Comparison of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.
Overview[ - collapse ][ - ]
| Purpose | This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of Insulin glargine versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in combination with metformin in subjects with Type 2 Diabetes. |
|---|---|
| Condition | Diabetes Diabetes Mellitus, Type 2 |
| Intervention | Drug: biphasic insulin aspart Drug: insulin glargine Drug: metformin |
| Phase | Phase 4 |
| Sponsor | Novo Nordisk A/S |
| Responsible Party | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier | NCT00184626 |
| First Received | September 12, 2005 |
| Last Updated | June 15, 2012 |
| Last verified | June 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 12, 2005 |
|---|---|
| Last Updated Date | June 15, 2012 |
| Start Date | September 2004 |
| Estimated Primary Completion Date | October 2005 |
| Current Primary Outcome Measures | HbA1c [Time Frame: Measured at end of treatment (26 weeks)] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Comparison of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes. |
|---|---|
| Official Title | Safety and Efficacy of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes. |
| Brief Summary | This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of Insulin glargine versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in combination with metformin in subjects with 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 |
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| Intervention | Drug: biphasic insulin aspart Drug: insulin glargine Drug: metformin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 97 |
| Estimated Completion Date | October 2005 |
| Estimated Primary Completion Date | October 2005 |
| Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes - Body mass index equal to or lesser than 35.0 kg/m2 - Currently treated with oral hypoglycaemic drug Exclusion Criteria: - Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator - Any condition that the Investigator and/or the Sponsor feel would interfere with trial participation or evaluation of results |
| Gender | Both |
| Ages | 35 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Turkey |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00184626 |
|---|---|
| Other Study ID Numbers | BIASP-1594 |
| Has Data Monitoring Committee | No |
| Information Provided By | Novo Nordisk A/S |
| Study Sponsor | Novo Nordisk A/S |
| Collaborators | Not Provided |
| Investigators | Study Director: Sebnem A. Tuna, MD Novo Nordisk Saglik Ürünleri Tic. Ltd. Sti. |
| Verification Date | June 2012 |
Locations[ + expand ][ + ]
| Turkey | Istanbul, Turkey |
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