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

NCT ID: NCT02333851

Last Updated: 2015-01-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-02-28

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.

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Premixed insulin

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

Group Type: EXPERIMENTAL

Mixtard 30:70 Novonordisk® twice daily

Intervention Type: DRUG

Premixed insulin twice daily before breakfast and before dinner

Basal-bolus

'Lantus® once daily and Apidra® before meals

Group Type: EXPERIMENTAL

Lantus® once daily and Apidra® before meals

Intervention Type: DRUG

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

Interventions

Mixtard 30:70 Novonordisk® twice daily

Premixed insulin twice daily before breakfast and before dinner

Intervention Type: DRUG

Lantus® once daily and Apidra® before meals

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

Intervention Type: DRUG

Other Intervention Names

Premixed 30:70 insulin two times a day; Basal bolus regimen

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Hospital Universitario Central de Asturias

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edelmiro Menéndez Torre

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Central de Asturias

Other Identifiers

ENDOHUCA1

Identifier Type: -

Identifier Source: org_study_id