A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3) | Completed
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3)
Health Conditions
  • Diabetes Mellitus, Type 2
Completed
Recruitment Status
NCT01126580
Primary Trial ID Number
Summary
The purpose of this study is to determine if LY2189265 is safe and effective in reducing glycosylated hemoglobin (HbA1c) as compared to metformin in participants with Type 2 Diabetes.
Primary Outcome Measures
  • Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c); Baseline, 26 weeks
Secondary Outcome Measures
  • Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c); Baseline, 52 weeks; Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of Less Than 7% and Less Than or Equal to 6.5% at 26 and 52 Weeks; 26 weeks and 52 weeks; Change From Baseline to 26 and 52 Weeks in Fasting Blood Glucose; Baseline, 26 weeks, and 52 weeks; Change From Baseline to 26 and 52 Weeks in Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles; Baseline, 26 weeks, and 52 weeks; Change From Baseline to 26 and 52 Weeks in Body Weight; Baseline, 26 weeks, and 52 weeks; Change From Baseline to 26 and 52 Weeks in Body Mass Index (BMI); Baseline, 26 weeks, and 52 weeks; Change From Baseline to 26 and 52 Weeks in Homeostasis Model Assessment of Beta-cell Function; Baseline, 26 weeks, and 52 weeks; Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) Score; Baseline, 26 weeks, and 52 weeks; Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) Score; Baseline, 26 weeks, and 52 weeks; Change From Baseline to 26 and 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Status Version; Baseline, 26 weeks, and 52 weeks; Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Change Version; 52 weeks; Change From Baseline to 26 and 52 Weeks in the Diabetes Symptoms Checklist Participant-reported Outcome (DSC-r) Score; Baseline, 26 weeks, and 52 weeks; Number of Participants With Treatment Emergent Adverse Events at 26 and 52 Weeks; 26 weeks and 52 weeks; Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval; Baseline, 26 weeks, and 52 weeks; Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate; Baseline, 26 weeks, and 52 weeks; Change From Baseline to 26 and 52 Weeks in Pulse Rate; Baseline, 26 weeks, and 52 weeks; Change From Baseline to 26 and 52 Weeks in Blood Pressure; Baseline, 26 weeks, and 52 weeks; Percent Change From Baseline to 26 and 52 Weeks in Total Cholesterol; Baseline, 26 weeks, and 52 weeks; Percentage Change From Baseline to 26 and 52 Weeks in High Density Lipoprotein Cholesterol (HDL-C); Baseline, 26 weeks, and 52 weeks; Percentage Change From Baseline to 26 and 52 Weeks in Low Density Lipoprotein Cholesterol (LDL-C); Baseline, 26 weeks, and 52 weeks; Percentage Change From Baseline to 26 and 52 Weeks in Triglycerides; Baseline, 26 weeks, and 52 weeks; Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes; Baseline, 26 weeks, and 52 weeks; Change From Baseline to 26 and 52 Weeks in Serum Calcitonin; Baseline, 26 weeks, and 52 weeks; Number of Participants With Treatment Emergent Anti-LY2189265 Antibodies; Baseline through 52 weeks; Number of Self-reported Hypoglycemic Events at 26 and 52 Weeks; Baseline through 26 weeks and 52 weeks; Rate of Self-reported Hypoglycemic Events at 52 Weeks; Baseline through 52 weeks; Number of Participants With Adjudicated Pancreatitis at 52 Weeks Plus 30-day Follow up; Baseline through 52 weeks plus 30-day follow up; Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks Plus 30-day Follow up; Baseline through 52 weeks plus 30-day follow up; Measurement of LY2189265 Drug Concentration for Pharmacokinetics: Area Under the Concentration Curve (AUC); 4 weeks, 13 weeks, 26 weeks, and 52 weeks
Research Question
  • The purpose of this study is to determine if LY2189265 is safe and effective in reducing glycosylated hemoglobin (HbA1c) as compared to metformin in participants with Type 2 Diabetes.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
Sorry, this information is not available
Countries of Recruitment
United States; Argentina; Brazil; Canada; Croatia; Czech Republic; Finland; France; Germany; India; Korea, Republic of; Mexico; Poland; Puerto Rico; Romania; Slovakia; South Africa; Spain; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion Criteria
  • 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). For those on 1 OAM, the dose must be less than or equal to 50%
  • the maximum authorized per local label.
  • - Are able and willing to tolerate a minimum dose of 1500 milligrams per day (mg/day)
  • or up to 2000 mg/day of metformin.
  • - Have glycosylated hemoglobin (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 kilograms per square meter (kg/m^2),
  • inclusive.
  • - Are well-motivated, capable, and willing to: a) perform self-monitored blood glucose
  • (SMBG) testing; b) learn how to self-inject treatment (LY2189265 or placebo) and c)
  • maintain a study diary.
  • Exclusion Criteria:
  • - Have type 1 diabetes mellitus.
  • - 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 insulin more than 3 months prior to screening is allowable, b) glucagon-like
  • peptide 1 (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)
  • with an oral glucocorticoid or have received this type of therapy within 4 weeks
  • prior to screening, or f) illegal drugs.
  • - Have had 1 or more cases of uncontrolled diabetes that required hospitalization in
  • the 6 months prior to screening.
