Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes
Overview[ - collapse ][ - ]
Purpose | This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to biphasic human insulin 30, both in combination with metformin in Chinese insulin-naive subjects with type 2 diabetes when failing on oral antidiabetic drug (OAD) therapy. |
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Condition | Diabetes Diabetes Mellitus, Type 2 |
Intervention | Drug: biphasic insulin aspart 30 Drug: biphasic human insulin 30 Drug: metformin |
Phase | Phase 4 |
Sponsor | Novo Nordisk A/S |
Responsible Party | Novo Nordisk A/S |
ClinicalTrials.gov Identifier | NCT00807092 |
First Received | December 10, 2008 |
Last Updated | June 15, 2012 |
Last verified | April 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | December 10, 2008 |
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Last Updated Date | June 15, 2012 |
Start Date | December 2008 |
Estimated Primary Completion Date | October 2009 |
Current Primary Outcome Measures | Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals [Time Frame: Week 0, week 6] [Designated as safety issue: No]The blood glucose profiles were monitored by CGMS (Continuous Glucose Monitoring System) for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC was calculated using the trapezoidal method. The arithmetic mean of IAUC (3 meal-specific incremental areas) of day 1 and day 2 was used as the value of IAUC for each CGMS period |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes |
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Official Title | Comparison of the Efficacy on Glycaemic Control and Safety Profile of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 Both in Combination With Metformin in Insulin-naïve Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antidiabetic Drugs (OADs) Therapy |
Brief Summary | This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to biphasic human insulin 30, both in combination with metformin in Chinese insulin-naive subjects with type 2 diabetes when failing on oral antidiabetic drug (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 |
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Intervention | Drug: biphasic insulin aspart 30 The initial doses for BIAsp 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 U/kg body weight and to be equally divided (1/2:1/2) between pre-breakfast and pre-dinner Drug: biphasic human insulin 30 The initial doses for BHI 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 IU/kg body weight and to be divided in the ratio of 2/3:1/3 between pre-breakfast and pre-dinner Drug: metformin Metformin dose must remain the same as that used prior to the trial. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 145 |
Estimated Completion Date | October 2009 |
Estimated Primary Completion Date | October 2009 |
Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes diagnosed for at least 6 months - Insulin-naive (less than or equal to 1 week of daily use of insulin therapy) - Treatment with metformin as monotherapy or in combination therapy with other OAD(s) for at least 3 months prior to this trial - Currently on metformin greater than or equal to 1000 mg/day for at least 2 weeks - Currently at least one of other OAD(s) reaching at least one-half of the recommended maximum dose for at least 2 weeks - Glycosylated haemoglobin (HbA1c) between 7.5-11.0% - Body Mass Index (BMI) between 18.5 - 35.0 kg/m^2 - Be able and willing to perform continuous glucose monitoring system (CGMS ) and self-monitored blood glucose (SMBG) Exclusion Criteria: - Known or suspected allergy to trial product(s) or related products - Any contraindication of metformin - Receipt of investigational drug within the last 3 months prior to this trial - Any history of chronic insulin therapy (more than 1 week of daily use) - Systemically treated with thiazolidinediones (TZDs) for more than one month within 6 months prior to this trial - Pregnancy, nursing mother, or unwillingness to use adequate contraception |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | China |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00807092 |
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Other Study ID Numbers | BIASP-3681 |
Has Data Monitoring Committee | No |
Information Provided By | Novo Nordisk A/S |
Study Sponsor | Novo Nordisk A/S |
Collaborators | Not Provided |
Investigators | Study Director: Cheng Xi, MPhil. Novo Nordisk A/S |
Verification Date | April 2012 |
Locations[ + expand ][ + ]
China, Beijing | Beijing, Beijing, China, 100730 |
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