Diabetes Mellitus, Type 2Phase 4NCT06370715
A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India
A Phase 4 study testing Insulin Lispro-aabc and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 12 sites in India.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Lispro-aabc and Insulin Glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 12 sitesIndia
- Study dates
- 18 Apr 2024to 2 Sep 2025
- Phase
- Phase 4
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
- 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
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- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
India12 sites
Vijyaratna Dibetes Diagnosis Treatment Centre
Ahmedabad, Gujarat, 380007
Center for Diabetes and Endocrine Care
Bengaluru, Karnataka, 560043
S. P. Medical College & A G Hospital
Bikaner, Rajasthan, 334003
Kovai Diabetes Speciality Center and Hospital
Coimbatore, Tamil Nadu, 641009
Osmania Medical College & Hospital
Hyderabad, Andhra Pradesh, 500012
Rajasthan University of Health Sciences
Jaipur, Rajasthan, 302033
Brij Medical Center Pvt. Ltd.
Kanpur, Uttar Pradesh, 208020
Medical College & Hospital, Kolkata
Kolkata, West Bengal, 700073
Sahyadri Super Speciality Hospital
Pune, Maharashtra, 411004
Chellaram Diabetes Institute
Pune, Maharashtra, 411021
Diabetes Research Centre
Royapuram, Chennai India, 600013
King George Hospital, Visakhapatnam
Visakhapatnam, Andhra Pradesh, 530002
About this study
Official title: A 26- Week, Multicenter, Open-Label, Single-Arm, Phase 4 Study to Assess The Safety of Lyumjev in Adult Patients With Type 2 Diabetes Mellitus in India
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).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Lispro-aabc, Insulin Glargine
- Keywords
- Diabetes mellitus, type 2 diabetes, Lyumjev, basaglar, Humalog
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Lispro-aabcDrug
Also called LY900014, Lyumjev
Administered subcutaneously
Insulin GlargineDrug
Also called Basaglar
Administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Insulin Lispro-aabc | Experimental | 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. Receives: Drug: Insulin Lispro-aabc; Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least 1 Documented Hypoglycemic Event With Blood Glucose <54 Milligrams Per Deciliter (mg/dL)
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.
Measured: Baseline through Week 26
Rate of Documented Hypoglycemia With Blood Glucose <54 mg/dL
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.
Measured: Baseline through Week 26
Secondary outcomes (15)
Percentage of Participants With Severe Hypoglycemia
- 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.
Measured: Baseline through Week 26
Percentage of Participants With at Least 1 Nocturnal Hypoglycemic Event With Blood Glucose <54 mg/dL
- 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.
Measured: Baseline through Week 26
Rate of Nocturnal Hypoglycemia With Blood Glucose <54 mg/dL
- 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.
Measured: Baseline through Week 26
Percentage of Participants With at Least 1 Nocturnal Hypoglycemic Event With Blood Glucose <70 mg/dL
- 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.
Measured: Baseline through Week 26
Rate of Nocturnal Hypoglycemia With Blood Glucose <70 mg/dL
- 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.
Measured: Baseline through Week 26
Percentage of Participants With at Least 1 Documented Hypoglycemic Event With Blood Glucose <70 mg/dL
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.
Measured: Baseline through Week 26
Rate of Documented Hypoglycemia With Blood Glucose <70 mg/dL
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.
Measured: Baseline through Week 26
Change From Baseline in Body Weight
Measured: Baseline, Week 26
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.
Measured: Baseline, Week 26
Percentage of Participants Achieving HbA1c < 7%
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.
Measured: Week 26
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
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.
Measured: Baseline, Week 26
Change From Baseline in 1- and 2-hour Postprandial Glucose (PPG) Values Estimated From Self-monitored Blood Glucose (SMBG) Values
Measured: Baseline, Day 3 of Week 20
Change From Baseline in Bolus Insulin Dose, 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.
Measured: Baseline, Week 20
Change From Baseline in Basal to Bolus Insulin Dose Ratio
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
Measured: Baseline, Week 20
Change From Baseline in 9-Point Self-Monitored Blood Glucose (SMBG) Values
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.
Measured: Baseline, Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start18 Apr 2024
- Primary completion2 Sep 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cipla Ltd.
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370715
- Sponsor's protocol ID
- 18269
- Other IDs
- I8B-MC-ITTA
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2024
- Last updated
- 28 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.