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

NCT02333851 | Terminated Phase 4

• 1 other identifier: ENDOHUCA1
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus treatment; Hospitalized patients

Outcome Measures

Primary Outcomes (1)

• Differences in mean daily blood glucose concentration

  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 Outcomes (3)

• Number and severity of hypoglycemia episodes

  Participants will be followe for the duration of hospital stay, an expected average of 2 weeks

• Measures of dispersion of glycemia values (Glycemia variability)

  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

  Participants will be followe for the duration of hospital stay, an expected average of 2 weeks

Study Arms (2)

Premixed insulin

EXPERIMENTAL

Mixtard 30:70 Novonordisk® twice daily, before breakfast and before dinner.

Drug: Mixtard 30:70 Novonordisk® twice daily

Basal-bolus

EXPERIMENTAL

'Lantus® once daily and Apidra® before meals

Drug: Lantus® once daily and Apidra® before meals

Interventions

Mixtard 30:70 Novonordisk® twice daily DRUG

Premixed insulin twice daily before breakfast and before dinner

Also known as: Premixed 30:70 insulin two times a day

Premixed insulin

Lantus® once daily and Apidra® before meals DRUG

Injection of Lantus® insulin once daily and rapid insulin Apidra® before breakfast, lunch and dinner

Also known as: Basal bolus regimen

Basal-bolus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Central de Asturias: lead
• Sanofi: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin, pork; isophane insulin, pork drug combination 30:70

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Edelmiro Menéndez Torre

  Hospital Universitario Central de Asturias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2014
• First Posted: January 7, 2015
• Study Start: June 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 7, 2015

Record last verified: 2015-01