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Health Condition(s) or Problem
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Diabetes Mellitus, Type 2
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Lay Summary
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The purpose of this study is to determine if LY2189265 is as safe and effective in reducing
hemoglobin A1c (HbA1c) as compared to metformin in patients with Type 2 Diabetes.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Have type 2 diabetes for greater than or equal to 3 months and less than or equal to
5 years based on the disease diagnostic criteria (refer to the World Health
Organization's [WHO]Classification of Diabetes).
- Are treatment-naïve, not optimally controlled with diet and exercise alone, or are
taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding
thiazolidinediones).
- Are able and willing to tolerate a minimum dose of 1500 mg/day or up to 2000 mg/day
of metformin.
- Have HbA1c greater than or equal to 6.5% to less than or equal to 9.5%.
- Females of childbearing potential (not surgically sterilized and between menarche and
1-year postmenopausal) must: a)test negative for pregnancy at screening based on a
serum pregnancy test, and b)agree to use a reliable method of birth control during
the study and for 1 month following the last dose of study drug; or c)not be
breastfeeding.
- Have a stable weight (plus or minus 5%) greater than or equal to 3 months prior to
screening.
- Have a body mass index (BMI) between 23 and 45 kg/m2, inclusive.
- Are well-motivated, capable, and willing to: a)perform SMBG testing; b)learn how to
self-inject treatment (LY2189265 or placebo)and c)maintain a study diary.
Exclusion Criteria:
- You have type 1 diabetes mellitus
- You are being or have been treated with any of the following medications:
a)chronically treated with insulin for the treatment of diabetes in the past;
however, a short-term use of more than 3 months prior to screening is allowable,
b)GLP-1 analogs within 3 months prior to this screening, c)drugs to cause weight loss
within 3 months prior to screening, d)thiazolidinediones (TZDs)within 3 months prior
to screening, e)chronically treated(greater than or equal to 14 days) an oral
glucocorticoid or have received this type of therapy within 4 weeks prior to
screening,or f)illegal drugs.
- You have had 1 or more cases of uncontrolled diabetes which required hospitalization
in the 6 months prior to screening,
- You have a problem with your stomach or have chronically taken medication to increase
movement in your digestive tract or slow down the emptying of your digestive tract or
you have had gastric bypass (bariatric) surgery.
- You have had problems with your heart or brain in the past 2 months prior to
screening, such as a heart attack, chest pain, heart failure, heart bypass operation,
angioplasty or stent insertion,a heart rhythm problem, or a stroke.
- You have a serum creatinine result which shows a greater than or equal to 1.5 mg/dL
for men or greater than or equal to 1.4 mg/dL for women.
- You have a problem with your liver or pancreas.
- You have creatinine clearance result which shows less than 60 mL/minute, evidence of
a significant active, uncontrolled endocrine (hormone) or active autoimmune
abnormality.
- You have a serum calcitonin test and it shows a greater than or equal to 20 pcg/mL at
the time of screening.
- You have or have a family history of medullary C-cell hyperplasia or endocrine
neoplasia type 2A or type 2B.
- You have cancer (except for skin cancer) or have been in remission from cancer for
less than 5 years.
- You have had an organ transplant except for corneal transplant.
- You have received treatment within the last 30 days with a drug which has not been
regulator
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Who cannot enter the trial
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Inclusion Criteria:
- Have type 2 diabetes for greater than or equal to 3 months and less than or equal to
5 years based on the disease diagnostic criteria (refer to the World Health
Organization's [WHO]Classification of Diabetes).
- Are treatment-naïve, not optimally controlled with diet and exercise alone, or are
taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding
thiazolidinediones).
- Are able and willing to tolerate a minimum dose of 1500 mg/day or up to 2000 mg/day
of metformin.
- Have HbA1c greater than or equal to 6.5% to less than or equal to 9.5%.
- Females of childbearing potential (not surgically sterilized and between menarche and
1-year postmenopausal) must: a)test negative for pregnancy at screening based on a
serum pregnancy test, and b)agree to use a reliable method of birth control during
the study and for 1 month following the last dose of study drug; or c)not be
breastfeeding.
- Have a stable weight (plus or minus 5%) greater than or equal to 3 months prior to
screening.
- Have a body mass index (BMI) between 23 and 45 kg/m2, inclusive.
- Are well-motivated, capable, and willing to: a)perform SMBG testing; b)learn how to
self-inject treatment (LY2189265 or placebo)and c)maintain a study diary.
Exclusion Criteria:
- You have type 1 diabetes mellitus
- You are being or have been treated with any of the following medications:
a)chronically treated with insulin for the treatment of diabetes in the past;
however, a short-term use of more than 3 months prior to screening is allowable,
b)GLP-1 analogs within 3 months prior to this screening, c)drugs to cause weight loss
within 3 months prior to screening, d)thiazolidinediones (TZDs)within 3 months prior
to screening, e)chronically treated(greater than or equal to 14 days) an oral
glucocorticoid or have received this type of therapy within 4 weeks prior to
screening,or f)illegal drugs.
