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Completed

NCT Number: NCT04739241

Premixed vs Basal Bolus Insulin Therapy in Older Patients With Type 2 Diabetes

The purpose of this study is to compare efficacy and security of premixed insulin treatment vs basal bolus insulin treatment in older patients with poorly controlled type 2 diabetes.

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Key information

Conditions

Type 2 Diabetes Treated With Insulin Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatients
  • Age ≥ 65 years old
  • Type 2 diabetes mellitus
  • HbA1c ≥9% (74 mmol/mol)
  • Previously treated with one or two doses of basal insulin and oral hypoglycaemic agents

Exclusion criteria

  • Severe insulin-resistance
  • High doses of corticosteroids
  • Chemotherapy treatment
  • High comorbidity
  • Bad compliance of the treatment
  • Frequent severe hypoglycaemia

Treatment and study plan

premixed insulin therapy

Drug

Premixed insulin treatment: 30% of the calculated dose was administered before breakfast and before lunch (biphasic insulin lispro 50% or biphasic insulin aspart 50%) and the remaining 40% of the dose before dinner (biphasic insulin lispro 25% or biphasic insulin aspart insulin 30%).

basal bolus insulin therapy

Drug

Basal-bolus insulin treatment: 50% dose in insulin glargine and 50% dose in insulin lispro or aspartic, distributed in equal parts in the 3 main meals

Primary outcomes

  1. Change in HbA1c levels

    Time frame: 12 months after recruitment

    Change from baseline in HbA1c levels after 12 months of therapy

Secondary outcomes

  1. Incidence of hypoglycaemia as an adverse effect of the treatment

    Time frame: every month during the 12-month follow-up

    Number of hypoglycaemias by month

  2. Incidence of dosing errors as a measure of the safety of the treatment

    Time frame: every month during the 12-month follow-up

    Number of dosing errors by month

  3. Change in the scores of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) from recruitment to month 12.

    Time frame: 12-month follow-up

    Change from baseline to12 months of therapy using the DTSQ questionnaire of satisfactions with the treatment of diabetes.

  4. Change in the scores of the Diabetes Quality Of Life Questionnaire (EsDQOL) from recruitment to month 12.

    Time frame: 12-month follow-up

    Change from baseline to12 months of therapy using the EsDQOL questionnaire of quality of life in diabetic patients

Sponsors and collaborators

Lead sponsor

Consorci Sanitari Integral

Other

Registry information

Official study title

Is Premixed Insulin Therapy an Alternative to Basal Bolus Therapy in Type 2 Diabetes Mellitus People Older Than 65 Years Old: A Pilot Randomised Trial

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 4, 2021
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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