AzTrials
AzTrials

Diabetes MellitusPhase 4INSUPARNCT02706119

Insulin in Total Parenteral Nutrition

A Phase 4 study testing Subcutaneous glargine insulin and Regular insulin added to TPN bag in people with Diabetes Mellitus, run by Fundación Pública Andaluza Progreso y Salud at 32 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Analyze the level of metabolic control achieved with a routine of regular insulin in the parenteral nutrition (PN) reservoir in addition to subcutaneous glargine insulin, versus only regular insulin in the PN reservoir. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus
What is being tested?
Subcutaneous glargine insulin and Regular insulin added to TPN bag
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
32 sitesSpain
Study dates
1 Jul 2016to 4 Apr 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults (>18 years)
  • Previously diagnosed with diabetes mellitus.
  • Hospitalized but without intensive cares.
  • Have indication of total parenteral nutritional support (TPN, meaning the covering over 70% of the estimated daily requirements intravenously) for a minimum of 5 days.
  • Signature of informed consent.

Who cannot join

  • Diabetes mellitus type 1, diabetes secondary to total pancreatectomy.
  • Patients with intensive cares.
  • Patients who have been prescribed TPN in intensive cares unity more than 48 hours before admission to hospitalization.
  • Intradialytic parenteral nutrition.
  • Patients under 18 or pregnant women.
  • Patients with renal insufficiency stage 3 B (glomerular filtration rate < 45 mL / min).

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Spain32 sites

  • Complejo Hospitalario Universitario de Albacete

    Albacete, 02008

  • Hospital Universitario Principe de Asturias

    Alcalá de Henares, Madrid, 28805

  • Hospital General Mancha Centro

    Alcázar de San Juan, Ciudad Real, 13600

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Universitario Infanta Cristina

    Badajoz, 06080

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitario Bellvitge

    Barcelona, 08907

  • Hospital de Sant Joan Despi Moisès Broggi (Consorci Sanitari Integral)

    Barcelona, 08970

  • Hospital Universitario Reina Sofía

    Córdoba, 14006

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30150

  • Hospital Arquitecto Marcide-Naval

    Ferrol, A Coruña, 15405

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid, 28942

  • Hospital de Cabueñes

    Gijón, Principality of Asturias, 33394

  • Hospital Universitario de Guadalajara

    Guadalajara, 19002

  • Complejo Hospitalario de Jaén

    Jaén, 23008

  • Hospital Universitario Severo Ochoa

    Leganés, Madrid, 28911

  • Complejo Asistencial Universitario de León

    León, 24008

  • Hospital Universitario Gregorio Marañón

    Madrid, 28007

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Regional Universitario de Málaga

    Málaga, 29009

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital de Mérida

    Mérida, Badajoz, 06800

  • Hospital Son Llátzer

    Palma de Mallorca, Balearic Islands, 07198

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Nuestra Señora de la Candelaria

    Santa Cruz de Tenerife, 38010

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: Subcutaneous Versus Intravenous Basal Insulin in Non-critical Hospitalized Diabetic Patients That Receive Total Parenteral Nutrition

Analyze the level of metabolic control achieved with a routine of regular insulin in the parenteral nutrition (PN) reservoir in addition to subcutaneous glargine insulin, versus only regular insulin in the PN reservoir.

Read the detailed description

A pattern of basal insulin (using subcutaneous insulin glargine and regulating the stock as prandial), plus regular subcutaneous insulin as rescue, applied to total parenteral nutrition (TPN) should be as effective (glycemic control, variability) and safe (hypoglycemia) as the usual (regular insulin inside the TPN reservoir and subcutaneous insulin as rescue) in patients with type 2 diabetes critics.

Being tested
Subcutaneous glargine insulin, Regular insulin added to TPN bag
Keywords
total parenteral nutrition, glargine insulin, insulin
Medical subject headings
Diabetes Mellitus, Hyperphagia, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subcutaneous glargine insulinDrug

    Also called ATC code A10AE0, Lantus®, Abasaglar®

    Glargine insuline is an insulin analogue which has a prolonged duration of action. Insulin glargine is obtained by recombinant DNA technology in Escherichia coli.

  • Regular insulin added to TPN bagDrug

    Also called ATC code A10AB01, Actrapid®

    Regular insulin is human insulin produced in Saccharomyces cerevisiae by recombinant DNA technology.

Study groups in NCT02706119
Study groupRoleWhat they receive
Glargine insulinExperimentalSingle dose glargine insulin (basal component) + regular insulin within total parenteral nutrition (TPN) reservoir (prandial component). 50% of the total calculated dose of insulin is administered subcutaneously as single dose subcutaneous glargine insulin; remaining 50% of the total calculated dose of insulin is administered as regular insulin in the TPN reservoir. Interventions used: Intravenous glargine insulin, and regular insulin added to TPN bag
Receives: Drug: Subcutaneous glargine insulin; Drug: Regular insulin added to TPN bag
Regular insulinActive comparatorRegular insulin added to TPN bag (basal + prandial component). The calculated total dose of insulin is administered as regular insulin in the TPN reservoir. Interventions used: Regular insulin added to TPN bag
Receives: Drug: Regular insulin added to TPN bag

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Basal blood glucose value before starting TPN

    Basal glucose value before starting TPN (in mg/dL).

