Phase 3
Completed N=807
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3)
Source: ClinicalTrials.gov NCT01126580 ↗Enrolled (actual)
807
Serious AEs
6.3%
Results posted
Jan 2015
Primary outcomePrimary: Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) — -0.78; -0.71; -0.56 percentage of glycosylated hemoglobin — p=<0.001
Summary
The purpose of this study is to determine if LY2189265 is safe and effective in reducing glycosylated hemoglobin (HbA1c) as compared to metformin in participants with Type 2 Diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) |
-0.78; -0.71; -0.56 | <0.001 sig |
| SECONDARY Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c) |
-0.70; -0.55; -0.51 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of Less Than 7% and Less Than or Equal to 6.5% at 26 and 52 Weeks |
61.5; 62.6; 53.6; 46.0; 40.0; 29.8 | 0.023 sig |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Fasting Blood Glucose |
-1.61; -1.46; -1.34; -1.56; -1.00; -1.15 | 0.079 |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles |
-1.98; -1.75; -1.68; -1.99; -1.71; -1.58 | 0.061 |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Body Weight |
-2.29; -1.36; -2.22; -1.93; -1.09; -2.20 | 0.811 |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Body Mass Index (BMI) |
-0.86; -0.51; -0.82; -0.73; -0.42; -0.83 | 0.750 |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Homeostasis Model Assessment of Beta-cell Function |
36.55; 28.96; 14.11; 29.97; 22.5; 9.77 | <0.001 sig |
| SECONDARY Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) Score |
0.09; 0.19; 0.02; 0.39; -0.05; 0.28 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) Score |
0.72; 0.63; 0.79; 0.45; 0.61; 0.75 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Status Version |
1.93; 1.81; 2.04; 1.82; 1.29; 1.94 | — |
| SECONDARY Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Change Version |
12.92; 12.73; 12.58 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in the Diabetes Symptoms Checklist Participant-reported Outcome (DSC-r) Score |
0.24; -0.16; 0.41; 0.49; 0.42; 0.59 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events at 26 and 52 Weeks |
163; 150; 151; 179; 177; 170 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval |
2.60; 1.38; -0.91; 3.76; 0.73; -0.53 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate |
1.60; 2.57; 0.82; 2.02; 2.36; 1.27 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Pulse Rate |
2.39; 2.14; 1.59; 1.84; 1.63; 1.12 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Blood Pressure |
-1.89; -2.61; -0.91; -0.11; -2.74; -0.98 | — |
| SECONDARY Percent Change From Baseline to 26 and 52 Weeks in Total Cholesterol |
-3.86; -1.77; -3.51; -1.69; -0.78; -3.88 | — |
| SECONDARY Percentage Change From Baseline to 26 and 52 Weeks in High Density Lipoprotein Cholesterol (HDL-C) |
2.39; 4.20; 5.78; 4.95; 2.31; 4.32 | — |
| SECONDARY Percentage Change From Baseline to 26 and 52 Weeks in Low Density Lipoprotein Cholesterol (LDL-C) |
-6.86; -2.70; -8.97; -2.06; -2.34; -7.23 | — |
| SECONDARY Percentage Change From Baseline to 26 and 52 Weeks in Triglycerides |
-2.35; -1.96; 2.56; -4.27; -0.86; 1.91 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes |
7.00; 6.00; 4.00; 5.50; 5.00; 4.00 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Serum Calcitonin |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Number of Participants With Treatment Emergent Anti-LY2189265 Antibodies |
10 | — |
| SECONDARY Number of Self-reported Hypoglycemic Events at 26 and 52 Weeks |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Rate of Self-reported Hypoglycemic Events at 52 Weeks |
0.00; 0.00; 0.00; 0.62; 0.15; 0.09 | — |
| SECONDARY Number of Participants With Adjudicated Pancreatitis at 52 Weeks Plus 30-day Follow up |
0; 0; 0 | — |
| SECONDARY Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks Plus 30-day Follow up |
1; 2; 1; 0; 0; 0 | — |
| SECONDARY Measurement of LY2189265 Drug Concentration for Pharmacokinetics: Area Under the Concentration Curve (AUC) |
12036; 5919 | — |
Eligibility Criteria
Inclusion Criteria
- Have type 2 diabetes for greater than or equal to 3 months and less than or equal to 5 years based on the disease diagnostic criteria (refer to the World Health Organization's [WHO] Classification of Diabetes).
- Are treatment-naïve, not optimally controlled with diet and exercise alone, or are taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding thiazolidinediones). For those on 1 OAM, the dose must be less than or equal to 50% the maximum authorized per local label.
- Are able and willing to tolerate a minimum dose of 1500 milligrams per day (mg/day) or up to 2000 mg/day of metformin.
- Have glycosylated hemoglobin (HbA1c) greater than or equal to 6.5% to less than or equal to 9.5%.
- Females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must: a) test negative for pregnancy at screening based on a serum pregnancy test, and b) agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or c) not be breastfeeding.
- Have a stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening.
- Have a body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2), inclusive.
- Are well-motivated, capable, and willing to: a) perform self-monitored blood glucose (SMBG) testing; b) learn how to self-inject treatment (LY2189265 or placebo) and c) maintain a study diary.
Exclusion Criteria
- Have type 1 diabetes mellitus.
- Are being or have been treated with any of the following medications: a) chronically treated with insulin for the treatment of diabetes in the past; however, a short-term use of insulin more than 3 months prior to screening is allowable, b) glucagon-like peptide 1 (GLP-1) analogs within 3 months prior to this screening, c) drugs to cause weight loss within 3 months prior to screening, d) thiazolidinediones (TZDs) within 3 months prior to screening, e) chronically treated (greater than or equal to 14 days) with an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening, or f) illegal drugs.
- Have had 1 or more cases of uncontrolled diabetes that required hospitalization in the 6 months prior to screening.
- Have stomach problems, have chronically taken medication to increase movement in the digestive tract or slow down the emptying of the digestive tract, or have had gastric bypass (bariatric) surgery.
- Have had problems with the heart or brain in the past 2 months prior to screening, such as a heart attack, chest pain, heart failure, heart bypass operation, angioplasty or stent insertion, a heart rhythm problem, or a stroke.
- Have a serum creatinine result which shows a greater than or equal to 1.5 milligrams per deciliter (mg/dL) for men or greater than or equal to 1.4 mg/dL for women.
- Have a problem with the liver or pancreas.
- Have a creatinine clearance result which shows less than 60 milliliters per minute (mL/min), evidence of a significant active, uncontrolled endocrine (hormone), or active autoimmune abnormality.
- Have a serum calcitonin test which shows greater than or equal to 20 picograms per milliliter (pcg/mL) at the time of screening.
- Have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B.
- Have cancer (except for skin cancer) or have been in remission from cancer for less than 5 years.
- Have had an organ transplant except for corneal transplant.
- Have received treatment within the last 30 days with a drug which has not been regulatory approved.
- Have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed within 30 days prior to screening.
- Have any condition that is a contraindication to or would interfere with medications provided for this study to treat diabetes.
- Have a blood disorder that would interfere with the drawing of blood glucose measurements or lab sampl
Data sourced from ClinicalTrials.gov (NCT01126580). 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.