Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Diabetes Diabetes Mellitus, Type 2 |
| Intervention | Drug: biphasic insulin aspart Drug: insulin glargine Drug: metformin Drug: pioglitazone |
| Phase | Phase 4 |
| Sponsor | Novo Nordisk A/S |
| Responsible Party | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier | NCT00598793 |
| First Received | January 11, 2008 |
| Last Updated | June 5, 2012 |
| Last verified | June 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 11, 2008 |
|---|---|
| Last Updated Date | June 5, 2012 |
| Start Date | November 2002 |
| Estimated Primary Completion Date | March 2004 |
| Current Primary Outcome Measures | HbA1c [Time Frame: after 28 weeks of treatment] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy |
|---|---|
| Official Title | Biphasic Insulin Aspart 70/30 + Metformin Compared to Insulin Glargine + Metformin in Type 2 Diabetes Failing OAD Therapy |
| Brief Summary | 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: biphasic insulin aspart Drug: insulin glargine Drug: metformin Drug: pioglitazone |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 242 |
| Estimated Completion Date | March 2004 |
| Estimated Primary Completion Date | March 2004 |
| Eligibility Criteria | Inclusion Criteria: - Insulin naive Type 2 diabetes - Currently treated with OADs alone or combined with other treatment for at least 3 months - BMI below 40 kg/m2 and body weight below 125 kg - HbA1c greater than or equal to 8% Exclusion Criteria: - Inability to tolerate metformin or contradictions to its use - Pregnant, breastfeeding or intention of becoming pregnant - Allergy to any of the trial products - Inability or unwillingness to perform SMBG |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00598793 |
|---|---|
| Other Study ID Numbers | BIASP-2163 |
| Has Data Monitoring Committee | No |
| Information Provided By | Novo Nordisk A/S |
| Study Sponsor | Novo Nordisk A/S |
| Collaborators | Not Provided |
| Investigators | Study Director: Plamen Kozlovski Novo Nordisk A/S |
| Verification Date | June 2012 |
Locations[ + expand ][ + ]
| Novo Nordisk Clinical Trial Call Center | Concord, California, United States, 94520 |
|---|---|
| Novo Nordisk Clinical Trial Call Center | Los Angeles, California, United States, 90057 |
| Novo Nordisk Clinical Trial Call Center | Walnut Creek, California, United States, 94598 |
| Novo Nordisk Clinical Trial Call Center | Melbourne, Florida, United States, 32935 |
| Novo Nordisk Clinical Trial Call Center | Melbourne, Florida, United States, 32901 |
| Novo Nordisk Clinical Trial Call Center | West Palm Beach, Florida, United States, 33401 |
| Novo Nordisk Clinical Trial Call Center | Atlanta, Georgia, United States, 30309 |
| Novo Nordisk Clinical Trial Call Center | Idaho Falls, Idaho, United States, 83404-7542 |
| Novo Nordisk Clinical Trial Call Center | Chicago, Illinois, United States, 60607 |
| Novo Nordisk Clinical Trial Call Center | Lexington, Kentucky, United States, 40504-2681 |
| Novo Nordisk Clinical Trial Call Center | Buffalo, New York, United States, 14209 |
| Novo Nordisk Clinical Trial Call Center | Asheville, North Carolina, United States, 28801 |
| Novo Nordisk Clinical Trial Call Center | Canton, Ohio, United States, 44708 |
| Novo Nordisk Clinical Trial Call Center | Columbus, Ohio, United States, 43203 |
| Novo Nordisk Clinical Trial Call Center | Medford, Oregon, United States, 97504 |
| Novo Nordisk Clinical Trial Call Center | Hershey, Pennsylvania, United States, 17033 |
| Novo Nordisk Clinical Trial Call Center | Greer, South Carolina, United States, 29651 |
| Novo Nordisk Clinical Trial Call Center | Dallas, Texas, United States, 75230 |
| Novo Nordisk Clinical Trial Call Center | Dallas, Texas, United States, 75246 |
| Novo Nordisk Clinical Trial Call Center | Dallas, Texas, United States, 75231 |
| Novo Nordisk Clinical Trial Call Center | Dallas, Texas, United States, 75390-8858 |
| Novo Nordisk Clinical Trial Call Center | Houston, Texas, United States, 77030 |
| Novo Nordisk Clinical Trial Call Center | Midland, Texas, United States, 79707 |
| Novo Nordisk Clinical Trial Call Center | San Antonio, Texas, United States, 78229 |
| Novo Nordisk Clinical Trial Call Center | Warrenton, Virginia, United States, 20186 |
| Novo Nordisk Clinical Trial Call Center | Renton, Washington, United States, 98055 |