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

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. 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
Information provided by:
University Hospital Hradec Kralove

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Combined prandial insulin therapy (CPIT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Joint Application of Human Insulin and Rapid Insulin Analogue in Control of Postprandial Glycemia
Study Start Date : December 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01088451

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Czech Republic
University Hospital Hradec Králové
Hradec Králové, Czech Republic, 50005
Sponsors and Collaborators
University Hospital Hradec Kralove

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Responsible Party: David Neumann/Principal Investigator, University Hospital Hradec Králové Identifier: NCT01088451    
Other Study ID Numbers: 200912S24
MZO00179906-01 ( Other Grant/Funding Number: University Hospital Hradec Králové )
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: March 17, 2010
Last Verified: February 2010
Keywords provided by University Hospital Hradec Kralove:
Diabetes Mellitus, Type 1
Prandial Glycemia
Rapid Acting Insulin Analogue
Human Insulin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs