ot Applicable

• Conditions: type 2 diabetes; MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2010-021516-42-LT
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-26
• Last Update Posted: 11 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1096

Inclusion Criteria

[1] Have type 2 diabetes (per World Health Organization [WHO] Classification
of Diabetes).
[2] Are =18 and =85 years of age at the time of Visit 1.
[3] Have been treated for at least 90 days with insulin (glargine, NPH, NPL, 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 [sitagliptin only]) and, in the opinion of the
investigator, requires further intensification of therapy.
[4] Are treated with insulin (glargine, NPH, NPL or detemir) at least 20 U/day at
study entry.
[5] Have an HbA1c value >7.0% and =12.0% according to the central laboratory
at Visit 1 or Visit 6.
Note: for patients who enter the study on NPH, NPL or detemir, BID glargine; or on QD glargine with HbA1c >7.0% and fasting blood glucose >120 mg/dL, a 6-week
lead-in period will be required for glargine optimization. For a patient on QD
glargine with HbA1c >7.0% and fasting blood glucose =120 mg/dL, no leadin
period is required and he or she may be randomized at Visit 2.(The FBG measurements are based upon the 3 morning BG measurements from the 7-point SMBG profiles collected on 3 days prior to Visit 2.)
[6] Capable of, and willing, to do the following: inject insulin with a prefilled
pen and perform self blood glucose monitoring and record keeping as required
by this protocol, as determined by the investigator.
[7] Have given written informed consent to participate in this study in accordance
with local regulations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[8] Prior rapid- or short-acting insulin therapy: patients 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. Patients who have previously received short- or rapid-acting insulin as part of short-term
insulin therapy (during gestational diabetes, or 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.
[9] Concomitant medications: glucagon-like peptide-1 (GLP-1) receptor
agonist (e.g., exenatide or liraglutide), alpha-glucosidase inhibitor (e.g.,
acarbose, miglitol, or voglibose), DPP-4 inhibitors other than sitagliptin or rosiglitazone use concurrently or within 3 months prior to entry into study.
[10] 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.
[11] Excessive insulin resistance: received a total daily dose of insulin >2.0 U/kg
at the time of randomization.
[12] Morbid obesity: defined as a body mass index =45 kg/m2.
[13] 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
[14] Cardiovascular: have cardiac disease with functional status that is New
York Heart Association Class III or IV (per New York Heart Association
[NYHA] Cardiac Disease Classification) 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.
[15] Renal: have a history of renal transplantation or are currently receiving renal
dialysis or have serum creatinine =2 mg/dL if not on metformin.
[16] Hepatic: have obvious clinical signs or symptoms of liver disease, acute or
chronic hepatitis, or alanine aminotransferase (ALT)/serum glutamic pyruvic
transaminase (SGPT) >3x the upper limit of the reference range as defined by
the central laboratory.
[17] Hematologic: have known hemoglobinopathy or chronic anemia or other
known blood disorder.
[18] 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.
[19] Allergy: have known allergy to insulin lispro, insulin glargine, or excipients
contained in these products.
[20] 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 Visit 1.
[21] Adherence to protocol: have any other condition (including known drug or
alcohol abuse or psychiatric disorder) that precludes the patient from
following and completing the protocol.
[22] Prior participation: are currently enrolled in, or have participated in, an
interventional medical, surgical, or pharmaceutical drug or device or off-label
use

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified