Diabetes Mellitus, Type 1Phase 3ELEMENT 1NCT01421147
A Study in Adults With Type 1 Diabetes
A Phase 3 study testing LY2963016, Lantus and Insulin Lispro in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 52 sites in 9 countries.
Trial summary
The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- LY2963016, Lantus and Insulin Lispro
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 52 sitesin 9 countries
- Study dates
- Aug 2011to Apr 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 diabetes mellitus based on the disease diagnostic criteria [World Health Organization (WHO) Classification]
- Have duration of diabetes greater than or equal to one year
- Have Hemoglobin A1c (HbA1c) less than or equal to 11.0%
- On basal-bolus insulin therapy for at least 1 year [basal insulin must be once daily (QD) injection of human insulin isophane suspension (NPH), Lantus, or detemir and combined with mealtime injections of human regular insulin, or insulin analog lispro, aspart or glulisine]
- Have a body mass index (BMI) of less than or equal to 35 kilograms/square meter (kg/m²)
Who cannot join
- Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study
- Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months before entering the study
- Have known hypersensitivity or allergy to any of the study insulins (insulin glargine or insulin lispro) or to excipients of the study insulins
- Have significant renal, cardiac, gastrointestinal or liver disease
- Have active cancer or cancer within the past 5 years
Trial locations and contacts
52 sites in 9 countries.
52 sites in 9 countries
United States21 sites
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Asheville, North Carolina, 28803
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Atlanta, Georgia, 30303
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Austin, Texas, 78731
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Birmingham, Alabama, 35294
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Dallas, Texas, 75390
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Des Moines, Iowa, 50314
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Hollywood, Florida, 33021
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Kalamazoo, Michigan, 49048
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Lexington, Kentucky, 40503
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Metairie, Louisiana, 70006
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Mineola, New York, 11501
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Nashua, New Hampshire, 03063
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New Hyde Park, New York, 11040
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New Port Richey, Florida, 34652
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Omaha, Nebraska, 68131
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Roswell, Georgia, 30076
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San Antonio, Texas, 78229
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Springfield, Illinois, 62704
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Syracuse, New York, 13210
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Topeka, Kansas, 66606
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West Palm Beach, Florida, 33401
Japan6 sites
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Fukuoka, 815-8555
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Kanagawa, 235-0045
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Kumamoto, 862-0976
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Miyazaki, 880-0034
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Nagasaki, 857-1195
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Tokyo, 105-8471
Romania5 sites
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Bucharest, 020359
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Galati, 800587
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Iași, 700547
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Oradea, 410025
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Timișoara, 300182
Germany4 sites
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Fulda, 36037
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Hamburg, 22607
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Heidelberg, 69115
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Saint Ingbert-Oberwürzbach, 66386
Mexico4 sites
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Guadalajara, 44600
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Monterrey, 64461
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Puebla City, 72190
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Tampico, 89249
Belgium3 sites
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Brussels, 1090
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Leuven, 3000
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Liège, 4000
Greece3 sites
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Athens, 11527
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Haidari/Athens, 12462
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Thessaloniki, 56429
Hungary3 sites
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Budapest, 1134
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Debrecen, 4032
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Salgótarján, 3100
Poland3 sites
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Krakow, 31-530
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Lodz, 90-153
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Szczecin, 70-376
About this study
Official title: A Prospective, Randomized, Open-label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Combination With Mealtime Insulin Lispro in Adult Patients With Type 1 Diabetes Mellitus