  • - Have stomach problems, have chronically taken medication to increase movement in the
  • digestive tract or slow down the emptying of the digestive tract, or have had gastric
  • bypass (bariatric) surgery.
  • - Have had problems with the 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.
  • - Have a serum creatinine result which shows a greater than or equal to 1.5 milligrams
  • per deciliter (mg/dL) for men or greater than or equal to 1.4 mg/dL for women.
  • - Have a problem with the liver or pancreas.
  • - Have a creatinine clearance result which shows less than 60 milliliters per minute
  • (mL/min), evidence of a significant active, uncontrolled endocrine (hormone), or
  • active autoimmune abnormality.
  • - Have a serum calcitonin test which shows greater than or equal to 20 picograms per
  • milliliter (pcg/mL) at the time of screening.
  • - Have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A
  • or type 2B.
  • - Have cancer (except for skin cancer) or have been in remission from cancer for less
  • than 5 years.
  • - Have had an organ transplant except for corneal transplant.
  • - Have received treatment within the last 30 days with a drug which has not been
  • regulatory approved.
  • - Have participated in a medical, surgical, or pharmaceutical study where these types
  • of procedures were performed within 30 days prior to screening.
  • - Have any condition that is a contraindication to or would interfere with medications
  • provided for this study to treat diabetes.
  • - Have a blood disorder that would interfere with the drawing of blood glucose
  • measurements or lab samples.
  • - Have previously participated or signed an informed consent document for this same
  • type of study and study drug.
Participant Exclusion Criteria
  • 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). For those on 1 OAM, the dose must be less than or equal to 50%
  • the maximum authorized per local label.
  • - Are able and willing to tolerate a minimum dose of 1500 milligrams per day (mg/day)
  • or up to 2000 mg/day of metformin.
  • - Have glycosylated hemoglobin (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 kilograms per square meter (kg/m^2),
  • inclusive.
  • - Are well-motivated, capable, and willing to: a) perform self-monitored blood glucose
  • (SMBG) testing; b) learn how to self-inject treatment (LY2189265 or placebo) and c)
  • maintain a study diary.
  • Exclusion Criteria:
  • - Have type 1 diabetes mellitus.
  • - 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 insulin more than 3 months prior to screening is allowable, b) glucagon-like
  • peptide 1 (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)
  • with an oral glucocorticoid or have received this type of therapy within 4 weeks
  • prior to screening, or f) illegal drugs.
  • - Have had 1 or more cases of uncontrolled diabetes that required hospitalization in
  • the 6 months prior to screening.
  • - Have stomach problems, have chronically taken medication to increase movement in the
  • digestive tract or slow down the emptying of the digestive tract, or have had gastric
  • bypass (bariatric) surgery.
  • - Have had problems with the 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.
  • - Have a serum creatinine result which shows a greater than or equal to 1.5 milligrams
  • per deciliter (mg/dL) for men or greater than or equal to 1.4 mg/dL for women.
  • - Have a problem with the liver or pancreas.
  • - Have a creatinine clearance result which shows less than 60 milliliters per minute
  • (mL/min), evidence of a significant active, uncontrolled endocrine (hormone), or
  • active autoimmune abnormality.
  • - Have a serum calcitonin test which shows greater than or equal to 20 picograms per
  • milliliter (pcg/mL) at the time of screening.
  • - Have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A
  • or type 2B.
  • - Have cancer (except for skin cancer) or have been in remission from cancer for less
  • than 5 years.
  • - Have had an organ transplant except for corneal transplant.
  • - Have received treatment within the last 30 days with a drug which has not been
  • regulatory approved.
  • - Have participated in a medical, surgical, or pharmaceutical study where these types
  • of procedures were performed within 30 days prior to screening.
  • - Have any condition that is a contraindication to or would interfere with medications
  • provided for this study to treat diabetes.
  • - Have a blood disorder that would interfere with the drawing of blood glucose
  • measurements or lab samples.
  • - Have previously participated or signed an informed consent document for this same
  • type of study and study drug.
Interventions
Drug; Metformin; null; [Metformin]; Drug; LY2189265; null; [1.5 mg LY2189265, 0.75 mg LY2189265]; Drug; Placebo (oral); null; [1.5 mg LY2189265, 0.75 mg LY2189265]; Drug; Placebo (subcutaneous); null; [Metformin]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
Sorry, this information is not available
Scientific Title
The Impact of LY2189265 Versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3)
Secondary Trial Identifying Number
H9X-MC-GBDC; CTRI/2010/091/003036
Website
Sorry, this information is not available
Study Funded By
Eli Lilly and Company
Funder Type
Sorry, this information is not available
Study Sponsored By
Eli Lilly and Company
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

18 May 2010

Last Updated

15 Jan 2015

Date Record Refreshed on UKCTG

31 Jul 2015