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

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ClinicalTrials.gov Identifier: NCT02333851
Recruitment Status : Terminated (Safety reasons)
First Posted : January 7, 2015
Last Update Posted : January 7, 2015
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Hospital Universitario Central de Asturias

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Mixtard 30:70 Novonordisk® twice daily Drug: Lantus® once daily and Apidra® before meals Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Basal-bolus and Premixed Insulin Regimens in Hospitalized Patients With Type 2 Diabetes (PININ Study)
Study Start Date : June 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Premixed insulin
Mixtard 30:70 Novonordisk® twice daily, before breakfast and before dinner.
 Drug: Mixtard 30:70 Novonordisk® twice daily
Premixed insulin twice daily before breakfast and before dinner
Other Name: Premixed 30:70 insulin two times a day
Experimental: Basal-bolus
'Lantus® once daily and Apidra® before meals
 Drug: Lantus® once daily and Apidra® before meals
Injection of Lantus® insulin once daily and rapid insulin Apidra® before breakfast, lunch and dinner
Other Name: Basal bolus regimen


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02333851


Sponsors and Collaborators
Hospital Universitario Central de Asturias
Sanofi
Investigators
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Principal Investigator: Edelmiro Menéndez Torre Hospital Universitario Central de Asturias
More Information
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Responsible Party: Hospital Universitario Central de Asturias
ClinicalTrials.gov Identifier: NCT02333851    
Other Study ID Numbers: ENDOHUCA1
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: January 7, 2015
Last Verified: January 2015
Keywords provided by Hospital Universitario Central de Asturias:
Type 2 diabetes mellitus treatment
Hospitalized patients
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Insulin, pork; isophane insulin, pork drug combination 30:70
Hypoglycemic Agents
Physiological Effects of Drugs