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En studie av LY900014 hos vuxna deltagare med typ 2-diabetes mellitus i Indien

1 september 2026 uppdaterad av: Eli Lilly and Company

En 26-veckors, multicenter, öppen etikett, singelarm, fas 4-studie för att bedöma säkerheten för Lyumjev hos vuxna patienter med typ 2-diabetes mellitus i Indien

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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

153

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Insulin Lispro-aabc

Administered subcutaneously

Andra namn:
  • LY900014
  • Lyumjev
Läkemedel: Insulin Glargine

Administered subcutaneously

Andra namn:
  • Basaglar

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With at Least 1 Documented Hypoglycemic Event With Blood Glucose <54 Milligrams Per Deciliter (mg/dL)
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With Severe Hypoglycemia
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline, Week 26
Baseline, Week 26
Change From Baseline in Hemoglobin A1c (HbA1c)
Tidsram: 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%
Tidsram: 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
Tidsram: 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
Tidsram: Baseline, Day 3 of Week 20
Baseline, Day 3 of Week 20
Change From Baseline in Bolus Insulin Dose, Basal Insulin Dose
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Eli Lilly and Company

Samarbetspartners

Cipla Ltd.

Utredare

  • Studierektor: 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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

18 april 2024

Primärt slutförande (Faktisk)

2 september 2025

Avslutad studie (Faktisk)

2 september 2025

Studieregistreringsdatum

Först inskickad

15 april 2024

Först inskickad som uppfyllde QC-kriterierna

15 april 2024

Första postat (Faktisk)

17 april 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 18269
  • I8B-MC-ITTA (Annan identifierare: Eli Lilly and Company)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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