A Study of Dose Titration of LY2189265 in Overweight Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Intervention: LY2189265; Placebo
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: 262.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To study once weekly injections of LY2189265 compared to placebo on blood glucose by
      measuring glycosylated hemoglobin (HbA1c) change from baseline after 16 weeks in overweight
      Type 2 Diabetes Mellitus participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 Diabetes Mellitus >3 months by history prior to entering the trial, based on
             disease diagnostic criteria from the American Diabetes Association (ADA 2007).

          -  Men or women 18 years of age or older. Women must have a negative pregnancy test and
             be willing to use birth control during study duration and one month post.

          -  Have glycosylated hemoglobin (HbA1c) of >7.0% to ≤10.5% as determined by central
             laboratory at screening.

          -  Have a body mass index (BMI) between 27 and 40 kilograms/meter squared (kg/m^2),
             inclusive.

          -  Have been on the same doses for 3 months of any approved combination of 2 oral
             antihyperglycemic medications in any combination of the following: sulfonylureas (e.g.
             Chlorpropamide or Diabinese, Glimepiride or Amaryl, Tolbutamide or Orinase, Tolazamide
             or Tolinase, Glipizide or Glucotrol, Glyburide also known as Micronase, Diabeta, or
             Glynase), biguanides (e.g. Glucophage or metformin), thiazolidinediones (e.g.
             Rosiglitazone or Avandia, or Pioglitazone or Actos), or dipeptidyl peptidase 4
             (DPP-IV) inhibitors (e.g. Sitagliptin or Januvia). A combination pill of any 2 of
             these drugs is allowed (1 only), (e.g. Metformin and Glipizide or Metaglip), (e.g.
             Metformin and Glyburide or Glucovance), (e.g. Pioglitazone and Glimepiride or
             Duetact), or (e.g. Sitagliptin and Metformin or Janumet).

        Exclusion Criteria:

          -  Have known Type 1 Diabetes Mellitus

          -  Have taken glucagon-like peptide-1 (GLP-1) or any GLP-1 analog drug (Byetta)

          -  Have a history of unstable angina, heart attack (myocardial infarction), heart
             arrhythmia (ventricular), congestive heart failure, or other coronary intervention
             (percutaneous transluminal coronary angioplasty [PTCA], open heart surgery, or
             coronary artery bypass graft [CABG]), a transient ischemic attack (TIA) or stroke
             (cerebrovascular accident) in the last 6 months prior to screening.

          -  Have acute or chronic hepatitis or elevated liver function tests (alanine
             transaminase), a history of chronic or recurrent pancreatitis. Have renal disease or a
             serum creatinine (blood test) >2 milligrams per deciliter (mg/dL). If taking
             biguanides (e.g. metformin or Glucophage), or DPP-IV inhibitors (e.g. Sitagliptin or
             Januvia or Janumet), creatinine must be ≤1.5 mg/dL.

          -  Currently taking prescription or over the counter medications to prevent weight loss.