|
Health Condition(s) or Problem
|
Diabetes Mellitus, Type 2
|
|
Lay Summary
|
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 night time 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
(from ClinicalTrials.gov)
|
|
Who can enter the trial
|
Inclusion Criteria:
- Have type 2 diabetes mellitus, not treated with insulin, for at least one year prior
to the study
- Have been receiving at least 2 oral antihyperglycemic medication for at least 3
months before entering the study
- Have hemoglobin A1c value between 7.0% and 11.0%, inclusive, at screening
- Are capable of, and willing to inject insulin with a vial and syringe and perform
self blood glucose monitoring
- Woman of Childbearing potential only: are not breastfeeding, have a negative
pregnancy test at the time of screening and randomization and intend to not become
pregnant during the trial. Have practiced a reliable method of birth control for at
least 6 weeks prior to screening and agree to use a reliable method of birth control
during the study and until 2 weeks following the last dose of study drug
Exclusion Criteria:
- Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except
for short-term treatment of acute conditions, and up to a maximum of 4 continuous
weeks
- Use of rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist
(for example, exenatide, exenatide once weekly, or liraglutide) concurrently or
within 3 months prior to screening
- Are currently taking, or have taken within the 3 months preceding screening,
medications to promote weight loss
- Have had any episodes of severe hypoglycemia within 6 months prior to screening
- Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the 6
months prior to the study
- 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)
- Have a history of renal transplantation, or are currently receiving renal dialysis or
have serum creatinine greater or equal than 2 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 at screening
- Have had a blood transfusion or severe blood loss within 3 months prior to screening
or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other
traits of hemoglobin abnormalities known to interfere with the measurement of
hemoglobin A1c
- Have active or untreated malignancy, have been in remission from clinically
significant malignancy for less than 5 years
- Have fasting or nonfasting triglycerides greater than 400 mg/dL (greater than 4.5
mmol/L) at screening
- Are using lipid lowering medication at a dose that has not been stable for 90 days
prior to screening
- Are using niacin preparations as a lipid lowering medication and bile acid
sequestrants within 90 days prior to screening
|
|
Who cannot enter the trial
|
Inclusion Criteria:
- Have type 2 diabetes mellitus, not treated with insulin, for at least one year prior
to the study
- Have been receiving at least 2 oral antihyperglycemic medication for at least 3
months before entering the study
- Have hemoglobin A1c value between 7.0% and 11.0%, inclusive, at screening
- Are capable of, and willing to inject insulin with a vial and syringe and perform
self blood glucose monitoring
- Woman of Childbearing potential only: are not breastfeeding, have a negative
pregnancy test at the time of screening and randomization and intend to not become
pregnant during the trial. Have practiced a reliable method of birth control for at
least 6 weeks prior to screening and agree to use a reliable method of birth control
during the study and until 2 weeks following the last dose of study drug
Exclusion Criteria:
- Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except
for short-term treatment of acute conditions, and up to a maximum of 4 continuous
weeks
- Use of rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist
(for example, exenatide, exenatide once weekly, or liraglutide) concurrently or
within 3 months prior to screening
- Are currently taking, or have taken within the 3 months preceding screening,
medications to promote weight loss
- Have had any episodes of severe hypoglycemia within 6 months prior to screening
- Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the 6
months prior to the study
- 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)
- Have a history of renal transplantation, or are currently receiving renal dialysis or
have serum creatinine greater or equal than 2 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 at screening
- Have had a blood transfusion or severe blood loss within 3 months prior to screening
or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other
traits of hemoglobin abnormalities known to interfere with the measurement of
hemoglobin A1c
- Have active or untreated malignancy, have been in remission from clinically
significant malignancy for less than 5 years
- Have fasting or nonfasting triglycerides greater than 400 mg/dL (greater than 4.5
mmol/L) at screening
- Are using lipid lowering medication at a dose that has not been stable for 90 days
prior to screening
- Are using niacin preparations as a lipid lowering medication and bile acid
sequestrants within 90 days prior to screening
|
|
What will happen
|
Drug; Glargine; Administered by subcutaneous injection; Glargine; Drug; LY2605541; Administered by subcutaneous injection; LY2605541
|
|
Primary aim
|
Change from baseline to 52 week endpoint in hemoglobin A1c (HbA1c)
|
|
Secondary Aim
|
Rate of total and nocturnal hypoglycemia events; 0 to 52 weeks; No; Percentage of patients with hemoglobin A1c equal or less than 6.5% and less than 7.0 %; 52 weeks; No; Fasting serum glucose (by laboratory measurement) and fasting blood glucose (by patient self monitored blood glucose readings); 52 weeks; No; 6 point self-monitored blood glucose (SMBG); 52 weeks; No; Change in Body weight; Baseline, 52 weeks; No; Hemoglobin A1c; 52 weeks; No; Insulin dose per Body Weight; 52 weeks; No; Number of Insulin Dose Adjustments to Steady-State; 0 to 26 weeks; No; European Quality of Life -5 dimension (EuroQol-5 dimension); 52 weeks; No; Insulin Treatment Satisfaction Questionnaire; 52 weeks; No; Adult Low Blood Sugar Survey; 52 weeks; No; Change in Triglycerides,Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C); Baseline, 52 weeks; Yes; Percentage of patients with equal or above 2-, and 3- fold upper limits of normal (ULN) for total bilirubin; 52 weeks; Yes; Change in Anti-LY2605541 Antibodies; Baseline, 52 weeks; Yes; Intra-patient variability of the Fasting Blood Glucose (FBG); 52 weeks; No; Incidence of total and nocturnal hypoglycemic events; 0 to 52 weeks; No; Percentage of patients with hemoglobin A1c equal or less than 6.5% and less than 7.0 % and without nocturnal hypoglycemia; 52 weeks; No; Percentage of patients with equal or above 2-, and 3-fold upper limits of normal (ULN) for Alanine transaminase (ALT/SGPT), aspartate transaminase (AST/SGOT); 52 weeks; Yes
|
|
Participant Information Sheet
|
Sorry, not currently available
|
|
Website
|
Sorry, not currently available
|
|
Recruitment Status
|
Not Recruiting
|
|
Nation
|
England, Wales
|
|
Location
|
Reading, Leicester, Guildford, Swansea
|