    Measured: Before starting total parenteral nutrition

  2. Periodical blood glucose

    All blood glucose values (in mg/dL) every 6 hours during 15 days of TPN infusion.

    Measured: Every 6h during 15 days of treatment

  3. Variation of average blood glucose compared with total dose of insulin

    Variation of average glucose (in mg/dL) compared with total dose of insulin (in mL), in days 1, 5 and 15 of treatment.

    Measured: In days 1, 5 and 15 of treatment

  4. Number of hypoglycaemia

    Number of symptomatic and asymptomatic hypoglycaemia with blood glucose below 70 mg/dL during TPN treatment up to 15 days.

    Measured: During TPN treatment up to 15 days

  5. Number of severe hypoglycaemia

    Number of symptomatic and asymptomatic hypoglycaemia with blood glucose below 40 mg/dL during TPN treatment up to 15 days.

    Measured: During TPN treatment up to 15 days

  6. Hypoglycemia blood glucose values

    If the patient refers typical symptoms of hypoglycemia, a measure of blood glucose (in mg/mL) is immediately taken to check the level

    Measured: Through study completion, an average of 15 days.

  7. Hypoglycemia symptoms

    If blood glucose <70 mg / dL, it is recorded whether or not the patient has symptoms consistent with hypoglycemia and how the episode terminates

    Measured: Through study completion, an average of 15 days.

Secondary outcomes (2)

  1. Standard deviation of blood glucose

    Standard deviation of blood glucose (SD): Expressed in milligrams per deciliter (in mg/dL).

    Measured: At day 15 of treatment

  2. Blood glucose coefficient of variation (CV)

    Coefficient of variation (CV): Expressed as a percentage (%). The ratio of the standard deviation of the blood glucoses values (in mg/dL) and the average blood glucose (in mg/dL), multiplied by 100.

    Measured: At day 15 of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2016 (estimated)
  2. Study start1 Jul 2016
  3. Primary completion31 Mar 2018
  4. Study completion4 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02706119
Sponsor's protocol ID
FPS-INSUPAR-2015-01
Acronym
INSUPAR
Status last verified
Apr 2018
First submitted
16 Feb 2016
Last updated
24 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • Soria-Utrilla V, Sasso CV, Romero-Zerbo SY, Adarve-Castro A, Lopez-Urdiales R, Herranz-Antolin S, Garcia-Almeida JM, Garcia-Malpartida K, Ferrer-Gomez M, Moreno-Borreguero A, Luengo-Perez LM, Alvarez-Hernandez J, Aragon-Valera C, Ocon-Breton MJ, Garcia-Manzanares A, Breton-Lesmes I, Serrano-Aguayo P, Perez-Ferre N, Lopez-Gomez JJ, Olivares-Alcolea J, Moreno-Martinez M, Tejera-Perez C, Garcia-Arias S, Abad-Gonzalez AL, Alhambra-Exposito MR, Zugasti-Murillo A, Parra-Barona J, Torrejon-Jaramillo S, Abuin J, Fernandez-Garcia JC, Olveira G; Nutrition Area of the Spanish Society of Endocrinology and Nutrition (SEEN). Biomarkers of oxidation, inflammation and intestinal permeability in persons with diabetes mellitus with parenteral nutrition: A multicenter randomized trial. Clin Nutr. 2025 Jan;44:155-164. doi: 10.1016/j.clnu.2024.11.044. Epub 2024 Dec 3.

    PubMed 39672082

  • Olveira G, Abuin J, Lopez R, Herranz S, Garcia-Almeida JM, Garcia-Malpartida K, Ferrer M, Cancer E, Luengo-Perez LM, Alvarez J, Aragon C, Ocon MJ, Garcia-Manzanares A, Breton I, Serrano-Aguayo P, Perez-Ferre N, Lopez-Gomez JJ, Olivares J, Arraiza C, Tejera C, Martin JD, Garcia S, Abad AL, Alhambra MR, Zugasti A, Parra J, Torrejon S, Tapia MJ. Regular insulin added to total parenteral nutrition vs subcutaneous glargine in non-critically ill diabetic inpatients, a multicenter randomized clinical trial: INSUPAR trial. Clin Nutr. 2020 Feb;39(2):388-394. doi: 10.1016/j.clnu.2019.02.036. Epub 2019 Mar 20.

    PubMed 30930133

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Subcutaneous glargine insulin and Regular insulin added to TPN bag in people with Diabetes Mellitus, run by Fundación Pública Andaluza Progreso y Salud at 32 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Basal blood glucose value before starting TPN (time frame: Before starting total parenteral nutrition). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02706119, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.

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