Conditions

Type 2 Diabetes

Keywords

DiabetesType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks
Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline HbA1c as a continuous covariate.
Baseline, 12 weeks

Secondary Outcomes (7)

Change From Baseline in Fasting Glucose at 12 Weeks
Baseline, 12 weeks
Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks
Baseline, 12 weeks
Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks
Baseline, 12 weeks
Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12
Baseline, week 10, week 12
Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks)
Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose
+2 more secondary outcomes

Study Arms (4)

0.6 milligrams (mg) LY2189102

EXPERIMENTAL

Drug: LY2189102

18 mg LY2189102

EXPERIMENTAL

Drug: LY2189102

180 mg LY2189102

EXPERIMENTAL

Drug: LY2189102

Placebo

PLACEBO COMPARATOR

0.9% Sodium Chloride

Drug: Placebo

Interventions

LY2189102DRUG

Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.

0.6 milligrams (mg) LY218910218 mg LY2189102180 mg LY2189102

PlaceboDRUG

Participants received 2 SC injections weekly for 12 weeks.

Placebo

Eligibility Criteria

Age20 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Have Type 2 Diabetes and confirmed by fasting C-peptide levels greater than or equal to 0.8 nanograms per milliliter \[ng/ml\]), with duration of more than 3 months.
Body mass index between 25 and 40 kilograms per square meter (kg/m2).
Stable on diet and exercise alone, with or without metformin monotherapy (stable regimen or dose for at least 8 weeks).
Drug-naïve or previous anti-diabetic pharmacotherapy use is allowed (for the latter, patient must have stopped taking pharmacotherapy greater than 12 weeks prior to screening and only if deemed appropriate by the investigator).
Angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, thiazide diuretics or calcium channel blockers are permitted for the treatment of hypertension or proteinuria.
Glycated hemoglobin level between 7% and 10%.
Baseline High-sensitivity C-reactive protein greater than or equal to 2 milligrams per liter (mg/L)
Females of childbearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must test negative for pregnancy at the time of enrollment based on a pregnancy test. Furthermore, sexually active female and male participants must agree to use 2 reliable methods of birth control during the study and for 3 months following the last dose of study drug.
Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.

You may not qualify if:

Current treatment with anti-inflammatory drugs, including corticosteroids and non-steroidal anti-inflammatory drugs (100 mg per day or less of aspirin allowed).
Within 60 days of the initial dose of the study drug, have received treatment with a drug that has not received regulatory approval for any indication.
Presence of autoantibodies to glutamic acid decarboxylase 65 or islet-cell autoantibody-2.
Evidence of tuberculosis as documented by a specific assay, medical history, and chest x-ray. A specific assay, (for example, tuberculin testing) will be conducted unless it is medically inappropriate. Exceptions include patients with a history of a positive specific assay for TB who have been treated with isonicotinyl hydrazine (documented) for at least 6 months, or patients with a previous diagnosis of TB who have been appropriately treated and can provide documentation.
Symptomatic herpes zoster within 3 months of randomization.
Show evidence of hepatitis C and/or positive hepatitis B surface antigen.
Show evidence of human immunodeficiency virus and/or positive test of antibodies to human immunodeficiency virus (HIV).
Received live or attenuated vaccine(s) within the previous 3 months prior to randomization or will receive within 3 months from the end of study.
Screening serum creatinine greater than 2.0 milligrams per deciliter (mg/dL).
Serum aspartate aminotransferase or alanine aminotransaminase concentration greater than 2x the upper limit of normal.
Known allergies to LY2189102 or excipients.
Previously completed or withdrawn from this study or any other study investigating LY2189102.
Have donated blood of greater than 500 mL within the preceding 30 days and intend to donate within 3 months from the end of study.
Have had other recent or ongoing signs of infection (for example, fever, current treatment with antibiotics).
Experienced a serious bacterial infection within 6 months of randomization.
+3 more criteria

Contact the study team to confirm eligibility.