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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Terminated

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Mixtard 30:70 Novonordisk® twice daily

Lantus® once daily and Apidra® before meals

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes mellitus treatment, Hospitalized patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Premixed insulin

Basal-bolus

Arm Description

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

'Lantus® once daily and Apidra® before meals

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number and severity of hypoglycemia episodes

Frequency and severity of hypoglycemia episodes during all the stay in the hospital

Measures of dispersion of glycemia values (Glycemia variability)

Glycemia variability will be measured by standard deviation of blood glucose values, coefficient of variation and mean amplitude of glycemic excursions or MAGE.

Total daily Insulin use in International Units per Kg of weight

Full Information

NCT ID

NCT02333851

First Posted

December 20, 2014

Last Updated

January 5, 2015

Sponsor

Hospital Universitario Central de Asturias

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02333851

Brief Title

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

Acronym

PININ

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Terminated

Why Stopped

Safety reasons

Study Start Date

June 2013 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital Universitario Central de Asturias

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus treatment, Hospitalized patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Premixed insulin

Arm Type

Experimental

Arm Description

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

Arm Title

Basal-bolus

Arm Type

Experimental

Arm Description

'Lantus® once daily and Apidra® before meals

Intervention Type

Drug

Intervention Name(s)

Mixtard 30:70 Novonordisk® twice daily

Other Intervention Name(s)

Premixed 30:70 insulin two times a day

Intervention Description

Premixed insulin twice daily before breakfast and before dinner

Intervention Type

Drug

Intervention Name(s)

Lantus® once daily and Apidra® before meals

Other Intervention Name(s)

Basal bolus regimen

Intervention Description

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

Primary Outcome Measure Information:

Title

Differences in mean daily blood glucose concentration

Description

Glucose concentration were measured in capillary blood 6 times a day, before and 2 hours after meals and daily mean calculated

Time Frame

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

Secondary Outcome Measure Information:

Title

Number and severity of hypoglycemia episodes

Description

Frequency and severity of hypoglycemia episodes during all the stay in the hospital

Time Frame

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

Title

Measures of dispersion of glycemia values (Glycemia variability)

Description

Glycemia variability will be measured by standard deviation of blood glucose values, coefficient of variation and mean amplitude of glycemic excursions or MAGE.

Time Frame

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edelmiro Menéndez Torre

Organizational Affiliation

Hospital Universitario Central de Asturias

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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