A Study of Dose Titration of LY2189265 in Overweight Participants With Type 2 Diabetes Mellitus (EGO)

Lilly

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: LY2189265; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00630825

12068

H9X-MC-GBCJ (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 262 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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262 participants in 4 patient groups, including a placebo group

1.0/2.0 milligram (mg) LY2189265

Experimental group

Description:

LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks

Treatment:

Drug: LY2189265

1.0/1.0 milligram (mg) LY2189265

Experimental group

Description:

LY2189265: 1.0 mg, subcutaneous (SC) injection, once weekly (QW) for 16 weeks

Treatment:

Drug: LY2189265

0.5/1.0 milligram (mg) LY2189265

Experimental group

Description:

LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks

Treatment:

Drug: LY2189265

Placebo

Placebo Comparator group

Description:

Placebo: subcutaneous (SC) injection, once weekly (QW) for 16 weeks

Treatment:

Drug: Placebo