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Studie LY900014 u dospělých účastníků s diabetes mellitus 2. typu v Indii

1. září 2026 aktualizováno: Eli Lilly and Company

26týdenní, multicentrická, otevřená, jednoramenná studie fáze 4 k posouzení bezpečnosti přípravku Lyumjev u dospělých pacientů s diabetes mellitus 2. typu v Indii

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).

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

153

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: Insulin Lispro-aabc

Administered subcutaneously

Ostatní jména:
  • LY900014
  • Ljumjev
Lék: Insulin Glargine

Administered subcutaneously

Ostatní jména:
  • Basaglar

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants With at Least 1 Documented Hypoglycemic Event With Blood Glucose <54 Milligrams Per Deciliter (mg/dL)
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants With Severe Hypoglycemia
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline, Week 26
Baseline, Week 26
Change From Baseline in Hemoglobin A1c (HbA1c)
Časové okno: 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%
Časové okno: 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
Časové okno: 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
Časové okno: Baseline, Day 3 of Week 20
Baseline, Day 3 of Week 20
Change From Baseline in Bolus Insulin Dose, Basal Insulin Dose
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Eli Lilly and Company

Spolupracovníci

Cipla Ltd.

Vyšetřovatelé

  • Ředitel studie: 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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

18. dubna 2024

Primární dokončení (Aktuální)

2. září 2025

Dokončení studie (Aktuální)

2. září 2025

Termíny zápisu do studia

První předloženo

15. dubna 2024

První předloženo, které splnilo kritéria kontroly kvality

15. dubna 2024

První zveřejněno (Aktuální)

17. dubna 2024

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 18269
  • I8B-MC-ITTA (Jiný identifikátor: Eli Lilly and Company)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Časový rámec sdílení 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.

Kritéria přístupu pro sdílení IPD

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

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ano

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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