Diabetes Mellitus, Type 2Phase 4AUTONOMYNCT01215955

Study of Insulin Lispro in Participants With Inadequately Controlled Type 2 Diabetes

A Phase 4 study testing Insulin lispro and Glargine in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 76 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Evidence regarding optimal methods of insulin dose adjustment is lacking in the literature. The purpose of this study is to evaluate the efficacy and safety of two approaches to escalate prandial insulin therapy in participants with type 2 diabetes mellitus not achieving adequate glycemic control on basal insulin. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Insulin lispro and Glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,117 participants
Where: 76 sitesin 15 countries
Study dates: Dec 2010to Jan 2013
Phase: Phase 4
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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have type 2 diabetes
Have been treated for at least 90 days with insulin glargine, neutral protamine Hagedorn (NPH), or detemir in combination with oral antihyperglycemic agents as monotherapy, dual, or triple therapy [sulfonylurea, meglitinide, metformin, pioglitazone, or dipeptidyl peptidase-4 (DPP-4) inhibitor] and in the opinion of the investigator requires further intensification of therapy
Are treated with insulin glargine, NPH, or detemir at least 20 units per day (U/day) at enrollment
Have an glycated hemoglobin (HbA1c) value greater than 7.0% and less than or equal to 12.0% according to the central laboratory at screening
Capable of and willing to do the following: inject insulin with a prefilled pen, perform self blood glucose monitoring and record keeping as required by this protocol, as determined by the investigator
Have given written informed consent to participate in this study in accordance with local regulations

Who cannot join

Prior rapid- or short-acting insulin therapy: participants receiving scheduled long-term short-acting or rapid-acting or premixed insulin therapy within the past 6 months will not be eligible to participate in the study. Participants who have previously received short- or rapid-acting insulin as part of short-term insulin therapy (during gestational diabetes, during an acute hospitalization or illness) or occasional use will be allowed to participate in this study. Occasional use (e.g., used to treat acute hyperglycemia) shall be defined as less than daily administration of not more than 1 dose per day of short- or rapid-acting insulin
Concomitant medications: glucagon-like peptide-1 (GLP-1) receptor agonist, alpha-glucosidase inhibitor, or rosiglitazone use concurrently or within 3 months prior to entry into the study
Severe hypoglycemia: have had more than one episode of severe hypoglycemia (defined as requiring assistance of a third party due to disabling hypoglycemia) within 6 months prior to entry into the study
Excessive insulin resistance: received a total daily dose of insulin greater than 2.0 units per kilogram (U/kg) at the time of randomization
Morbid obesity: defined as a body mass index greater than or equal to 45 kilograms per square meter (kg/m²)
Malignancy: have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years

Show all 16Show fewer

Cardiovascular: have cardiac disease with functional status that is New York Heart Association Class III or IV (see New York Heart Association Cardiac Disease Classifications) or have Congestive Heart Failure (CHF) requiring pharmacologic treatment or, in the investigator's opinion, have severe dependent edema (i.e., edema of the feet or ankles) or have any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis
Renal: have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dL) if not on metformin
Hepatic: have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) greater than 3 times the upper limit of the reference range as defined by the central laboratory
Hematologic: have known hemoglobinopathy or chronic anemia or other known blood disorder
Reproductive:(for women) are pregnant or intend to become pregnant during the course of the study; are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable; or are breastfeeding
Allergy: have known allergy to insulin lispro, insulin glargine, or excipients contained in these products
Glucocorticoid therapy: receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately before screening
Adherence to protocol: have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes the participant from following and completing the protocol
Prior participation: are currently enrolled in, or have participated in, an interventional medical, surgical, or pharmaceutical drug or device or off-label use study (an investigational study in which a medical or surgical treatment was given) within 30 days prior to entry into the study, or persons who have previously completed or withdrawn from this study (after having signed the informed consent document). Participants may be ineligible if they are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Non-approved drug: have been treated with a drug within the last 30 days that has not received regulatory approval at the time of study entry

Trial locations and contacts

76 sites in 15 countries.