The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- LY2963016, Lantus, Insulin Lispro
- Keywords
- Diabetes, Type 1 Diabetes, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2963016Drug
Administered subcutaneously
LantusDrug
Administered subcutaneously
Insulin LisproDrug
Administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| LY2963016 + Insulin Lispro | Experimental | LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks. Receives: Drug: LY2963016; Drug: Insulin Lispro |
| Lantus + Insulin Lispro | Active comparator | Lantus titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks. Receives: Drug: Lantus; Drug: Insulin Lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Measured: Baseline, Endpoint (up to 24 weeks)
Secondary outcomes (12)
Change From Baseline in Insulin Antibody Levels
Blood samples are collected from participants and percentage of insulin antibody binding was measured to determine the insulin antibody levels. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Measured: Baseline, 6 weeks and 12 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Measured: Baseline, 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoint (up to 52 weeks)
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
7-point SMBG measurements are completed at the following timepoints: Morning (AM) Pre-Meal, AM Post-Prandial (PP), Midday (MD) Pre-Meal, MD PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Values for the 7-point SMBG profiles were averaged over the three 7-point SMBG profiles during 2-week period prior to each visit. If only 1 of the 3 days of data was collected, then the value of the 1 day was used. If only 2 of the 3 days of data were collected, then the average of the 2 days was used. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Measured: Baseline and Endpoints [up to 24 weeks (wk) and up to 52 weeks]
Glycemic Variability of Fasting Blood Glucose
Glycemic variability is the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning premeal blood glucose value from the 7-point self-monitoring blood glucose (SMBG) profiles. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Measured: Baseline and Endpoints (up to 24 weeks and up 52 weeks)
Change From Baseline in Body Weight
Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Measured: Baseline, 6 weeks and 12 weeks and 18 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
Adult Low Blood Sugar Survey (ALBSS)
ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score (TS) range is 0 to 60 and Worry TS range is 0 to 72. Higher scores on "Behavior" items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on "Worry" items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Measured: Baseline and 24 weeks and Endpoint (up to 52 weeks)
Insulin Treatment Satisfaction Questionnaire (ITSQ)
ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. Items divided into 5 domains: Inconvenience of Regimen [(IR) 5 items: scores range 5-35], Lifestyle Flexibility [(LF) 3 items: scores range 3-21], Glycemic Control [(GC) 3 items: scores range 3-21], Hypoglycemic Control [(HC) 5 items: scores range 5-35], Insulin Delivery Device [(IDD) 6 items: scores range 6-42]. ITSQ Total Overall Scores range from 22-154. Data presented are the transformed score on a scale of 0-100, where transformed score=100×[(7-raw score)/6]. Higher scores indicate better treatment satisfaction. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Measured: Baseline and 24 weeks and Endpoint (up to 52 weeks)
Insulin Dose Per Body Weight (U/kg) (Total and by Component [Basal and Bolus (Lispro)])
Total daily insulin dose was adjusted for body weight [units of insulin/kilogram/day (U/kg/day)]. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Measured: Endpoints [up to 24 weeks (wk) and up to 52 weeks]
Insulin Dose - Units [Total and by Component [Basal and Bolus (Lispro)])
Units of insulin taken daily were presented. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Measured: Endpoints [up to 24 weeks (wk) and up to 52 weeks]
Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% and HbA1c ≤6.5%
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. The percentage of participants with Hemoglobin A1c (HbA1c) <7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100.
Measured: Baseline and 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
Incidence of Hypoglycemic Events
Incidence of hypoglycemic events is defined as the number of hypoglycemic events. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose (BG) concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines [American Diabetes Association (ADA) 2005]. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.
Measured: Baseline through 24 weeks (wk) and 52 weeks
Rate Per 30 Days of Hypoglycemic Events
The rate of hypoglycemic events per 30 days is defined as the total number of events between visits divided by the actual number of days between visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005). Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.
Measured: Baseline through 24 weeks (wk) and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionApr 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- 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
- NCT01421147
- Sponsor's protocol ID
- 13712
- Other IDs
- I4L-MC-ABEB, 2011-000829-73
- Acronym
- ELEMENT 1
- Status last verified
- Oct 2014
- First submitted
- 19 Aug 2011
- Last updated
- 9 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Nishiyama H, Shingaki T, Suzuki Y, Ilag LL. Similar Intrapatient Blood Glucose Variability with LY2963016 and Lantus(R) Insulin Glargine in Patients with Type 1 (T1D) or Type 2 Diabetes, Including a Japanese T1D Subpopulation. Diabetes Ther. 2018 Aug;9(4):1469-1476. doi: 10.1007/s13300-018-0450-0. Epub 2018 May 31.
