Phase 2
Completed N=106
A Study of LY2189102 in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00942188 ↗Enrolled (actual)
106
Serious AEs
1.9%
Results posted
Mar 2018
Primary outcomePrimary: Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks — -0.457; -0.561; -0.428; -0.183 percentage of glycosylated hemoglobin
Summary
Study to evaluate the safety, tolerability and efficacy of LY2189102 in patients with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks |
-0.457; -0.561; -0.428; -0.183 | — |
| SECONDARY Change From Baseline in Fasting Glucose at 12 Weeks |
-0.873; -1.270; -0.629; -0.019 | — |
| SECONDARY Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks |
-1.589; -0.918; -0.229; 1.405 | — |
| SECONDARY 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 |
22; 17; 18; 24; 22; 17 | — |
| SECONDARY Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12 |
-0.456; -0.555; -0.413; -0.186; -0.459; -0.588 | — |
| SECONDARY Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks) |
269.39; 6094.67; 39994.74 | — |
| SECONDARY PK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks) |
45777.78; 986533.33; 6555789.47 | — |
| SECONDARY Pharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks) |
252.83; 5532.00; 35815.79 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Current use of anti-diabetic pharmacotherapy (except metformin, under conditions specified in Inclusion Criteria above).
- 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.
- Have a serious medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine, or neurological disease, or any clinically significant laboratory abnormality.
- Have had lymphoma, leukemia, or any non-breast malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease.
- Have h
Data sourced from ClinicalTrials.gov (NCT00942188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.