- You have had 1 or more cases of uncontrolled diabetes which required hospitalization
in the 6 months prior to screening,
- You have a problem with your stomach or have chronically taken medication to increase
movement in your digestive tract or slow down the emptying of your digestive tract or
you have had gastric bypass (bariatric) surgery.
- You have had problems with your heart or brain in the past 2 months prior to
screening, such as a heart attack, chest pain, heart failure, heart bypass operation,
angioplasty or stent insertion,a heart rhythm problem, or a stroke.
- You have a serum creatinine result which shows a greater than or equal to 1.5 mg/dL
for men or greater than or equal to 1.4 mg/dL for women.
- You have a problem with your liver or pancreas.
- You have creatinine clearance result which shows less than 60 mL/minute, evidence of
a significant active, uncontrolled endocrine (hormone) or active autoimmune
abnormality.
- You have a serum calcitonin test and it shows a greater than or equal to 20 pcg/mL at
the time of screening.
- You have or have a family history of medullary C-cell hyperplasia or endocrine
neoplasia type 2A or type 2B.
- You have cancer (except for skin cancer) or have been in remission from cancer for
less than 5 years.
- You have had an organ transplant except for corneal transplant.
- You have received treatment within the last 30 days with a drug which has not been
regulator
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What will happen
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Drug; Metformin; Administered orally, twice daily for 52 weeks; Metformin; Drug; LY2189265; Administered as subcutaneous injection, once weekly for 52 weeks; 1.5 mg LY2189265; 0.75 mg LY2189265; Dulaglutide; Drug; Placebo (oral); Administered orally, twice daily for 52 weeks; 1.5 mg LY2189265; 0.75 mg LY2189265; Drug; Placebo (subcutaneous); Administered as subcutaneous injection, once weekly for 52 weeks; Metformin
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Primary aim
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Change in HbA1c from baseline to 26 weeks endpoint (1.5mg LY2189265 compared to metformin)
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Secondary Aim
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Percentage of patients achieving an HbA1c of less than 7% and less than or equal to 6.5% at 26 and 52 weeks; 26 weeks, 52 weeks; No; Change from baseline to 26, and 52 weeks for blood glucose values from the 8-point self-monitored blood glucose (SMBG) profiles; Baseline, 26 weeks, 52 weeks; Yes; Change from baseline to 26, and 52 weeks in Homeostasis Model Assessment of beta-cell function; Baseline, 26 weeks, 52 weeks; No; Change from baseline to 26, and 52 weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) score; Baseline, 26 weeks, 52 weeks; No; Change from baseline to 26, and 52 weeks in the Impact of Weight on Self-Perception (IW-SP) score; Baseline, 26 weeks, 52 weeks; No; Change from baseline to 26, and 52 weeks in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) score; Baseline, 26 weeks, 52 weeks; No; Change from baseline to 26, and 52 weeks in the Diabetes Symptoms Checklist patient-reported outcome (DSC-r) score; Baseline, 26 weeks, 52 weeks; No; Anti-LY2189265 antibodies; 26 weeks, 52 weeks; Yes; Change from baseline to 26, and 52 weeks on electrocardiogram parameters; Baseline, 26 weeks, 52 weeks; Yes; Change from baseline to 26, and 52 weeks on pulse rate; Baseline, 26 weeks, 52 weeks; Yes; Change from baseline to 26, and 52 weeks on blood pressure; Baseline, 26 weeks, 52 weeks; Yes; Number of self-reported hypoglycemic events at 26 and 52 weeks; 26 weeks, 52 weeks; Yes; Change from baseline to 26, and 52 weeks on cholesterol; Baseline, 26 weeks, 52 weeks; Yes; Number of Treatment Emergent Adverse events at 26 and 52 weeks; 26 weeks, 52 weeks; Yes; Change from baseline to 26, and 52 weeks in body weight; Baseline, 26 weeks, 52 weeks; Yes; Change from baseline to 26, and 52 weeks in pancreatic enzymes; Baseline, 26 weeks, 52 weeks; Yes; Change from baseline to 26, and 52 weeks in serum calcitonin; Baseline, 26 weeks, 52 weeks; Yes; Pharmacokinetics - LY2189265 concentration; 26 weeks and 52 weeks; Yes; Change from baseline to 26 and 52 weeks in fasting blood glucose; Baseline, 26 weeks, 52 weeks; Yes; Change from baseline to 26, 52 weeks endpoint in HbA1c; Baseline, 26 weeks, 52 weeks; No; Change from baseline to 26, and 52 weeks on body mass index (BMI); Baseline, 26 weeks, 52 weeks; No; Change from baseline to 26, and 52 weeks on HDL; Baseline, 26 weeks, 52 weeks; Yes; Change from baseline to 26, and 52 weeks on LDL; Baseline, 26 weeks, 52 weeks; Yes; Change from baseline to 26, and 52 weeks on triglycerides; Baseline, 26 weeks, 52 weeks; Yes
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Completed
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Nation
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England
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Location
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Penzance, Durham, London, Thornton-cleveleys, Crawley, Nottingham
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