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Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00755833
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date September 18, 2008
First Posted Date September 19, 2008
Last Update Posted Date October 31, 2016
Study Start Date September 2008
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 2008)
Change in HbA1c [ Time Frame: At 0, 3, 6, 9, 12 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 18, 2008)
  • Percentage of subjects achieving target HbA1c [ Time Frame: At 0, 3, 6, 9, 12 months ]
  • Change in FPG (fasting plasma glucose) [ Time Frame: At 0, 3, 6, 9, 12 months ]
  • Change in PPG (postprandial glucose) [ Time Frame: At 0, 3, 6, 9, 12 months ]
  • Change in number of hypoglycaemic events [ Time Frame: At 0, 3, 6, 9, 12 months ]
  • Change in insulin presentation [ Time Frame: At 0, 3, 6, 9, 12 months ]
  • Dose and number of injections [ Time Frame: At 0, 3, 6, 9, 12 months ]
  • Number of ADRs (adverse drug reaction) [ Time Frame: At 0, 3, 6, 9, 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months
Official Title A Prospective, Multicentre, Open Label, Un-controlled , Observational, 12-month Study in Subjects Using: NovoMix® 50 (Biphasic Insulin Aspart 50) for Treatment of Type 2 Diabetes Mellitus in Slovenia
Brief Summary This study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective is also to observe the different regimes of starting and maintaining the treatment with NovoMix® 50 during one year.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Type 2 diabetes patients from both general and speciality practice settings who have been deemed appropriate to receive NovoMix® 50 as new treatment and as part of routine out-patient care by the prescribing physician.
Condition
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention Drug: biphasic insulin aspart 50
Efficacy and safety data collection in connection with the use of the drug NovoMix® 50 in daily clinical practice.
Other Name: NovoMix® 50
Study Groups/Cohorts A
Intervention: Drug: biphasic insulin aspart 50
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 Completed
Actual Enrollment
 (submitted: August 12, 2014)
270
Original Estimated Enrollment
 (submitted: September 18, 2008)
300
Actual Study Completion Date April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Type 2 diabetes treated with biphasic human insulin with or without metformin
  • Inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the physician's opinion, benefit from treatment with NovoMix® 50

Exclusion Criteria:

  • Subjects with diagnosed type 1 diabetes mellitus
  • Subjects treated with short acting or intermediate acting human insulin or any insulin analogue
  • Subjects who are unlikely to comply with study description, e.g. uncooperative attitude, inability to come for regular visits
  • Subjects with a hypersensitivity to biphasic insulin aspart 50 (NovoMix® 50 )or to any of the excipients
  • Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number NCT00755833
Other Study ID Numbers BIASP-3674
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date October 2016