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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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ClinicalTrials.gov Identifier: NCT00669864
Recruitment Status : Completed
First Posted : May 1, 2008
Results First Posted : July 5, 2010
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE April 29, 2008
First Posted Date  ICMJE May 1, 2008
Results First Submitted Date  ICMJE April 29, 2010
Results First Posted Date  ICMJE July 5, 2010
Last Update Posted Date April 1, 2016
Study Start Date  ICMJE November 2007
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2010)
Change in HbA1c (Glycosylated Haemoglobin A1c) [ Time Frame: week 0, week 16 ]
Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2008)
HbA1c change from baseline [ Time Frame: after 16 weeks ]
Change History Complete list of historical versions of study NCT00669864 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2010)
  • Change in 8-point Plasma Glucose Profile [ Time Frame: week 0, week 16 ]
    Summary of change in 8-point plasma glucose profile by week and time. The 8 time points measured were: Before each meal (breakfast, lunch and dinner), at 2 hours after each meal (breakfast, lunch and dinner), at bedtime, and at 3 AM, measured over 16 weeks of treatment
  • Percentage of Subjects Achieving HbA1c Less Than 7.0% [ Time Frame: week 16 ]
    Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below 7.0% after 16 weeks of treatment
  • Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% [ Time Frame: week 16 ]
    Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below or equal to 6.5% after 16 weeks of treatment
  • Hypoglycaemic Episodes [ Time Frame: weeks 0-16 ]
    Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment). Hypoglycaemic episodes were defined 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 plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.
  • Hypoglycaemic Episodes, Diurnal/Nocturnal [ Time Frame: weeks 0-16 ]
    Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment) during the day (diurnal) and the night (nocturnal).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2008)
  • 8-point plasma glucose profile [ Time Frame: at 16 weeks ]
  • Percentage of Subjects Achieving HbA1c Less Than 7.0% [ Time Frame: at 16 weeks ]
  • Percentage of subjects achieving HbA1c equal or below 6.5% [ Time Frame: at 16 weeks ]
  • Safety profile [ Time Frame: during treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: biphasic insulin aspart 30
    Subcutaneous (under the skin) injection, twice daily
    Other Name: NovoMix® 30
  • Drug: metformin
    Tablets, 1000 - 2000 mg daily
Study Arms  ICMJE 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
Interventions:
  • Drug: biphasic insulin aspart 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: April 29, 2009)
293
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2008)
660
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT00669864
Other Study ID Numbers  ICMJE BIASP-1960
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 March 2016

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