Basal-bolus and Premixed Insulin Regimens in Hospitalized Patients With Type 2 Diabetes (PININ Study) (PININ)

January 5, 2015 updated by: Hospital Universitario Central de Asturias

Comparison of Basal-bolus and Premixed Insulin Regimens in Hospitalized Patients With Type 2 Diabetes (PININ Study)

Pilot study to compare the efficacy and safety of a premixed-insulin regimen (70% intermediate insulin and 30% regular insulin) to a basal-bolus insulin regimen (glargine once daily and glulisine before meals) hospitalized patients with type 2 diabetes.

Study Overview

Detailed Description

Pilot, randomized, prospective, open-label study admitted to the Hospital with a previous diagnosis of type 2 diabetes or with a blood glucose level on admission greater than 180 mg/dl.

Patients were randomized to receive a premixed human insulin formulation with 70% intermediate insulin plus 30% regular insulin (Mixtard 30®, Novo Nordisk) or a basal-bolus regimen with glargine once daily and glulisine before meals (Lantus® and Apidra®, Sanofi-Aventis).

The primary outcome of the study was to determine differences in glycemic control between treatment groups as measured by mean daily blood glucose concentration during the hospital stay. Secondary objectives were to determine differences in the percentage of glucose measures between 80 and 180 mg/dl, frequency and severity of hypoglycemic events, total daily insulin use, length of hospital stay and glycemic viability between groups.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previous diagnosis of type 2 diabetes with a blood glucose level on admission greater than 180 mg/dl and treated with diet, any combination of oral antidiabetics agents and/or insulin therapy

Exclusion Criteria:

  • Patients with hyperglycemia without a previous diagnosis of diabetes
  • Patients with acute hyperglycemic emergencies or with severe hyperglycemia treated with intravenous insulin infusion on admission
  • Patients with acute or chronic kidney disease (serum creatinine greater than 2 mg/dl),
  • Patients treated with corticosteroids
  • Patients with history of severe or repeated hypoglycemic episodes
  • Pregnant women
  • Patients expected to require ICU admission or less than 3 days of hospital stay

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Premixed insulin
Mixtard 30:70 Novonordisk® twice daily, before breakfast and before dinner.
Premixed insulin twice daily before breakfast and before dinner
Other Names:
  • Premixed 30:70 insulin two times a day
Experimental: Basal-bolus
'Lantus® once daily and Apidra® before meals
Injection of Lantus® insulin once daily and rapid insulin Apidra® before breakfast, lunch and dinner
Other Names:
  • Basal bolus regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in mean daily blood glucose concentration
Time Frame: Participants will be followe for the duration of hospital stay, an expected average of 2 weeks
Glucose concentration were measured in capillary blood 6 times a day, before and 2 hours after meals and daily mean calculated
Participants will be followe for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and severity of hypoglycemia episodes
Time Frame: Participants will be followe for the duration of hospital stay, an expected average of 2 weeks
Frequency and severity of hypoglycemia episodes during all the stay in the hospital
Participants will be followe for the duration of hospital stay, an expected average of 2 weeks
Measures of dispersion of glycemia values (Glycemia variability)
Time Frame: Participants will be followe for the duration of hospital stay, an expected average of 2 weeks
Glycemia variability will be measured by standard deviation of blood glucose values, coefficient of variation and mean amplitude of glycemic excursions or MAGE.
Participants will be followe for the duration of hospital stay, an expected average of 2 weeks
Total daily Insulin use in International Units per Kg of weight
Time Frame: Participants will be followe for the duration of hospital stay, an expected average of 2 weeks
Participants will be followe for the duration of hospital stay, an expected average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Edelmiro Menéndez Torre, Hospital Universitario Central de Asturias

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

December 20, 2014

First Submitted That Met QC Criteria

January 5, 2015

First Posted (Estimate)

January 7, 2015

Study Record Updates

Last Update Posted (Estimate)

January 7, 2015

Last Update Submitted That Met QC Criteria

January 5, 2015

Last Verified

January 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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