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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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ClinicalTrials.gov Identifier: NCT00807092
Recruitment Status : Completed
First Posted : December 11, 2008
Results First Posted : April 11, 2011
Last Update Posted : March 4, 2015
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE December 10, 2008
First Posted Date  ICMJE December 11, 2008
Results First Submitted Date  ICMJE November 12, 2010
Results First Posted Date  ICMJE April 11, 2011
Last Update Posted Date March 4, 2015
Study Start Date  ICMJE December 2008
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2011)
Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals [ Time Frame: Week 0, week 6 ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 10, 2008)
Mean IAUC for postprandial glucose (0-4 hours) over 3 main meals assessed by CGMS [ Time Frame: After 6 weeks ]
Change History Complete list of historical versions of study NCT00807092 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2011)
  • Change in Mean IAUC for Postprandial Glucose (0-4 Hours) After Each Meal (Breakfast, Lunch, Dinner) Assessed by CGMS [ Time Frame: Week 0, Week 6 ]
    The blood glucose profiles were monitored by CGMS for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC (0-4 hours) after each meal at 6 weeks and change in IAUC (0-4 hours) from baseline (week 0) after each meal were to be assessed. The arithmetic mean of day 1 and day 2 for each meal-specific incremental area (breakfast, lunch, dinner) was calculated.
  • Mean FBG (Fasting Blood Glucose) Assessed by CGMS [ Time Frame: Week 6 ]
    The blood glucose profiles were monitored by CGMS for 72 hours at end of treatment (week 6). Mean FBG assessed by CGMS at 6 weeks. FBG was read on the CGMS glucose curves at 06:00 each morning over the 72 hours. The arithmetic mean of day 1 and day 2 was used as the value of mean FBG for each CGMS period.
  • Change in Mean FBG Assessed by CGMS [ Time Frame: Week 0, week 6 ]
    The blood glucose profiles were monitored by CGMS for 72 hours at baseline (week 0) and at end of treatment (week 6). Change in mean FBG from baseline (week 0) was assessed. FBG was read on the CGMS glucose curves at 06:00 each morning over the 72 hours. The arithmetic mean of day 1 and day 2 was used as the value of mean FBG for each CGMS period.
  • Change in FPG (Fasting Plasma Glucose) [ Time Frame: Week 0, Week 6 ]
    FPG was analysed by local laboratories at baseline (week 0) and end of treatment (week 6). Change in FPG at end of treatment (week 6) from baseline (week 0) was to be assessed.
  • Change in 8-point SMBG (Self-monitored Blood Glucose) Profiles [ Time Frame: Week 0, Week 6 ]
    Subjects were asked to perform 8-point SMBG profiles using the provided blood glucose meter on one day within 72 hours CGMS monitoring period at week 0 and week 6. Change in blood glucose level at end of treatment (week 6) from baseline (week 0) at each time point was to be assessed respectively. Blood glucose levels were measured at the following 8 time points: Before each meal (breakfast, lunch and dinner), 120 minutes after the start of each meal, at bedtime and at 3 am in the morning.
  • Change in Prandial Blood Glucose Increment [ Time Frame: Week 0, Week 6 ]
    Subjects were asked to perform 8-point SMBG profiles using the provided blood glucose meter on one day within 72 hours CGMS monitoring period at week 0 and week 6 respectively. Prandial increment was the difference between the blood glucose (BG) value measured 120 minutes after meal and the BG value measured before meal.
  • Change in MAGE (Mean Amplitude of Glycaemic Excursions) Assessed by CGMS [ Time Frame: Week 0, Week 6 ]
    MAGE is a parameter to monitor the intraday blood glucose excursions. It was calculated using CGMS data and as the arithmetic mean of glycaemic excursion with the criterion that both segments (ascending and descending parts) of the glycaemic excursion exceed of the value of one standard deviation of respective 24-hour blood glucose value. The direction of calculation (peak-to-nadir or nadir-to-peak) was established by the direction of the first excursion. The arithmetic mean of the glycaemic excursion of day 1 and day 2 was the value of MAGE for each CGMS
  • Change in GA (Glycated Albumin) [ Time Frame: Week -2, week 6 ]
    Glycated Albumin is used as a general glycaemic control parameter. Analysed by laboratory. GA was measured at baseline (week 0) and end of treatment (week 6). Change in GA at end of treatment (week 6) from baseline (week 0) was assessed.
  • Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week -2, week 6 ]
  • Duration of Hypoglycaemic Events Based on CGMS [ Time Frame: 72-hour monitoring period at Week 0 and Week 6 ]
    The CGMS device recorded blood glucose levels every 10 seconds then stored a smoothed average over 5 minutes. The range of blood glucose detection was 2.2-22 mmol/l. Hypoglycaemia was defined as blood glucose readings below 3.5 mmol/l or below 2.5 mmol/l, respectively. The duration of the hypoglycaemic episodes was quantified by accumulating the total time the CGMS profiles stays below the defined threshold (i.e. below 3.5 mmol/l or below 2.5 mmol/l, respectively).
  • Hypoglycaemia Based on Self-reported Episodes [ Time Frame: Weeks 0-6 ]
    Total number of hypoglycaemic episodes occurring in the trial after baseline (week 0) until the end of treatment (week 6). Hypoglycaemic episodes are classified as major, minor or symptoms only: Major if the subject was unable to treat her/himself; minor if subject was able to treat her/himself and self monitored blood glucose (SMBG) was below 2.8 mmol/L; symptoms only if subject was able to treat her/himself and with no blood glucose measurement or SMBG higher than or equal to 2.8 mmol/L.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2008)
  • IAUC for postprandial glucose (0-4 hours) after each meal (breakfast, lunch, dinner) assessed by CGMS [ Time Frame: after 6 weeks ]
  • FBG (Fasting blood glucose) assessed by CGMS (continuous glucose monitoring system ) [ Time Frame: after 6 weeks ]
  • FPG (Fasting plasma glucose) assessed by local laboratories [ Time Frame: after 6 weeks ]
  • 8-point SMBG (self-monitored blood glucose) profiles [ Time Frame: after 6 weeks ]
  • MAGE (mean amplitude of glycaemic excursions) assessed by CGMS [ Time Frame: after 6 weeks ]
  • GA (Glycated albumin) assessed by central laboratory [ Time Frame: after 6 weeks ]
  • HbA1c assessed by central laboratory [ Time Frame: after 6 weeks ]
  • Safety profiles during treatment period [ Time Frame: during treatment period. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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 Arms  ICMJE
  • Experimental: BIAsp 30
    BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
    Interventions:
    • Drug: biphasic insulin aspart 30
    • Drug: metformin
  • Experimental: BHI 30
    BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
    Interventions:
    • Drug: biphasic human insulin 30
    • Drug: metformin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2015)
145
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2008)
128
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00807092
Other Study ID Numbers  ICMJE BIASP-3681
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP