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Een onderzoek naar LY900014 bij volwassen deelnemers met diabetes mellitus type 2 in India

1 september 2026 bijgewerkt door: Eli Lilly and Company

Een 26 weken durende, multicenter, open-label, eenarmige, fase 4-studie om de veiligheid van Lyumjev bij volwassen patiënten met diabetes mellitus type 2 in India te beoordelen

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).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

153

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Insulin Lispro-aabc

Administered subcutaneously

Andere namen:
  • LY900014
  • Lyumjev
Geneesmiddel: Insulin Glargine

Administered subcutaneously

Andere namen:
  • Basaglar

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With at Least 1 Documented Hypoglycemic Event With Blood Glucose <54 Milligrams Per Deciliter (mg/dL)
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Severe Hypoglycemia
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, Week 26
Baseline, Week 26
Change From Baseline in Hemoglobin A1c (HbA1c)
Tijdsspanne: 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%
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, Day 3 of Week 20
Baseline, Day 3 of Week 20
Change From Baseline in Bolus Insulin Dose, Basal Insulin Dose
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Eli Lilly and Company

Medewerkers

Cipla Ltd.

Onderzoekers

  • Studie directeur: 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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 april 2024

Primaire voltooiing (Werkelijk)

2 september 2025

Studie voltooiing (Werkelijk)

2 september 2025

Studieregistratiedata

Eerst ingediend

15 april 2024

Eerst ingediend dat voldeed aan de QC-criteria

15 april 2024

Eerst geplaatst (Werkelijk)

17 april 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 september 2026

Laatste update ingediend die voldeed aan QC-criteria

1 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 18269
  • I8B-MC-ITTA (Andere identificatie: Eli Lilly and Company)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

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.

IPD-toegangscriteria voor delen

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

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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