Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
PHASE2
Total Enrollment
240 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-09-30
Study Completion Date
2012-09-30
Brief Summary
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The study is designed to see if once daily oral dosing of LY2608204 will help control diabetes as measured by the glycosylated fraction of hemoglobin A (HbA1c) level. It will also help to determine the safety of the medication and the most useful doses of the medication.
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Detailed Description
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Conditions
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Diabetes Mellitus, Type 2
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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LY2608204
80 to 400 mg, Doses will be titrated to reach glycemic targets during the first 4 weeks. The starting dose level depends on the participant's HbA1c level measured at Screening. Administered orally, daily for 12 weeks
Group Type
EXPERIMENTAL
LY2608204
Intervention Type
DRUG
Administered orally
Glimepiride
1 to 6 mg, Doses will be titrated to reach glycemic targets during the first 4 weeks. Administered orally, daily for 12 weeks
Group Type
ACTIVE_COMPARATOR
Glimepiride
Intervention Type
DRUG
Administered orally
Interventions
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LY2608204
Administered orally
Intervention Type
DRUG
Glimepiride
Administered orally
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of type 2 diabetes mellitus prior to entering the trial
* May be treated with:
1. Diet and exercise alone or
2. Diet and exercise in combination with a stable dose of metformin for at least 3 months before Screening or
3. Diet and exercise in combination with a stable dose of sulfonylurea or meglitinide (repaglinide, nateglinide) for at least 3 months before Screening or
4. Diet and exercise in combination with stable doses of metformin and sulfonylurea or metformin and meglitinides for at least 3 months before Screening and have had diabetes for at least 6 years
* Must have an Hemoglobin A1c value between 7% and 10%
* Must have a body mass index (BMI) between 20 and 40 kg/m2
* Must have stable weight during the 3 months prior to Screening (weight change not to exceed 5 kg (11 lb))
* If female, you must not be able to get pregnant
* Must be well motivated, capable, and willing to complete study required glucose monitoring and instruction
* May be treated with:
1. Diet and exercise alone or
2. Diet and exercise in combination with a stable dose of metformin for at least 3 months before Screening or
3. Diet and exercise in combination with a stable dose of sulfonylurea or meglitinide (repaglinide, nateglinide) for at least 3 months before Screening or
4. Diet and exercise in combination with stable doses of metformin and sulfonylurea or metformin and meglitinides for at least 3 months before Screening and have had diabetes for at least 6 years
* Must have an Hemoglobin A1c value between 7% and 10%
* Must have a body mass index (BMI) between 20 and 40 kg/m2
* Must have stable weight during the 3 months prior to Screening (weight change not to exceed 5 kg (11 lb))
* If female, you must not be able to get pregnant
* Must be well motivated, capable, and willing to complete study required glucose monitoring and instruction
Exclusion Criteria
* Use of insulin or any antidiabetic agent other than metformin or sulfonylurea or meglitinide during the 3 months prior to Screening
* Have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone gastric bypass or gastric banding surgery
* Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness or have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
* Are currently taking or have taken within the last 2 months, prescription or over-the counter medications which affect body weight
* Have cardiac disease with functional status that is New York Heart Association \[NYHA\] Class II, III, or IV or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 months.
* Have poorly controlled hypertension, history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days before randomization
* Have a QTcB (Bazett's-corrected QT interval) interval greater than 450 msec for men or greater than 470 for women at Screening or any personal history of ventricular tachycardia or unexplained syncope
* Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or significantly elevated liver blood tests
* Are currently receiving renal dialysis, have a serum creatinine greater than 2.0 mg/dL (177 μmol/L) or a calculated creatinine clearance of less than 60 ml/min or in patients being treated with metformin, have other known contradictions to metformin use including, but not limited to, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product label
* Have fasting state hypertriglyceridemia (defined as greater than 5.65 mmol/L, 500 mg/dl) at Screening. If taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
* Are receiving chronic (for more than 2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to Randomization
* Have an active or untreated malignancy or have been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
* Have a history of seizure disorder
* Are currently using or intend to use inhibitors of Cytochrome P450 family 3A (CYP3A4)
* Currently taking a medication that is a sensitive substrate of the CYP3A4 pathway with a narrow therapeutic index
* Have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone gastric bypass or gastric banding surgery
* Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness or have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
* Are currently taking or have taken within the last 2 months, prescription or over-the counter medications which affect body weight
* Have cardiac disease with functional status that is New York Heart Association \[NYHA\] Class II, III, or IV or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 months.
* Have poorly controlled hypertension, history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days before randomization
* Have a QTcB (Bazett's-corrected QT interval) interval greater than 450 msec for men or greater than 470 for women at Screening or any personal history of ventricular tachycardia or unexplained syncope
* Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or significantly elevated liver blood tests
* Are currently receiving renal dialysis, have a serum creatinine greater than 2.0 mg/dL (177 μmol/L) or a calculated creatinine clearance of less than 60 ml/min or in patients being treated with metformin, have other known contradictions to metformin use including, but not limited to, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product label
* Have fasting state hypertriglyceridemia (defined as greater than 5.65 mmol/L, 500 mg/dl) at Screening. If taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
* Are receiving chronic (for more than 2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to Randomization
* Have an active or untreated malignancy or have been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
* Have a history of seizure disorder
* Are currently using or intend to use inhibitors of Cytochrome P450 family 3A (CYP3A4)
* Currently taking a medication that is a sensitive substrate of the CYP3A4 pathway with a narrow therapeutic index
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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.
Anaheim, California, United States
Site Status
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Lancaster, California, United States
Site Status
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Spring Valley, California, United States
Site Status
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Hollywood, Florida, United States
Site Status
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Jacksonville, Florida, United States
Site Status
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West Palm Beach, Florida, United States
Site Status
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Des Moines, Iowa, United States
Site Status
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Topeka, Kansas, United States
Site Status
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Metairie, Louisiana, United States
Site Status
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Shreveport, Louisiana, United States
Site Status
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Royal Oak, Michigan, United States
Site Status
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St Louis, Missouri, United States
Site Status
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Beachwood, Ohio, United States
Site Status
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Perrysburg, Ohio, United States
Site Status
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Dallas, Texas, United States
Site Status
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Hurst, Texas, United States
Site Status
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Plano, Texas, United States
Site Status
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San Antonio, Texas, United States
Site Status
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Graz, , Austria
Site Status
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Vienna, , Austria
Site Status
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Vorarlberg, , Austria
Site Status
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Prague, , Czechia
Site Status
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Bad Mergentheim, , Germany
Site Status
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Bad Oeynhausen, , Germany
Site Status
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Berlin, , Germany
Site Status
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Giengen an der Brenz, , Germany
Site Status
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Mainz, , Germany
Site Status
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Münster, , Germany
Site Status
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Gdynia, , Poland
Site Status
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Lodz, , Poland
Site Status
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Chelyabinsk, , Russia
Site Status
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Moscow, , Russia
Site Status
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Saint Petersburg, , Russia
Site Status
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Alicante, , Spain
Site Status
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Alzira, , Spain
Site Status
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Barcelona, , Spain
Site Status
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Petrel, , Spain
Site Status
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Seville, , Spain
Site Status
Countries
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United States
Austria
Czechia
Germany
Poland
Russia
Spain
Other Identifiers
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I3P-MC-GKBC
Identifier Type: OTHER
Identifier Source: secondary_id
14090
Identifier Type: -
Identifier Source: org_study_id
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