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Une étude de LY900014 chez des participants adultes atteints de diabète sucré de type 2 en Inde

1 septembre 2026 mis à jour par: Eli Lilly and Company

Une étude de phase 4, multicentrique, ouverte, à un seul bras, de 26 semaines, pour évaluer l'innocuité de Lyumjev chez les patients adultes atteints de diabète sucré de type 2 en Inde

The purpose of this study is to assess the safety of insulin lispro-aabc in adult participants with Type 2 diabetes mellitus in India.

The study will last about 33 weeks for each participant, including screening (1 week), Lead-in period (4 weeks), treatment period (26 weeks) and follow up period (2 weeks).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

153

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Inde
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, Inde, 500012
        • Osmania Medical College & Hospital
      • Visakhapatnam, Andhra Pradesh, Inde, 530002
        • King George Hospital, Visakhapatnam
    • Chennai India
      • Royapuram, Chennai India, Inde, 600013
        • Diabetes Research Centre
    • Gujarat
      • Ahmedabad, Gujarat, Inde, 380007
        • Vijyaratna Dibetes Diagnosis Treatment Centre
    • Karnataka
      • Bengaluru, Karnataka, Inde, 560043
        • Center for Diabetes and Endocrine Care
    • Maharashtra
      • Pune, Maharashtra, Inde, 411004
        • Sahyadri Super Speciality Hospital
      • Pune, Maharashtra, Inde, 411021
        • Chellaram Diabetes Institute
    • Rajasthan
      • Bikaner, Rajasthan, Inde, 334003
        • S. P. Medical College & A G Hospital
      • Jaipur, Rajasthan, Inde, 302033
        • Rajasthan University of Health Sciences
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, Inde, 641009
        • Kovai Diabetes Speciality Center and Hospital
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, Inde, 208020
        • Brij Medical Center Pvt. Ltd.
    • West Bengal
      • Kolkata, West Bengal, Inde, 700073
        • Medical College & Hospital, Kolkata

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Have Type 2 Diabetes Mellitus (T2DM) for ≥1 year prior to screening

  • Treated for ≥90 days prior to screening with multiple daily injection (MDI) therapy

    • on basal insulin or insulin glargine 100 U/mL [Basaglar or Lantus] or insulin glargin 300 U/mL, insulin determir, insulin degludec U-100, or neutral protamine Hagedorn (NPH) insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro 100 U/mL or 200 U/mL, insulin aspart, insulin glulisine, regular insulin, fast-acting insulin aspart), or
    • premixed analog or human insulin regimens with any basal and bolus insulin

  • May have been treated with up to 3 oral antihyperglycemic medications (OAMs) including metformin, sodium-glucose cotransporter (SGLT)-2 inhibitor in accordance with local regulations. The dose of all OAMs must have been stable for ≥90 days prior to screening

  • Have an HbA1c value ≥7.5% and ≤10% according to the central laboratory at screening

  • Body mass index ≤45.0 kg/m²

  • Have access to a telephone, or alternative means for close monitoring/communications

  • Have refrigeration at home or have ready access to refrigeration for storage of insulin therapy

  • Have a regular wake-sleep schedule (awake-work during the day and sleep during the night)

Exclusion Criteria:

  • Having any other condition (including known drug or alcohol abuse, psychiatric disorder including eating disorder) that precludes the subject from following and completing the protocol
  • Have been diagnosed, at any time, with type 1 diabetes mellitus (T1DM) or latent autoimmune diabetes in adults
  • Have hypoglycemia unawareness as judged by the investigator
  • Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within the 6 months prior to screening
  • Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening
  • Have a known diagnosis of secondary diabetes (for example, diabetes caused by hemochromatosis, acromegaly, chronic pancreatitis, or pancreatectomy)
  • Excessive insulin resistance defined as having received a total daily dose of insulin >2.0 U/kg at the time of screening
  • Have a history of or are being evaluated for bariatric surgery including Roux-en-Y gastric bypass surgery, gastric banding, and/or gastric sleeve
  • Have cardiovascular disease, within the past 6 months prior to screening, defined as stroke, decompensated heart failure (New York Heart Association Class III or IV), myocardial infarction, unstable angina pectoris, or coronary arterial bypass graft
  • History of renal transplantation
  • Currently receiving renal dialysis
  • Serum creatinine >2.0 mg/dL (177 µmol/L) at screening
  • Have obvious clinical signs or symptoms of liver disease (for example, acute or chronic hepatitis or cirrhosis), or elevated liver enzyme measurements
  • Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at an increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
  • Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hemoglobinopathy, anemia, or any other traits known to interfere with measurement of HbA1
  • Have presence of clinically significant gastrointestinal disease (for example, clinically active gastroparesis associated with wide glucose fluctuations) in the investigator's opinion
  • Have used thiazolidinediones, glucagon-like peptide 1 receptor agonist, or pramlintide within 90 days prior to screening

