NCT01215955

Brief 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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,117

participants targeted

Target at P75+ for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2010

Typical duration for phase_4 diabetes-mellitus-type-2

Geographic Reach
15 countries

76 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 27, 2014

Completed
Last Updated

April 23, 2014

Status Verified

April 1, 2014

Enrollment Period

2.1 years

First QC Date

September 30, 2010

Results QC Date

January 9, 2014

Last Update Submit

April 3, 2014

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 DiabetesInsulinAlgorithmsBlood glucose levels

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 24 weeks

Secondary Outcomes (14)

  • Percentage of Participants Achieving Glycated Hemoglobin (HbA1c) Target Values

    24-week endpoint

  • Percentage of Participants ≥65 Years of Age Achieving Glycated Hemoglobin (HbA1c) Target Concentration

    24-week endpoint

  • Change From Baseline to 24 Week Endpoint in Body Weight

    Baseline, 24-weeks

  • Time to Reach Glycated Hemoglobin (HbA1c) Target Values

    Baseline through 24 weeks

  • Change From Baseline to 24 Week Endpoint in Fasting Glucose

    Baseline, 24 weeks

  • +9 more secondary outcomes

Study Arms (2)

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)

Drug: Insulin lisproDrug: 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)

Drug: Insulin lisproDrug: Glargine

Interventions

Insulin lisproDRUG

Administered subcutaneously, up to three times daily for 24 weeks

Also known as: Humalog, LY275585
3 Day AlgorithmDaily Algorithm
GlargineDRUG

Administered subcutaneously, dosage determined by investigator once daily for 24 weeks

3 Day AlgorithmDaily Algorithm

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (76)

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Phoenix, Arizona, 85050, United States

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Concord, California, 94520, United States

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Fresno, California, 93720, United States

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Lakewood, California, 90712, United States

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Lancaster, California, 93534, United States

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Mission Hills, California, 91345, United States

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Tustin, California, 92780, United States

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Bradenton, Florida, 34208, United States

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Jacksonville, Florida, 32209, United States

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Orlando, Florida, 32806, United States

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Pembroke Pines, Florida, 33027, United States

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Idaho Falls, Idaho, 83404, United States

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Lewiston, Idaho, 83501, United States

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Evansville, Indiana, 47714, United States

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Des Moines, Iowa, 50314, United States

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Topeka, Kansas, 66606, United States

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Lexington, Kentucky, 40503, United States

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Metairie, Louisiana, 70006, United States

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Shreveport, Louisiana, 71106, United States

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Haverhill, Massachusetts, 01830, United States

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Troy, Michigan, 48085, United States

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Minneapolis, Minnesota, 55416, United States

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Clarkson Valley, Missouri, 63011, United States

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Las Vegas, Nevada, 89119, United States

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Flemington, New Jersey, 08822, United States

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Syracuse, New York, 13210, United States

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Dayton, Ohio, 45439, United States

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Portland, Oregon, 97210, United States

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Beaver, Pennsylvania, 15009, United States

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Philadelphia, Pennsylvania, 19107, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77095, United States

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San Antonio, Texas, 78229, United States

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Buenos Aires, C1425AGC, Argentina

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Mar del Plata, B7600FZN, Argentina

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Rosario, 2000, Argentina

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Vienna, 1130, Austria

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Belém, 66073-000, Brazil

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Curitiba, 80060-900, Brazil

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Maringá, 87015-320, Brazil

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Winnipeg, Manitoba, R3E 3P4, Canada

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Charlottetown, Prince Edward Island, C1A 1L2, Canada

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Sherbrooke, Quebec, J1G 2E9, Canada

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Osijek, 31000, Croatia

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Slavonski Brod, 35 000, Croatia

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Zagreb, 10000, Croatia

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Copenhagen, 2400, Denmark

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Frederiksberg, 2000, Denmark

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Kolding, 6000, Denmark

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Bourges, 18000, France

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La Bouëxière, 35340, France

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Nantes, 44300, France

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Kaunas, LT-51270, Lithuania

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Raseiniai, 60127, Lithuania

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Ukmerge, 20184, Lithuania

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Cuauhtémoc, 06090, Mexico

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Guadalajara, 44150, Mexico

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Guadalajara Jalisco, 04460, Mexico

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Mexico City, 03300, Mexico

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Monterrey, 64710, Mexico

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Lodz, 90-242, Poland

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Lublin, 20-538, Poland

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Poznan, 61-655, Poland

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Szczecin, 70-506, Poland

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Caguas, 00726, Puerto Rico

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Manatí, 00674, Puerto Rico

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Ponce, 007171563, Puerto Rico

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Rio Piedras, 00921, Puerto Rico

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San Juan, 00917, Puerto Rico

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Bucharest, 022441, Romania

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Oradea, 410169, Romania

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Saint Petersburg, 197022, Russia

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Saratov, 410053, Russia

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Stavropol, 355035, Russia

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Halfway House, 1685, South Africa

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Somerset West, 7130, South Africa

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

Insulin LisproInsulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Long-Acting

Limitations and Caveats

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.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2010

First Posted

October 7, 2010

Study Start

December 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

April 23, 2014

Results First Posted

February 27, 2014

Record last verified: 2014-04

Locations

RU(3)BR(3)PL(4)ME(5)DK(3)AU(1)LI(3)US(33)CA(3)ZA(2)RO(2)FR(3)PR(5)AR(3)CR(3)