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Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes

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: NCT00698802
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE June 16, 2008
First Posted Date  ICMJE June 17, 2008
Last Update Posted Date April 14, 2015
Study Start Date  ICMJE June 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
HbA1c [ Time Frame: after 8 weeks of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
  • HbA1c [ Time Frame: For the duration of the trial ]
  • Fructosamine [ Time Frame: For the duration of the trial ]
  • FPG [ Time Frame: For the duration of the trial ]
  • 4-point SMPG profiles [ Time Frame: For the duration of the trial ]
  • Incidence of hypoglycaemic episodes [ Time Frame: For the duration of the trial ]
  • Frequency and severity of adverse events (including injection site reactions) [ Time Frame: For the duration of the trial ]
  • Laboratory safety parameters (haematology, biochemistry and lipids) [ Time Frame: For the duration of the trial ]
  • Physical examination and vital signs [ Time Frame: For the duration of the trial ]
  • Total daily insulin dosages [ Time Frame: For the duration of the trial ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes
Official Title  ICMJE Assessment of Safety and Efficacy of Biphasic Human Insulin IU 100 to EX1000 on Glycaemic Control in Subjects With Type 2 Diabetes
Brief Summary This trial is conducted in Asia and Africa. This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
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: EX1000
    Treat-to-target titration scheme, s.c. injection
  • Drug: biphasic human insulin
    Treat-to-target titration scheme, s.c. injection
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: EX1000
  • Active Comparator: B
    Intervention: Drug: biphasic human insulin
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: March 25, 2009)
397
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2008)
400
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 2 diabetes for at least 12 months
  • Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs
  • Body Mass Index (BMI) less than or equal to 40.0 kg/m2
  • HbA1c less than or equal to 9.5%
  • FPG (SMPG) less than or equal to 12 mmol/L

Exclusion Criteria:

  • Treatment with more than 1IU/kg insulin daily
  • Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
  • Known or suspected allergy to trial products or related products
  • Receipt of any investigational drug within one month prior to this trial
  • Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
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 India,   South Africa,   United Arab Emirates
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00698802
Other Study ID Numbers  ICMJE EX1000-1919
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 April 2015

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