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Insulin Lispro-aabc

Participants received subcutaneous injections of insulin lispro-aabc 100 units/millilitre (U/mL) immediately (0 to 2 minutes) before each meal, in combination with once-daily insulin glargine 100 U/mL as basal insulin, during the 26-week treatment period.
Médicament: Insulin Lispro-aabc

Administered subcutaneously

Autres noms:
  • LY900014
  • Lyumjev
Médicament: Insulin Glargine

Administered subcutaneously

Autres noms:
  • Basaglar

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With at Least 1 Documented Hypoglycemic Event With Blood Glucose <54 Milligrams Per Deciliter (mg/dL)
Délai: Baseline through Week 26

The percentage of participants with at least 1 documented hypoglycemic event was calculated as the number of participants with >=1 documented hypoglycemic event divided by the total number of participants, multiplied by 100.
Baseline through Week 26
Rate of Documented Hypoglycemia With Blood Glucose <54 mg/dL
Délai: Baseline through Week 26

Rate of documented hypoglycemia (events/participant/year) was calculated as the sum of documented hypoglycemic episodes divided by the cumulative days on treatment from all participants, multiplied by 365.
Baseline through Week 26

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With Severe Hypoglycemia
Délai: Baseline through Week 26
  • Severe hypoglycemia is considered any hypoglycemic event where the participant requires assistance for recovery with or without hospitalisation and is reported as a serious adverse event.
  • The percentage of participants with at least 1 severe hypoglycemic event was calculated as the number of participants with >=1 severe hypoglycemic event divided by the total number of participants, multiplied by 100.
Baseline through Week 26
Percentage of Participants With at Least 1 Nocturnal Hypoglycemic Event With Blood Glucose <54 mg/dL
Délai: Baseline through Week 26
  • Nocturnal hypoglycemia is considered any hypoglycemic event (documented hypoglycemia or probable symptomatic hypoglycemia, including severe hypoglycemia) that occurs between bedtime and waking (11:59 PM to 5:59 AM).
  • The percentage of participants with at least 1 nocturnal hypoglycemic event was calculated as the number of participants with >=1 nocturnal hypoglycemic event divided by the total number of participants, multiplied by 100.
Baseline through Week 26
Rate of Nocturnal Hypoglycemia With Blood Glucose <54 mg/dL
Délai: Baseline through Week 26
  • Nocturnal hypoglycemia is considered any hypoglycemic event (documented hypoglycemia or probable symptomatic hypoglycemia, including severe hypoglycemia) that occurs between bedtime and waking (11:59 PM to 5:59 AM).
  • Rate of nocturnal hypoglycemia (events/participant/year) was calculated as the sum of nocturnal hypoglycemic episodes divided by the cumulative days on treatment from all participants, multiplied by 365.
Baseline through Week 26
Percentage of Participants With at Least 1 Nocturnal Hypoglycemic Event With Blood Glucose <70 mg/dL
Délai: Baseline through Week 26
  • Nocturnal hypoglycemia is considered any hypoglycemic event (documented hypoglycemia or probable symptomatic hypoglycemia, including severe hypoglycemia) that occurs between bedtime and waking (11:59 PM to 5:59 AM).
  • The percentage of participants with at least 1 nocturnal hypoglycemic event was calculated as the number of participants with >=1 nocturnal hypoglycemic event divided by the total number of participants, multiplied by 100.
Baseline through Week 26
Rate of Nocturnal Hypoglycemia With Blood Glucose <70 mg/dL
Délai: Baseline through Week 26
  • Nocturnal hypoglycemia is considered any hypoglycemic event (documented hypoglycemia or probable symptomatic hypoglycemia, including severe hypoglycemia) that occurs between bedtime and waking (11:59 PM to 5:59 AM).
  • Rate of nocturnal hypoglycemia (events/participant/year) was calculated as the sum of nocturnal hypoglycemic episodes divided by the cumulative days on treatment from all participants, multiplied by 365.
Baseline through Week 26
Percentage of Participants With at Least 1 Documented Hypoglycemic Event With Blood Glucose <70 mg/dL
Délai: Baseline through Week 26