Country

City, postcode or hospital

76 sites in 15 countries

United States33 sites

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Beaver, Pennsylvania, 15009
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Bradenton, Florida, 34208
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Clarkson Valley, Missouri, 63011
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Concord, California, 94520
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Dallas, Texas, 75231
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Dayton, Ohio, 45439
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Des Moines, Iowa, 50314
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Evansville, Indiana, 47714
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Flemington, New Jersey, 08822
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Fresno, California, 93720
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Haverhill, Massachusetts, 01830
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Houston, Texas, 77095
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Idaho Falls, Idaho, 83404
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Jacksonville, Florida, 32209
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Lakewood, California, 90712
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Lancaster, California, 93534
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Las Vegas, Nevada, 89119
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Lewiston, Idaho, 83501
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Lexington, Kentucky, 40503
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Metairie, Louisiana, 70006
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Minneapolis, Minnesota, 55416
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Mission Hills, California, 91345
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Orlando, Florida, 32806
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Pembroke Pines, Florida, 33027
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Philadelphia, Pennsylvania, 19107
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Phoenix, Arizona, 85050
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Portland, Oregon, 97210
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San Antonio, Texas, 78229
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Shreveport, Louisiana, 71106
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Syracuse, New York, 13210
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Topeka, Kansas, 66606
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Troy, Michigan, 48085
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Tustin, California, 92780

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Mexico5 sites

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Cuauhtémoc, 06090
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Guadalajara, 44150
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Guadalajara Jalisco, 04460
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Mexico City, 03300
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Monterrey, 64710

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Puerto Rico5 sites

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Caguas, 00726
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Manati, 00674
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Ponce, 007171563
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Rio Piedras, 00921
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San Juan, 00917

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Poland4 sites

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Lodz, 90-242
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Lublin, 20-538
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Poznan, 61-655
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Szczecin, 70-506

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Argentina3 sites

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Buenos Aires, C1425AGC
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Mar del Plata, B7600FZN
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Rosario, 2000

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Brazil3 sites

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Belém, 66073-000
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Curitiba, 80060-900
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Maringá, 87015-320

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Canada3 sites

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Charlottetown, Prince Edward Island, C1A 1L2
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Sherbrooke, Quebec, J1G 2E9
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Winnipeg, Manitoba, R3E 3P4

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Croatia3 sites

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Osijek, 31000
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Slavonski Brod, 35 000
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Zagreb, 10000

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Denmark3 sites

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Copenhagen, 2400
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Frederiksberg, 2000
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Kolding, 6000

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France3 sites

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Bourges, 18000
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La Bouëxière, 35340
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Nantes, 44300

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Lithuania3 sites

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Kaunas, LT-51270
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Raseiniai, 60127
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Ukmerge, 20184

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Russia3 sites

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Saint Petersburg, 197022
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Saratov, 410053
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Stavropol, 355035

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Romania2 sites

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Bucharest, 022441
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Oradea, 410169

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South Africa2 sites

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Halfway House, 1685
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Somerset West, 7130

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Austria1 site

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Vienna, 1130

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About this study

Official title: Two Approaches to Escalate Lispro Therapy in Patients With Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on Basal Insulin Therapy and Oral Agents Alone (AUTONOMY)

Read the detailed description

Participants who enter the study and are already taking insulin glargine with a screening HbA1c >7.0% will be randomized to one of two treatment arms. Both arms will add prandial insulin to existing basal insulin therapy.

Conditions: Diabetes Mellitus, Type 2
Being tested: Insulin lispro, Glargine
Keywords: Type 2 Diabetes, Insulin, Algorithms, Blood glucose levels
Medical subject headings: Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Insulin lisproDrug
Also called Humalog, LY275585
Administered subcutaneously, up to three times daily for 24 weeks
GlargineDrug
Administered subcutaneously, dosage determined by investigator once daily for 24 weeks

