Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | This trial is conducted in Europe. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different premixed insulin analogues given in combination with an oral anti-diabetic drug. |
|---|---|
| Condition | Diabetes Diabetes Mellitus, Type 2 |
| Intervention | Drug: biphasic insulin aspart Drug: metformin |
| Phase | Phase 3 |
| Sponsor | Novo Nordisk A/S |
| Responsible Party | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier | NCT00184574 |
| First Received | September 12, 2005 |
| Last Updated | October 18, 2013 |
| Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 12, 2005 |
|---|---|
| Last Updated Date | October 18, 2013 |
| Start Date | April 2005 |
| Estimated Primary Completion Date | March 2006 |
| Current Primary Outcome Measures | HbA1c [Time Frame: after 36 weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 Diabetes |
|---|---|
| Official Title | Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30, Biphasic Insulin Aspart 50/50, and Biphasic Insulin Aspart 30/70 All in Combination With Metformin in Subjects With Type 2 Diabetes (the INTENSIMIX Trial). |
| Brief Summary | This trial is conducted in Europe. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different premixed insulin analogues given in combination with an oral anti-diabetic drug. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: biphasic insulin aspart Drug: metformin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 603 |
| Estimated Completion Date | March 2006 |
| Estimated Primary Completion Date | March 2006 |
| Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes - Currently treated with insulin - Currently treated with Metformin - HbA1c: 7.5-12.0% Exclusion Criteria: - Body Mass Index (BMI) < 25.0 or > 40.0 kg/m2 - Metformin contraindications according to local practice - TZDs within 6 months prior to randomisation |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Russian Federation, Slovenia, Spain, Switzerland, Turkey, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00184574 |
|---|---|
| Other Study ID Numbers | BIASP-1440 |
| Has Data Monitoring Committee | No |
| Information Provided By | Novo Nordisk A/S |
| Study Sponsor | Novo Nordisk A/S |
| Collaborators | Not Provided |
| Investigators | Study Director: Malene B. Krüger Novo Nordisk A/S |
| Verification Date | October 2013 |
Locations[ + expand ][ + ]
| Austria | Wien, Austria, A-1130 |
|---|---|
| Belgium | Gent, Belgium |
| Bulgaria | Sofia, Bulgaria, 1431 |
| Czech Republic | Hradec Králové, Czech Republic, 500 36 |
| Denmark | Århus C, Denmark, 8000 |
| France | Lille, France, 59037 |
| Germany | Bad Heilbrunn, Germany, 83670 |
| Hungary | Budapest, Hungary, 1125 |
| Italy | Catania, Italy, 95126 |
| Netherlands | Rotterdam, Netherlands, 3011 TD |
| Poland | Zabrze, Poland |
| Romania | Suceava, Romania, 720062 |
| Russian Federation | Moscow, Russian Federation, 117036 |
| Slovenia | Ljubljana, Slovenia, 1000 |
| Spain | Madrid, Spain, 28040 |
| Switzerland | Zürich, Switzerland, 8002 |
| Turkey | Istanbul, Turkey, 34098 |
| United Kingdom | Sheffield, United Kingdom, S5 7AU |