Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin
Overview[ - collapse ][ - ]
Purpose | This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin. |
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Condition | Diabetes Diabetes Mellitus, Type 2 |
Intervention | Drug: biphasic insulin aspart 30 Drug: metformin |
Phase | Phase 4 |
Sponsor | Novo Nordisk A/S |
Responsible Party | Novo Nordisk A/S |
ClinicalTrials.gov Identifier | NCT00669864 |
First Received | April 29, 2008 |
Last Updated | June 5, 2012 |
Last verified | June 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | April 29, 2008 |
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Last Updated Date | June 5, 2012 |
Start Date | November 2007 |
Estimated Primary Completion Date | April 2009 |
Current Primary Outcome Measures | Change in HbA1c (Glycosylated Haemoglobin A1c) [Time Frame: week 0, week 16] [Designated as safety issue: No]Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment) |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin |
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Official Title | Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin |
Brief Summary | This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: biphasic insulin aspart 30 Subcutaneous (under the skin) injection, twice daily Other Names: NovoMix® 30Drug: metformin Tablets, 1000 - 2000 mg daily |
Study Arm (s) | Experimental: BIAsp 30-30 Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 293 |
Estimated Completion Date | April 2009 |
Estimated Primary Completion Date | April 2009 |
Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes - Currently treated with basal insulin once or twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months - HbA1c (glycosylated haemoglobin A1c) within the range of 7.5% to10.0% ( both inclusive) - BMI (Body Mass Index) maximum 40 kg/m2 Exclusion Criteria: - Metformin contraindications according to local practice - Systemically treated with TZDs (thiazolidinediones) for more than one month within 6 months prior to this trial |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | China |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00669864 |
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Other Study ID Numbers | BIASP-1960 |
Has Data Monitoring Committee | No |
Information Provided By | Novo Nordisk A/S |
Study Sponsor | Novo Nordisk A/S |
Collaborators | Not Provided |
Investigators | Study Director: Ruifang LIANG Novo Nordisk A/SStudy Director: HONGFEI XU Novo Nordisk A/S |
Verification Date | June 2012 |
Locations[ + expand ][ + ]
China, Beijing | Beijing, Beijing, China, 100034 |
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