Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | This trial is conducted in Europe. The aim of this trial is to investigate the efficacy on blood glucose control in type 2 diabetes. |
|---|---|
| Condition | Diabetes Diabetes Mellitus, Type 2 |
| Intervention | Drug: biphasic insulin aspart Drug: insulin glargine Drug: metformin Drug: glimepiride |
| Phase | Phase 4 |
| Sponsor | Novo Nordisk A/S |
| Responsible Party | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier | NCT00619697 |
| First Received | February 11, 2008 |
| Last Updated | June 15, 2012 |
| Last verified | June 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 11, 2008 |
|---|---|
| Last Updated Date | June 15, 2012 |
| Start Date | December 2003 |
| Estimated Primary Completion Date | March 2005 |
| Current Primary Outcome Measures | HbA1c [Time Frame: after 26 weeks of treatment] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes |
|---|---|
| Official Title | Comparison of Efficacy and Safety of Biphasic Insulin Aspart 30 Plus Metformin With Insulin Glargine Plus Glimepiride in Type 2 Diabetes |
| Brief Summary | This trial is conducted in Europe. The aim of this trial is to investigate the efficacy on blood glucose control in type 2 diabetes. |
| 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 Other Names:
Drug: metformin Drug: glimepiride |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 260 |
| Estimated Completion Date | March 2005 |
| Estimated Primary Completion Date | March 2005 |
| Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes for at least 6 months - Insulin naive. Short term insulin treatment (7 days or less within the last 6 months) is allowed - Previous treatment with oral antidiabetic drugs for at least 4 months - Judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen - BMI below 40 kg/m2 - HbA1c between 7-12% - Able and willing to perform self-plasma glucose monitoring Exclusion Criteria: - The receipt of any other investigational drug within 4 weeks before screening - A history of drug or alcohol abuse within the last 12 months - Severe, uncontrolled hypertension - Known or suspected allergy to trial products or related products |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Austria, Czech Republic, Germany, Hungary, Poland, Slovakia, Slovenia |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00619697 |
|---|---|
| Other Study ID Numbers | BIASP-1564 |
| 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 ][ + ]
| Austria | Graz, Austria, 8036 |
|---|---|
| Czech Republic | Brno, Czech Republic, 65691 |
| Germany | Marburg, Germany, 35043 |
| Hungary | Budapest, Hungary, 1041 |
| Poland | Otwock, Poland, 05-400 |
| Slovakia | Martin, Slovakia, 036 59 |
| Slovenia | Ljubljana, Slovenia, 1000 |