Study groups in NCT01215955
Study group	Role	What they receive
3 Day Algorithm	Experimental	Basal insulin glargine plus mealtime bolus insulin lispro titrated based on blood glucose readings from the past three days. (Sites were assigned to Study A and Study B according to an allocation plan that was pre-specified before initiation of Study A and Study B) Receives: Drug: Insulin lispro; Drug: Glargine
Daily Algorithm	Experimental	Basal insulin glargine plus mealtime bolus insulin lispro titrated based on blood glucose readings from the previous day. (Sites were assigned to Study A and Study B according to an allocation plan that was pre-specified before initiation of Study A and Study B) Receives: Drug: Insulin lispro; Drug: Glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to 24 Week Endpoint in Glycated Hemoglobin (HbA1c)
The change from baseline to 24 weeks in the percentage of HbA1c in plasma. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: fixed effects for treatment, country, sulfonylurea/meglitinide use, visit, treatment by visit interaction with baseline HbA1c as a covariate.
Measured: Baseline, 24 weeks

Secondary outcomes (14)

Percentage of Participants Achieving Glycated Hemoglobin (HbA1c) Target Values
Percentage of participants who achieved HbA1c levels of ≤7.0% or ≤6.5%.
Measured: 24-week endpoint
Percentage of Participants ≥65 Years of Age Achieving Glycated Hemoglobin (HbA1c) Target Concentration
Percentage of participants ≥65 years of age achieving HbA1c target concentration of ≤7.0% or ≤6.5%.
Measured: 24-week endpoint
Change From Baseline to 24 Week Endpoint in Body Weight
Body weight was measured twice at each indicated visit and the average of the 2 measurements was used for analyses. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction .
Measured: Baseline, 24-weeks
Time to Reach Glycated Hemoglobin (HbA1c) Target Values
Percentage of participants is the number of participants who achieved HbA1c target values of ≤6.5% or ≤7.0% during the specified time period divided by the total number of participants who did not discontinue from the study but had not reached HbA1c target at the beginning of the specified post baseline time period (≤100 days and ≥101 days). Participants who did not experience an outcome before discontinuation or completion of the study were censored using the date of discontinuation. Participants who were lost to follow up the date of discontinuation were considered to be the date of last contact.
Measured: Baseline through 24 weeks
Change From Baseline to 24 Week Endpoint in Fasting Glucose
Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.
Measured: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in Fasting Glucose in Participants ≥65 Years of Age
Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.
Measured: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in 1,5-anhydroglucitol (1,5-AG)
Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.
Measured: Baseline, 24 weeks
Change From Baseline to 24 Weeks in 7-Point Self-Monitored Blood Glucose (SMBG) Profile
7-Point Self-Monitored Blood Glucose profiles are measures of blood glucose concentration taken 7 time a day at the morning pre-meal, morning 2-hours (HR) postprandial (PP), midday pre-meal, midday 2-hours post-meal, evening pre-meal, bedtime and 0300 hour (3 am). Each participant took measures over any 3 days and the average was calculated for each of the 7 time points. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.
Measured: Baseline, 24 weeks
Daily Dose of Insulin: Total, Basal and Prandial (Bolus)
Total insulin was the sum of basal insulin (glargine) that was required to manage normal daily blood fluctuations and prandial insulin that was taken at meal time. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.
Measured: 24 weeks
Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial (Bolus)
Total insulin was the sum of basal insulin (glargine) that was required to manage normal daily blood fluctuations and prandial insulin that was taken at meal time. Total, basal and prandial amounts were then divided by the participant's body weight in kilograms (kg). Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.
Measured: 24 weeks
The Number of Participants With a Hypoglycemic Episode (Incidence)
A hypoglycemic episode was defined as any time a participant felt they were experiencing a sign or symptom that was associated with hypoglycemia, or had a blood glucose level of ≤70 milligram per deciliter [mg/dL, ≤3.9 millimoles per liter (mmol/L)] even if it was not associated with signs, symptoms or treatment (consistent with current American Diabetes Association 2005 guidelines).
Measured: Randomization through 24 weeks overall
The Number of Participants ≥65 Years of Age With Hypoglycemic Episodes (Incidence)
A hypoglycemic episode in participants ≥ 65 years of age was defined as any time a participant felt they were experiencing a sign or symptom that was associated with hypoglycemia, or had a blood glucose level of ≤70 milligram per deciliter [mg/dL, ≤3.9 millimoles per liter (mmol/L)] even if it was not associated with signs, symptoms or treatment (consistent with current American Diabetes Association 2005 guidelines).
Measured: Randomization through 24 weeks overall
The Rate of Hypoglycemic Episodes
The hypoglycemia rate per 30 days was calculated as the number of hypoglycemic episodes reported divided by the number of days at risk times 30.
Measured: Randomization through 24 weeks overall
Percentage of Participants With Severe Hypoglycemic Episodes
Severe hypoglycemia is defined as an 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. Plasma glucose measurements may not be available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by low plasma glucose.
Measured: Randomization up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Jan 2013