The percentage of participants with at least 1 documented hypoglycemic event was calculated as the number of participants with >=1 documented hypoglycemic event divided by the total number of participants, multiplied by 100.
Baseline through Week 26
Rate of Documented Hypoglycemia With Blood Glucose <70 mg/dL
Délai: Baseline through Week 26

Rate of documented hypoglycemia (events/participant/year) was calculated as the sum of documented hypoglycemic episodes divided by the cumulative days on treatment from all participants, multiplied by 365.
Baseline through Week 26
Change From Baseline in Body Weight
Délai: Baseline, Week 26
Baseline, Week 26
Change From Baseline in Hemoglobin A1c (HbA1c)
Délai: Baseline, Week 26

HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.
Baseline, Week 26
Percentage of Participants Achieving HbA1c < 7%
Délai: Week 26

HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.
Week 26
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
Délai: Baseline, Week 26

The ITSQ is a 22-item questionnaire that assesses treatment satisfaction for participants taking insulin under 5 domains: Inconvenience of Regimen [5 items], Lifestyle Flexibility [3 items], Glycemic Control [3 items], Hypoglycemic Control [5 items], Insulin Delivery Device [6 items]. Each Item is measured on a 7-point scale. The overall score is calculated as the mean of all 22 items and transformed to a scale of 0 to 100 using the formula: 100*[(7 - raw overall score)/6], with higher scores indicating better treatment satisfaction.
Baseline, Week 26
Change From Baseline in 1- and 2-hour Postprandial Glucose (PPG) Values Estimated From Self-monitored Blood Glucose (SMBG) Values
Délai: Baseline, Day 3 of Week 20
Baseline, Day 3 of Week 20
Change From Baseline in Bolus Insulin Dose, Basal Insulin Dose
Délai: Baseline, Week 20
  • Bolus insulin dose, calculated as the summed daily bolus insulin dose across days 1, 2 and 3 divided by the number of non-missing data days.
  • Basal insulin dose, calculated as the summed daily basal insulin dose across days 1, 2 and 3 divided by the number of non-missing data days.
Baseline, Week 20
Change From Baseline in Basal to Bolus Insulin Dose Ratio
Délai: Baseline, Week 20

Basal to Bolus insulin dose ratio, calculated as the basal insulin dose divided by the basal insulin dose.

  • Bolus insulin dose, calculated as the summed daily bolus insulin dose across days 1, 2 and 3 divided by the number of non-missing data days.
  • Basal insulin dose, calculated as the summed daily basal insulin dose across days 1, 2 and 3 divided by the number of non-missing data days
Baseline, Week 20
Change From Baseline in 9-Point Self-Monitored Blood Glucose (SMBG) Values
Délai: Baseline, Week 20

SMBG measurements were taken at 9 time points: fasting, 1 hour post-breakfast, 2 hours post-breakfast, pre-lunch, 1 hour post-lunch, 2 hours post-lunch, pre-dinner, 1 hour post-dinner, and 2 hours post-dinner. The SMBG value was calculated as the average of the corresponding SMBG measurements collected on Days 1, 2, and 3 across cumulative non-missing data days.
Baseline, Week 20

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Eli Lilly and Company

Collaborateurs

Cipla Ltd.

Les enquêteurs

  • Directeur d'études: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

18 avril 2024

Achèvement primaire (Réel)

2 septembre 2025

Achèvement de l'étude (Réel)

2 septembre 2025

Dates d'inscription aux études

Première soumission

15 avril 2024

Première soumission répondant aux critères de contrôle qualité

15 avril 2024

Première publication (Réel)

17 avril 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 18269
  • I8B-MC-ITTA (Autre identifiant: Eli Lilly and Company)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Délai de partage IPD

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

Critères d'accès au partage IPD

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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