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Joint Application of Human Insulin and Rapid Insulin Analogue in Control of Postprandial Glycemia (CPIT)

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ClinicalTrials.gov Identifier: NCT01088451
Recruitment Status : Unknown
Verified February 2010 by University Hospital Hradec Kralove.
Recruitment status was:  Active, not recruiting
First Posted : March 17, 2010
Last Update Posted : March 17, 2010
Sponsor:
Information provided by:
University Hospital Hradec Kralove

Tracking Information
First Submitted Date  ICMJE February 11, 2010
First Posted Date  ICMJE March 17, 2010
Last Update Posted Date March 17, 2010
Study Start Date  ICMJE December 2009
Estimated Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2010)
Differences in mean blood glucose concentrations and the pattern of fluctuation on control and study days; and changes in the glycated hemoglobin A1c after the study period. Occurrence of side effects especially hypoglycemic episodes. [ Time Frame: one month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2010)
The difference in postprandial areas under the curve when comparing conventional therapy and experimental combined prandial insulin therapy in the 5 to 6 hours following meal ingestion, taking into account the glycemic index profile of the meal. [ Time Frame: one month ]
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 Joint Application of Human Insulin and Rapid Insulin Analogue in Control of Postprandial Glycemia
Official Title  ICMJE Joint Application of Human Insulin and Rapid Insulin Analogue in Control of Postprandial Glycemia
Brief Summary

Postprandial glycemic control is essential for diabetes compensation. Insulin pump therapy control blood glucose released in response to both high and low glycemic index carbohydrates in a mixed diet using normal, square and dual-wave boluses. The investigators hypothesize a mixture of rapid insulin analogue and human insulin has the same effect.

This pilot prospective cohort study replaces basal-bolus therapy of diabetic subjects by combined prandial application of insulin aspart and human insulin. Mixed-meals with high, both high and low and low glycemic index carbohydrates are covered by 3:1, 1:1 and 1:3 ratios of analogue to human insulin mixture. Subjects are followed by continuous glucose monitor for six days (Phase One), changing between the experimental or their standard protocol for insulin injection on consecutive days. The outcome was measured by comparing average glycemia and areas under the curve of sample meals, which are doughnut, pizza and mixed vegetable salad. The next three-to-four week period of therapy was evaluated by glycated hemoglobin before and after the intervention (Phase Two).

Expected outcomes are postprandial and complex improvement of diabetes control, similarly to the insulin pump therapy.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE Drug: Combined prandial insulin therapy (CPIT)
Combined prandial insulin therapy (CPIT) applies individual combination of rapid insulin analogue and human insulin according subject's individual estimation of the type of carbohydrates in concrete mixed-meal, based on thorough education. In this study subjects use two applicators, giving two injections before main meals as per basal-bolus therapy. Insulin aspart (Novorapid, Novo Nordisk) and human insulin (Actrapid, Novo Nordisk) are used.
Study Arms  ICMJE Not Provided
Publications *

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 16, 2010)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2010
Estimated Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  • pubertal children, adolescents, young adults able to follow instructions, regardless of their long-time compliance
  • willing to undertake a prandial application of two kinds of insulin using two standard insulin applicators.
  • willing to complete detailed meal, insulin and/or combination insulin and hypoglycemia diary throughout the study.

Exclusion criteria:

  • acute illness and celiac disease, but not euthyroid autoimmune thyroiditis, defined as thyroid stimulating hormone (TSH)<4 mIU/l.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01088451
Other Study ID Numbers  ICMJE 200912S24
MZO00179906-01 ( Other Grant/Funding Number: University Hospital Hradec Králové )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Neumann/Principal Investigator, University Hospital Hradec Králové
Study Sponsor  ICMJE University Hospital Hradec Kralove
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital Hradec Kralove
Verification Date February 2010

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