First posted7 Oct 2010 (estimated)
Study startDec 2010
Primary completionJan 2013
Study completionJan 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.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01215955
Sponsor's protocol ID: 13460
Other IDs: F3Z-MC-IOQC
Acronym: AUTONOMY
Status last verified: Apr 2014
First submitted: 30 Sep 2010
Last updated: 23 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Two Approaches to Escalate Lispro Therapy in Patients With Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on Basal Insulin Therapy and Oral Agents Alone (AUTONOMY)
ClinicalTrials.gov ID: NCT01215955
Acronym / sponsor ID: AUTONOMY / 13460
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes, Insulin, Algorithms, Blood glucose levels
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,117 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 7 Oct 2010 (estimated)
Results: Posted 27 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
3 Day Algorithm	Experimental	Drug: Insulin lispro, Drug: GlargineBasal insulin glargine plus mealtime bolus insulin lispro titrated based on blood glucose readings from the past three days. (Sites were assigned to Study A and Study B according to an allocation plan that was pre-specified before initiation of Study A and Study B)
Daily Algorithm	Experimental	Drug: Insulin lispro, Drug: GlargineBasal insulin glargine plus mealtime bolus insulin lispro titrated based on blood glucose readings from the previous day. (Sites were assigned to Study A and Study B according to an allocation plan that was pre-specified before initiation of Study A and Study B)

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Have type 2 diabetes
Have been treated for at least 90 days with insulin glargine, neutral protamine Hagedorn (NPH), or detemir in combination with oral antihyperglycemic agents as monotherapy, dual, or triple therapy [sulfonylurea, meglitinide, metformin, pioglitazone, or dipeptidyl peptidase-4 (DPP-4) inhibitor] and in the opinion of the investigator requires further intensification of therapy
Are treated with insulin glargine, NPH, or detemir at least 20 units per day (U/day) at enrollment
Have an glycated hemoglobin (HbA1c) value greater than 7.0% and less than or equal to 12.0% according to the central laboratory at screening
Capable of and willing to do the following: inject insulin with a prefilled pen, perform self blood glucose monitoring and record keeping as required by this protocol, as determined by the investigator

Key exclusion criteria (16 listed)

Prior rapid- or short-acting insulin therapy: participants receiving scheduled long-term short-acting or rapid-acting or premixed insulin therapy within the past 6 months will not be eligible to participate in the study. Participants who have previously received short- or rapid-acting insulin as part of short-term insulin therapy (during gestational diabetes, during an acute hospitalization or illness) or occasional use will be allowed to participate in this study. Occasional use (e.g., used to treat acute hyperglycemia) shall be defined as less than daily administration of not more than 1 dose per day of short- or rapid-acting insulin
Concomitant medications: glucagon-like peptide-1 (GLP-1) receptor agonist, alpha-glucosidase inhibitor, or rosiglitazone use concurrently or within 3 months prior to entry into the study
Severe hypoglycemia: have had more than one episode of severe hypoglycemia (defined as requiring assistance of a third party due to disabling hypoglycemia) within 6 months prior to entry into the study
Excessive insulin resistance: received a total daily dose of insulin greater than 2.0 units per kilogram (U/kg) at the time of randomization
Morbid obesity: defined as a body mass index greater than or equal to 45 kilograms per square meter (kg/m²)

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
Insulin lisproAlso: Humalog, LY275585Administered subcutaneously, up to three times daily for 24 weeks	Drug	3 Day Algorithm, Daily Algorithm
GlargineAdministered subcutaneously, dosage determined by investigator once daily for 24 weeks	Drug	3 Day Algorithm, Daily Algorithm

Primary outcome

Change From Baseline to 24 Week Endpoint in Glycated Hemoglobin (HbA1c)
Time frame: Baseline, 24 weeks
The change from baseline to 24 weeks in the percentage of HbA1c in plasma. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: fixed effects for treatment, country, sulfonylurea/meglitinide use, visit, treatment by visit interaction with baseline HbA1c as a covariate.