PubMed 29855972
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Combination With Mealtime Insulin Lispro in Adult Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01421147
- Acronym / sponsor ID
- ELEMENT 1 / 13712
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes, Type 1 Diabetes, Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Posted 9 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY2963016 + Insulin Lispro | Experimental | Drug: LY2963016, Drug: Insulin LisproLY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks. |
| Lantus + Insulin Lispro | Active comparator | Drug: Lantus, Drug: Insulin LisproLantus titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have type 1 diabetes mellitus based on the disease diagnostic criteria [World Health Organization (WHO) Classification]
- Have duration of diabetes greater than or equal to one year
- Have Hemoglobin A1c (HbA1c) less than or equal to 11.0%
- On basal-bolus insulin therapy for at least 1 year [basal insulin must be once daily (QD) injection of human insulin isophane suspension (NPH), Lantus, or detemir and combined with mealtime injections of human regular insulin, or insulin analog lispro, aspart or glulisine]
- Have a body mass index (BMI) of less than or equal to 35 kilograms/square meter (kg/m²)
Key exclusion criteria (5 listed)
- Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study
- Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months before entering the study
- Have known hypersensitivity or allergy to any of the study insulins (insulin glargine or insulin lispro) or to excipients of the study insulins
- Have significant renal, cardiac, gastrointestinal or liver disease
- Have active cancer or cancer within the past 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2963016Administered subcutaneously | Drug | LY2963016 + Insulin Lispro |
| LantusAdministered subcutaneously | Drug | Lantus + Insulin Lispro |
| Insulin LisproAdministered subcutaneously | Drug | LY2963016 + Insulin Lispro, Lantus + Insulin Lispro |
Primary outcome
Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Endpoint (up to 24 weeks)
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
12 secondary outcomes
Change From Baseline in Insulin Antibody Levels
Time frame: Baseline, 6 weeks and 12 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoint (up to 52 weeks)
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Time frame: Baseline and Endpoints [up to 24 weeks (wk) and up to 52 weeks]
Glycemic Variability of Fasting Blood Glucose
Time frame: Baseline and Endpoints (up to 24 weeks and up 52 weeks)
Change From Baseline in Body Weight
Time frame: Baseline, 6 weeks and 12 weeks and 18 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
Adult Low Blood Sugar Survey (ALBSS)
Time frame: Baseline and 24 weeks and Endpoint (up to 52 weeks)
Insulin Treatment Satisfaction Questionnaire (ITSQ)
Time frame: Baseline and 24 weeks and Endpoint (up to 52 weeks)
Insulin Dose Per Body Weight (U/kg) (Total and by Component [Basal and Bolus (Lispro)])
Time frame: Endpoints [up to 24 weeks (wk) and up to 52 weeks]
Insulin Dose - Units [Total and by Component [Basal and Bolus (Lispro)])
Time frame: Endpoints [up to 24 weeks (wk) and up to 52 weeks]
Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% and HbA1c ≤6.5%
Time frame: Baseline and 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
Incidence of Hypoglycemic Events
Time frame: Baseline through 24 weeks (wk) and 52 weeks
Rate Per 30 Days of Hypoglycemic Events
Time frame: Baseline through 24 weeks (wk) and 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29855972Nishiyama H, Shingaki T, Suzuki Y, Ilag LL. Similar Intrapatient Blood Glucose Variability with LY2963016 and Lantus(R) Insulin Glargine in Patients with Type 1 (T1D) or Type 2 Diabetes, Including a Japanese T1D Subpopulation. Diabetes Ther. 2018 Aug;9(4):1469-1476. doi: 10.1007/s13300-018-0450-0. Epub 2018 May 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
52 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LY2963016, Lantus and Insulin Lispro in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 52 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Japan, Romania, Germany, Mexico and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c) (time frame: Baseline, Endpoint (up to 24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01421147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2014.