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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University Hospital Hradec Kralove.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital Hradec Kralove
ClinicalTrials.gov Identifier:
NCT01088451
First received: February 11, 2010
Last updated: March 16, 2010
Last verified: February 2010
History of Changes
  Purpose

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 Intervention
Diabetes Mellitus, Type 1
 Drug: Combined prandial insulin therapy (CPIT)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Joint Application of Human Insulin and Rapid Insulin Analogue in Control of Postprandial Glycemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Hradec Kralove:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   12 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088451

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

Publications:

Responsible Party: David Neumann/Principal Investigator, University Hospital Hradec Králové
ClinicalTrials.gov Identifier: NCT01088451     History of Changes
Other Study ID Numbers: 200912S24, MZO00179906-01
Study First Received: February 11, 2010
Last Updated: March 16, 2010
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by University Hospital Hradec Kralove:
Diabetes Mellitus, Type 1
Prandial Glycemia
Rapid Acting Insulin Analogue
Human Insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013