14 secondary outcomes

Percentage of Participants Achieving Glycated Hemoglobin (HbA1c) Target Values
Time frame: 24-week endpoint
Percentage of Participants ≥65 Years of Age Achieving Glycated Hemoglobin (HbA1c) Target Concentration
Time frame: 24-week endpoint
Change From Baseline to 24 Week Endpoint in Body Weight
Time frame: Baseline, 24-weeks
Time to Reach Glycated Hemoglobin (HbA1c) Target Values
Time frame: Baseline through 24 weeks
Change From Baseline to 24 Week Endpoint in Fasting Glucose
Time frame: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in Fasting Glucose in Participants ≥65 Years of Age
Time frame: Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in 1,5-anhydroglucitol (1,5-AG)
Time frame: Baseline, 24 weeks
Change From Baseline to 24 Weeks in 7-Point Self-Monitored Blood Glucose (SMBG) Profile
Time frame: Baseline, 24 weeks
Daily Dose of Insulin: Total, Basal and Prandial (Bolus)
Time frame: 24 weeks
Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial (Bolus)
Time frame: 24 weeks
The Number of Participants With a Hypoglycemic Episode (Incidence)
Time frame: Randomization through 24 weeks overall
The Number of Participants ≥65 Years of Age With Hypoglycemic Episodes (Incidence)
Time frame: Randomization through 24 weeks overall
The Rate of Hypoglycemic Episodes
Time frame: Randomization through 24 weeks overall
Percentage of Participants With Severe Hypoglycemic Episodes
Time frame: Randomization up to 24 weeks

Results and safety

Results posted to the registry on 27 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study A Q1D	268	223
Study A Q3D	263	210
Study B Q1D	292	244
Study B Q3D	294	241

Primary outcome: Change From Baseline to 24 Week Endpoint in Glycated Hemoglobin (HbA1c)

Time frame: Baseline, 24 weeks. Least squares mean (Standard Error). Unit: percentage HbA1c

Measure	Study A Q1D n = 267	Study A Q3D n = 261	Study B Q1D n = 288	Study B Q3D n = 290
Value	-1.00 (0.08)	-0.96 (0.08)	-0.98 (0.07)	-0.92 (0.07)

Study A Q1D vs Study A Q3D: LS Mean Difference: 0.04 (95% CI -0.15 to 0.22)
Study B Q1D vs Study B Q3D: LS Mean Difference: 0.06 (95% CI -0.12 to 0.24)

Population analysed: Full Analysis Set: All participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin with a baseline value for HbA1C, except participants from the excluded site.

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study A Q1D	21 of 268 (7.8%)	136 of 268 (50.7%)	Not reported
Study A Q3D	17 of 263 (6.5%)	142 of 263 (54%)	Not reported
Study B Q1D	21 of 289 (7.3%)	130 of 289 (45%)	Not reported
Study B Q3D	27 of 292 (9.2%)	150 of 292 (51.4%)	Not reported

Limitations and caveats (from the sponsor): Five (5) randomized participants (3 Study B Q1D, 2 Study B Q3D) from 1 site were excluded from efficacy and safety analyses due to quality issues and validity of the data at that site.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

76 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin lispro and Glargine in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 76 sites in 15 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 6 inclusion and 16 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 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Mexico, Puerto Rico, Poland, Argentina and 10 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 27 Feb 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 to 24 Week Endpoint in Glycated Hemoglobin (HbA1c) (time frame: Baseline, 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 NCT01215955.

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 23 Apr 2014.