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This trial is conducted in the United States of America (USA). The aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing OAD therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart | Drug | |||
| insulin glargine | Drug | |||
| metformin | Drug | |||
| pioglitazone | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | after 28 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial glucose by 8-point SMBG | ||
| Number of subjects achieving HbA1c below 7% | ||
| Number of hypoglycemic episodes and adverse events |
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Inclusion Criteria:
Exclusion 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 | Concord | California | 94520 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15677776 | Result | Raskin P, Allen E, Hollander P, Lewin A, Gabbay RA, Hu P, Bode B, Garber A; INITIATE Study Group. Initiating insulin therapy in type 2 Diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care. 2005 Feb;28(2):260-5. doi: 10.2337/diacare.28.2.260. | |
| 17697056 | Result | Garber AJ, Ligthelm R, Christiansen JS, Liebl A. Premixed insulin treatment for type 2 diabetes: analogue or human? Diabetes Obes Metab. 2007 Sep;9(5):630-9. doi: 10.1111/j.1463-1326.2006.00654.x. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Weight change |
| Insulin dose |
| Los Angeles |
| California |
| 90057 |
| United States |
| Novo Nordisk Investigational Site | Walnut Creek | California | 94598 | United States |
| Novo Nordisk Investigational Site | Melbourne | Florida | 32901 | United States |
| Novo Nordisk Investigational Site | Melbourne | Florida | 32935 | United States |
| Novo Nordisk Investigational Site | West Palm Beach | Florida | 33401 | United States |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30318 | United States |
| Novo Nordisk Investigational Site | Marietta | Georgia | 30067 | United States |
| Novo Nordisk Investigational Site | Idaho Falls | Idaho | 83404-7596 | United States |
| Novo Nordisk Investigational Site | Chicago | Illinois | 60607 | United States |
| Novo Nordisk Investigational Site | Lexington | Kentucky | 40504-2681 | United States |
| Novo Nordisk Investigational Site | Buffalo | New York | 14209 | United States |
| Novo Nordisk Investigational Site | Asheville | North Carolina | 28803 | United States |
| Novo Nordisk Investigational Site | Canton | Ohio | 44708 | United States |
| Novo Nordisk Investigational Site | Columbus | Ohio | 43203 | United States |
| Novo Nordisk Investigational Site | Medford | Oregon | 97504 | United States |
| Novo Nordisk Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| Novo Nordisk Investigational Site | Greer | South Carolina | 29651 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75230 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75231 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75246 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75390-8858 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77030 | United States |
| Novo Nordisk Investigational Site | Midland | Texas | 79707 | United States |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78229 | United States |
| Novo Nordisk Investigational Site | Warrenton | Virginia | 20186 | United States |
| Novo Nordisk Investigational Site | Renton | Washington | 98055 | United States |
| 16249569 | Result | Raskin P. Initiation of insulin therapy in patients with type 2 diabetes failing oral therapy: response to Mikhail and Cope and to Janka. Diabetes Care. 2005 Nov;28(11):2811. doi: 10.2337/diacare.28.11.2811. No abstract available. |
| 17286868 | Result | Brod M, Cobden D, Lammert M, Bushnell D, Raskin P. Examining correlates of treatment satisfaction for injectable insulin in type 2 diabetes: lessons learned from a clinical trial comparing biphasic and basal analogues. Health Qual Life Outcomes. 2007 Feb 7;5:8. doi: 10.1186/1477-7525-5-8. |
| 17199725 | Result | Ray JA, Valentine WJ, Roze S, Nicklasson L, Cobden D, Raskin P, Garber A, Palmer AJ. Insulin therapy in type 2 diabetes patients failing oral agents: cost-effectiveness of biphasic insulin aspart 70/30 vs. insulin glargine in the US. Diabetes Obes Metab. 2007 Jan;9(1):103-13. doi: 10.1111/j.1463-1326.2006.00581.x. |
| 17223044 | Result | Raskin PR, Hollander PA, Lewin A, Gabbay RA, Bode B, Garber AJ; INITIATE Study Group. Basal insulin or premix analogue therapy in type 2 diabetes patients. Eur J Intern Med. 2007 Jan;18(1):56-62. doi: 10.1016/j.ejim.2006.09.006. |
| 16368057 | Result | Valentine WJ, Palmer AJ, Lammert M, Nicklasson L, Foos V, Roze S. Long-term clinical and cost outcomes of treatment with biphasic insulin aspart 30/70 versus insulin glargine in insulin naive type 2 diabetes patients: cost-effectiveness analysis in the UK setting. Curr Med Res Opin. 2005 Dec;21(12):2063-71. doi: 10.1185/030079905X74989. |
| 18479280 | Result | Goodall G, Jendle JH, Valentine WJ, Munro V, Brandt AB, Ray JA, Roze S, Foos V, Palmer AJ. Biphasic insulin aspart 70/30 vs. insulin glargine in insulin naive type 2 diabetes patients: modelling the long-term health economic implications in a Swedish setting. Int J Clin Pract. 2008 Jun;62(6):869-76. doi: 10.1111/j.1742-1241.2008.01766.x. |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
| D000069036 | Insulin Glargine |
| D008687 | Metformin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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