemic control |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (glycosylated haemoglobin A1c) | ||
| Postprandial endogenous insulin secretory response | ||
| Hypoglycemic episodes |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Santa Barbara | California | 93105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12502678 | Result | Pettitt DJ, Ospina P, Kolaczynski JW, Jovanovic L. Comparison of an insulin analog, insulin aspart, and regular human insulin with no insulin in gestational diabetes mellitus. Diabetes Care. 2003 Jan;26(1):183-6. doi: 10.2337/diacare.26.1.183. | |
| 17888133 | Result | Pettitt DJ, Ospina P, Howard C, Zisser H, Jovanovic L. Efficacy, safety and lack of immunogenicity of insulin aspart compared with regular human insulin for women with gestational diabetes mellitus. Diabet Med. 2007 Oct;24(10):1129-35. doi: 10.1111/j.1464-5491.2007.02247.x. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D007336 | Insulin, Isophane |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Adverse events |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D049528 | Insulin, Long-Acting |
| D061266 | Insulin, Short-Acting |