Effects of LY2189265 on Glycemic Control in Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2189265 and Lifestyle Measures; Placebo solution and Lifestyle Measures
Intervention description: Subcutaneous injection once-weekly for up to 12 weeks; Subcutaneous injection once-weekly for up to 12 weeks
Intervention MeSH terms: Dulaglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetes, type 2 diabetes

Summary:

      This is a study to demonstrate that different doses of once-weekly LY2189265 injected
      subcutaneously will have dose proportional effect on hemoglobin A1c (HbA1c) at 12 weeks in
      participants with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetes mellitus, type 2

          -  Treatment regimens: diet and exercise only or are taking metformin as monotherapy and
             are willing to discontinue this medication

          -  Have completed at least 8 weeks of wash-out prior to randomization (if on metformin
             therapy at screening)

          -  Have a qualifying glycosylated hemoglobin (HbA1c) value, as determined by the central
             laboratory: at screening (for diet and exercise only ≥7.0% to ≤9.5%; for metformin
             monotherapy >6.5% to ≤9.0%) and at time of randomization for all participants ≥6.5% to
             ≤9.5%

          -  Females of childbearing potential must test negative for pregnancy and agree to use a
             reliable birth control method

          -  Have a body mass index (BMI) between 23 and 40 kilograms/meter squared (kg/m^2),
             inclusive, for participants who are native to, and reside in, South and/or East Asia;
             all other participants must have a BMI between 25 and 40 kg/m^2, inclusive.

          -  Stable weight for 3 months prior to screening

        Exclusion Criteria:

          -  Diabetes mellitus, type 1

          -  Taking any glucose-lowering oral agents other than metformin within 3 months prior to
             screening

          -  Use of glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months
             prior to screening or being treated within insulin (with the exception of short-term
             management of acute conditions that occurred more than 3 months immediately prior to
             screening)

          -  Use of medications (prescription or over-the counter) to promote weight loss

          -  Chronic (>2 weeks) use of systemic glucocorticoid therapy

          -  Gastric emptying abnormality, history of bariatric surgery or chronic use of drugs
             that affect gastrointestinal motility

          -  Use of central nervous system (CNS) stimulant (for example, Ritalin-sustained release
             [SR])

          -  Cardiovascular event within 6 months prior to screening

          -  Poorly controlled hypertension (determined by a mean seated systolic blood pressure
             (BP) ≥160 millimeters of mercury (mmHg) or mean seated diastolic BP ≥95 mmHg at
             screening or randomization)

          -  Electrocardiogram (ECG) reading considered outside the normal limits by the
             investigator and relevant for interpretation or indicating cardiac disease

          -  Liver disease, hepatitis, chronic hepatitis, or alanine transaminase levels >3.0 times
             upper limit of normal

          -  Clinical signs or symptoms of pancreatitis or history of chronic or acute pancreatitis
             at time of screening

          -  Amylase ≥3 times the upper limit of normal and/or lipase ≥2 times upper limit of
             normal which are determined by central labs at the time of screening

          -  Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) for men or ≥1.4 mg/dL for women
             or a creatinine clearance <60 milliliter (mL)/minute which are determined by central
             labs at the time of screening

          -  Uncontrolled diabetes (defined as 2 or more episode of hyperosmolar state requiring
             hospitalization in the 6 months prior to screening)

          -  Significant active, uncontrolled endocrine or autoimmune abnormality

          -  History of a transplanted organ (corneal transplants are allowed)

          -  Active or untreated 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 any other condition, in the opinion of the investigator, that may preclude the
             participant from following or completing the protocol

          -  Investigator site personnel directly affiliated with this study and/or their immediate
             families (spouse, parent, child, or sibling, whether biological or legally adopted)

          -  Sponsor employees

          -  Received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of study entry

          -  Participated in an interventional medical, surgical, or pharmaceutical study within 30
             days prior to entry into the study

          -  Have previously completed or withdrawn from this study after providing informed
             consent