Phase 3
Completed N=884
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)
Source: ClinicalTrials.gov NCT01191268 ↗Enrolled (actual)
884
Serious AEs
14.2%
Results posted
Oct 2014
Primary outcomePrimary: Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) — -1.64; -1.59; -1.41 percentage of glycosylated hemoglobin — p=<0.001
Summary
The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) |
-1.64; -1.59; -1.41 | <0.001 sig |
| SECONDARY Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c) |
-1.48; -1.42; -1.23 | <0.001 sig |
| SECONDARY Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52 |
67.6; 69.0; 56.8; 58.5; 56.3; 49.3 | 0.014 sig |
| SECONDARY Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia |
53.8; 54.5; 28.2; 44.0; 44.0; 26.8 | <0.001 sig |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles |
-0.36; -0.06; -2.01; -3.70; -3.29; -4.03 | 0.628 |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose |
-0.27; 0.22; -1.58; 0.08; 0.41; -1.01 | <0.001 sig |
| SECONDARY Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine) |
55.20; 59.11; 53.93; 93.24; 96.69; 132.00 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Body Weight |
-0.87; 0.18; 2.33; -0.35; 0.86; 2.89 | <0.001 sig |
| SECONDARY Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose |
91.00; 91.69; 90.75; 91.58; 93.21; 94.14 | — |
| SECONDARY Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI) |
-0.20; 0.21; 1.01; 0.09; 0.57; 1.33 | <0.001 sig |
| SECONDARY Change From Baseline to 26 and 52 Weeks in the EQ-5D |
-0.03; -0.03; -0.03; -0.04; -0.04; -0.03 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) |
-0.50; -0.60; -0.93; -0.50; -1.05; -1.28 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) |
0.60; 0.34; 0.18; 0.86; 0.22; 0.06 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS) |
3.75; 2.91; 2.83; 2.51; 0.92; 2.38 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes |
5.00; 4.00; 1.00; 2.00; 2.00; 0.00 | — |
| SECONDARY Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose |
61.21; 58.59; 61.18; 66.08; 60.97; 61.93 | — |
| 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 Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose |
0.75; 0.73; 0.78; 0.79; 0.78; 0.80 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Blood Pressure |
-0.97; -0.65; 2.23; -0.26; 1.04; 1.98 | — |
| SECONDARY Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose |
133.26; 134.03; 133.26; 132.67; 134.31; 134.90 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Pulse Rate |
2.84; 2.79; 0.90; 2.38; 2.27; 0.93 | — |
| SECONDARY Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose |
75.26; 75.08; 74.54; 78.30; 77.83; 76.02 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval |
0.29; 0.30; 1.59; 1.89; 1.48; 1.80 | — |
| SECONDARY Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate |
3.95; 4.18; 1.37; 3.02; 3.83; 1.03 | — |
| SECONDARY Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose |
NA; NA; NA; 0; 0; 0 | — |
| SECONDARY Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose |
4; 5; 9; 8; 7; 14 | — |
| SECONDARY Rate of Self-reported Hypoglycemic Events up to 52 Weeks |
0.03; 0.05; 0.08; 30.98; 35.03; 39.90 | — |
| SECONDARY Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks |
5; 6; 12; 0; 0; 2 | — |
| SECONDARY Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose |
NA; NA; 9 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose |
203; 216; 178; 217; 230; 206 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- Currently using insulin for at least 3 months with a conventional insulin regimen with or without oral medications
- Glycosylated hemoglobin (HbA1c) greater than or equal to 7% and less than or equal to 11%
- Willing to inject subcutaneous medication
- Willing to monitor blood glucose levels and adjust insulin dose
- Willing to maintain a study diary
- Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2)
- Stable weight for 3 months prior to screening
- Females of child bearing potential must test negative for pregnancy at screening 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
- Previous therapy with glucagon-like peptide 1 (GLP-1) agonists within 3 months prior to screening
- 1 or more episodes of ketoacidosis within 6 months prior to screening
- Have been treated with prescription or over the counter medication to promote weight loss within 3 months prior to screening
- Estimated glomerular filtration rate (eGFR) less than or equal to 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2) at screening
- Taking steroids for greater than 14 days except for topical, eye, nasal, or inhaled
- History of heart failure, New York Heart Classification III or IV within 2 months prior to screening
- Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking medications that directly affect GI motility
- Acute or chronic hepatitis or pancreatitis
- Self or family history of 2A or type 2B multiple endocrine neoplasia or medullary C-Cell hyperplasia
- Serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/mL) at screening
- Organ transplant except cornea
- Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
- History of or active malignancy except skin or in situ cervical or prostate cancer within the last 5 years
- Known drug or alcohol abuse
- Have enrolled in another clinical trial within the last 30 days
- Have previously signed an informed consent or participated in a LY2189265 study
Data sourced from ClinicalTrials.gov (NCT01191268). 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.