Phase 3
Completed N=810
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-2)
Source: ClinicalTrials.gov NCT01075282 ↗Enrolled (actual)
810
Serious AEs
11.5%
Results posted
Jan 2015
Primary outcomePrimary: Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) — -1.08; -0.76; -0.63 percentage of glycosylated hemoglobin — p=<0.001
Summary
The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes. Participants must also be taking metformin and glimepiride.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) |
-1.08; -0.76; -0.63 | <0.001 sig |
| SECONDARY Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) |
-1.16; -0.89; -0.65; -0.90; -0.62; -0.59 | <0.001 sig |
| SECONDARY Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% at 26, 52 and 78 Weeks |
153; 122; 84; 140; 99; 80 | <0.001 sig |
| SECONDARY Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than or Equal to 6.5% at 26, 52 and 78 Weeks |
97; 74; 40; 71; 60; 35 | <0.001 sig |
| SECONDARY Change From Baseline to 26, 52 and 78 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles |
-1.79; -1.46; -1.58; -1.69; -1.32; -1.44 | 0.109 |
| SECONDARY Change From Baseline to 52 and 78 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S) |
29.95; 24.60; 28.54; 15.66; -2.89; -2.66 | — |
| SECONDARY Change From Baseline to 52 and 78 Weeks in Glucagon Concentration |
-3.91; -3.31; -3.85; -3.57; -3.37; -3.65 | — |
| SECONDARY Change From Baseline to 26, 52 and 78 Weeks for Body Weight |
-1.82; -1.47; 1.01; -1.87; -1.33; 1.44 | <0.001 sig |
| SECONDARY Change From Baseline to 26, 52 and 78 Weeks for Body Mass Index |
-0.64; -0.50; 0.44; -0.64; -0.39; 0.62 | — |
| SECONDARY Change From Baseline to 26, 52 and 78 Weeks in the EuroQol 5 Dimension |
0.01; 0.00; -0.01; 0.01; 0.00; -0.04 | — |
| SECONDARY Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Activities of Daily Living |
0.7; 0.1; -0.3; 0.9; 0.4; -0.6 | — |
| SECONDARY Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Self-Perception |
0.1; 0.2; -0.1; 0.5; 0.2; 0.1 | — |
| SECONDARY Change From Baseline to 26, 52 and 78 Weeks in the Low Blood Sugar Survey |
-2.8; -2.4; 0.3; -4.2; -4.1; -1.0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events at 26, 52 and 78 Weeks |
160; 146; 137; 189; 175; 175 | — |
| SECONDARY Number of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks |
1; 0; 1; 1; 0; 2 | — |
| SECONDARY Rate of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks |
0.01; 0.00; 0.01; 0.00; 0.00; 0.01 | — |
| SECONDARY Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26, 52 and 78 Weeks |
2; 4; 0; 11; 20; 8 | — |
| SECONDARY Change From Baseline to 26, 52 and 78 Weeks on Pancreatic Enzymes |
4.000; 4.000; 2.000; 4.000; 5.000; 3.000 | — |
| SECONDARY Number of Participants With Adjudicated Pancreatitis at 26, 52 and 78 Weeks |
1; 1; 0; 2; 1; 0 | — |
| SECONDARY Change From Baseline to 26, 52 and 78 Weeks on Serum Calcitonin |
0.163; 0.097; 0.149; 0.128; 0.132; 0.176 | — |
| SECONDARY Number of Participants With Adjudicated Cardiovascular Events at 26, 52 and 78 Weeks |
2; 1; 3; 0; 0; 0 | — |
| SECONDARY Change in Baseline to 26, 52 and 78 Weeks on Pulse Rate |
1.56; 0.74; -1.21; 1.29; 0.51; -0.52 | — |
| SECONDARY Change From Baseline to 26, 52, and 78 Weeks on Blood Pressure |
-1.28; -1.60; -0.03; 0.17; 0.09; 0.51 | — |
| SECONDARY Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Heart Rate |
2.64; 0.90; -1.24; 2.41; 0.38; -1.01 | — |
| SECONDARY Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval |
-1.71; -0.10; 1.24; 1.55; 1.34; 3.70 | — |
| SECONDARY Number of Participants With LY2189265 Antibodies at 26, 52, 78 Weeks and 4 Weeks After Last Dose of Study Drug (83 Weeks Maximum) |
11; 3; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 Diabetes not well controlled on 1, 2, or 3 oral antidiabetic medications (at least one of them must be metformin and/or a sulfonylurea)
- Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication
- HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications
- Accept treatment with metformin and glimepiride throughout the study, as per protocol
- Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for Insulin Glargine.
- Stable weight for 3 months prior to screening
- Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2)
- Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug
Exclusion Criteria
- Type 1 Diabetes
- HbA1c equal to or less than 6.5 at randomization
- Chronic insulin use
- Taking drugs to promote weight loss by prescription or over the counter
- Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled
- History of Heart Failure New York Heart Classification III or IV, or acute myocardial infarction, or stroke within 2 months of screening
- Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility
- Hepatitis or liver disease or ALT (alanine transaminase) greater than 3.0 of upper normal limit
- Acute or chronic pancreatitis of any form
- Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatinine clearance of less than 60 milliliters per minute (ml/min)
- History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer
- A serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/ml) at screening
- Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
- History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years
- Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing
- Organ transplant except cornea
- Have enrolled in another clinical trial within the last 30 days
- Have previously signed an informed consent or participated in a LY2189265 study
- Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening
Data sourced from ClinicalTrials.gov (NCT01075282). 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.