A Study in Patients With Type I Diabetes Mellitus



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:January 2012
End Date:December 2013
Contact:There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or
Phone:1-317-615-4559

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The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: a Double-Blind, Randomized, 52-week Study


The purpose of this study is:

- To compare the blood sugar control on LY2605541 with insulin glargine after 52 weeks of
treatment.

- To compare the number of nocturnal low blood sugar episodes on LY2605541 with insulin
glargine during 52 weeks of treatment.

- To compare the number of patients on LY2605541 reaching blood sugar targets without low
blood sugar episodes at night to those taking insulin glargine after 52 weeks of
treatment.

- To compare the total number of low blood sugar episodes on LY2605541 with insulin
glargine after 52 weeks of treatment


Inclusion Criteria:

- Type 1 diabetes for at least 1 year

- HbA1c value less than 12 percent according to the central laboratory at screening

- body mass index of less than or equal to 35.0 kg/m^2

- Have been treated for at least 90 days prior to screening with

- insulin detemir, insulin glargine, or Neutral Protamine Hagedorn (NPH)in
combination with pre-meal insulin, or

- self mixed or pre-mixed insulin regimens with any basal and bolus insulin
combination administered at least twice daily, or

- continuous subcutaneous insulin infusion therapy

- Women who are not breast feeding and test negative for pregnancy before receiving
treatment and agree to use reliable birth control until 4 weeks after last treatment
with study drug

- Are capable and willing to adhere to multiple daily injections, inject with a vial
and syringe and prefilled pen and perform self monitored blood glucose readings and
record keeping

Exclusion Criteria:

- Are using twice daily insulin glargine having been inadequately controlled on single
daily dose of glargine prior to screening

- Excessive insulin resistance defined as having received a total daily dose of insulin
greater than 1.5 U/kg at the time of randomization

- Receiving any oral or injectable medication (other than insulins or metformin for
treatment of polycystic ovarian disease) intended for the treatment of diabetes
mellitus in the 90 days prior to screening

- Lipid lowering medications:

- are using niacin preparations as lipid lowering medication and/or bile acid
sequestrants within 90 days prior to screening; or,

- are using lipid lowering medication at a dose that has not been stable for 90
days or more prior to screening

- Have fasting hypertriglyceridemia (defined as greater than 4.5 mmol/L, greater
than 400 mg/dl) at screening, as determined by the central laboratory.

- Have had more than 1 episode of severe hypoglycemia within 6 months prior to
screening

- Have had 2 or more emergency room visits or hospitalizations due to poor glucose
control within 6 months prior to screening

- Have cardiac disease with functional status that is New York Heart Association
Class III or IV

- Have a history of renal transplantation or are currently receiving renal
dialysis or have serum creatinine greater than 2.5 mg/dL

- Have obvious clinical signs or symptoms of liver disease (excluding
non-alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non
alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements as
indicated below:

- total bilirubin 2 times or more than the upper limit of normal (ULN) as defined
by the central laboratory, or

- alanine aminotransferase (ALT)/(serum glutamic pyruvic transaminase (SGPT) more
than 2.5 times ULN as defined by the central laboratory, or

- aspartate aminotransferase (AST)/(serum glutamic oxaloacetic transaminase (SGOT)
more than 2.5 times ULN as defined by the central laboratory

- 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 increased risk for developing cancer or a
recurrence of cancer

- Diagnosed clinically significant diabetic autonomic neuropathy
We found this trial at
27
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Chapel Hill, North Carolina 27599
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Charleston, South Carolina 29425
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