Phase 3
Completed N=978
A Study in Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01064687 ↗Enrolled (actual)
978
Serious AEs
7.0%
Results posted
Jan 2015
Primary outcomePrimary: Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) — -1.51; -1.30; -0.99; -0.46 percentage of glycosylated hemoglobin — p=<0.001
Summary
The purpose of this study is to determine if LY2189265 is effective and safe in reducing hemoglobin A1c (HbA1c), as compared to placebo (no medicine), or exenatide in participants with Type 2 Diabetes. The participants must also be taking metformin and pioglitazone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) |
-1.51; -1.30; -0.99; -0.46 | <0.001 sig |
| SECONDARY Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) |
-1.36; -1.07; -0.80 | <0.001 sig |
| SECONDARY Change From Baseline to 26 Weeks for Body Weight |
-1.34; 0.18; -1.14; 1.37 | <0.001 sig |
| SECONDARY Change From Baseline to 52 Weeks for Body Weight |
-1.08; 0.49; -0.76 | 0.507 |
| SECONDARY Change From Baseline to 26 Weeks on Body Mass Index (BMI) |
-0.48; 0.07; -0.41; 0.49 | <0.001 sig |
| SECONDARY Change From Baseline to 52 Weeks on Body Mass Index (BMI) |
-0.37; 0.18; -0.28 | 0.580 |
| SECONDARY Change From Baseline to 26 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles |
-46.82; -42.09; -37.48; -18.07 | <0.001 sig |
| SECONDARY Change From Baseline to 52 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles |
-43.84; -40.62; -36.16 | 0.004 sig |
| SECONDARY Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 26 Weeks |
78.2; 65.8; 52.3; 42.9; 62.7; 53.2 | <0.001 sig |
| SECONDARY Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 52 Weeks |
70.8; 59.1; 49.2; 57.2; 48.3; 34.6 | <0.001 sig |
| SECONDARY Change From Baseline to 26 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S) |
36.14; 23.61; 15.02; 0.93; -3.14; 1.16 | <0.001 sig |
| SECONDARY Change From Baseline to 52 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S) |
35.21; 25.69; 13.57; -7.48; -5.49; -3.75 | <0.001 sig |
| SECONDARY Change From Baseline to 26 Weeks in the EuroQol 5 |
4.50; 2.41; 3.94; 0.71; 0.01; 0.01 | — |
| SECONDARY Change From Baseline to 52 Weeks in the EuroQol 5 |
5.15; 3.52; 3.51; 0.02; 0.01; -0.00 | — |
| SECONDARY Change From Baseline to 26 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Version |
2.40; 2.56; 0.85; 0.49 | — |
| SECONDARY Change From Baseline to 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc) Versions |
2.05; 2.11; 0.69; 15.36; 15.46; 14.01 | — |
| SECONDARY Change From Baseline to 26 Weeks in the Impact of Weight on Activities of Daily Living |
0.18; 0.12; 0.47; 0.03 | — |
| SECONDARY Change From Baseline to 52 Weeks in the Impact of Weight on Activities of Daily Living |
0.18; -0.18; 0.35 | — |
| SECONDARY Change From Baseline to 26 Weeks on the Impact of Weight on Self-Perception |
0.56; 0.47; 0.46; 0.45 | — |
| SECONDARY Change From Baseline to 52 Weeks on the Impact of Weight on Self-Perception |
0.50; 0.47; 0.64 | — |
| SECONDARY Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks |
3; 2; 2; 1; 0; 0 | — |
| SECONDARY Change From Baseline to 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval |
-1.11; 0.91; 1.21; 1.32; 2.35; 0.93 | — |
| SECONDARY Change From Baseline to 52 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval |
1.28; 2.30; 2.52; 2.57; 0.69; -0.82 | — |
| SECONDARY Change in Baseline to 26 Weeks on Pulse Rate |
2.80; 2.80; 1.18; 0.61 | — |
| SECONDARY Change in Baseline to 52 Weeks on Pulse Rate |
1.68; 1.56; 1.15 | — |
| SECONDARY Change From Baseline to 26 Weeks on Blood Pressure |
0.11; -0.36; 0.06; 3.40; 0.76; 0.56 | — |
| SECONDARY Change From Baseline to 52 Weeks on Blood Pressure |
0.83; 1.62; 0.02; 0.89; 0.76; 0.02 | — |
| SECONDARY Number of Participants With Adjudicated Pancreatitis at 26 Weeks |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Adjudicated Pancreatitis at 52 Weeks |
1; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline to 26 Weeks on Pancreatic Enzymes |
12.50; 3.28; 5.56; -3.33; 14.81; 10.34 | — |
| SECONDARY Change From Baseline to 52 Weeks on Pancreatic Enzymes |
9.21; 2.78; 2.38; 16.67; 7.69; 7.85 | — |
| SECONDARY Change From Baseline to 26 Weeks on Serum Calcitonin |
0.20; 0.22; 0.05; 0.05 | — |
| SECONDARY Change From Baseline to 52 Weeks on Serum Calcitonin |
0.21; 0.05; 0.10 | — |
| SECONDARY Number of Self-reported Hypoglycemic Events at 26 Weeks |
0; 0; 1; 0; 31; 25 | — |
| SECONDARY Number of Self-reported Hypoglycemic Events at 52 Weeks |
0; 0; 2; 53; 39; 205 | — |
| SECONDARY Rate of Self-reported Hypoglycemic Events at 26 Weeks |
0.00; 0.00; 0.01; 0.00; 0.22; 0.18 | — |
| SECONDARY Rate of Self-reported Hypoglycemic Events at 52 Weeks |
0.00; 0.00; 0.01; 0.19; 0.14; 0.76 | — |
| SECONDARY Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 26 Weeks |
4; 14; 13; 22 | — |
| SECONDARY Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 52 Weeks |
10; 27; 31 | — |
| SECONDARY Number of Participants With LY2189265 Antibodies at 26 Weeks |
6; 12; 2 | — |
| SECONDARY Number of Participants With LY2189265 Antibodies at 52 Weeks and 4 Weeks After Last Dose of Study Drug |
3; 2; 2; 1; 0; 1 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events at 26 Weeks |
215; 199; 198; 104 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events at 52 Weeks |
226; 220; 221; 47; 41 | — |
| SECONDARY Change From Baseline to 26 Weeks in Hematological and Biochemical Lab Values |
NA; NA; NA; NA | — |
| SECONDARY Change From Baseline to 52 Weeks in Hematological and Biochemical Lab Values |
NA; NA; NA | — |
| SECONDARY Change From Baseline to 26 Weeks in N Terminal Pro Brain Natriuretic Peptide (NT-proBNP) |
-6.77; -2.96; -3.38; -0.85 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration Curve (AUC) for LY2189265 |
12383; 6627 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 Diabetes (T2D) not well controlled on 1, 2, or 3 oral antidiabetic medications
- 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
- Able to tolerate minimum dose of 1500 milligrams (mg) metformin a day and 30 mg pioglitazone per day.
- Willing to inject subcutaneous (SC) medication up to 2 times per day
- Stable weight for 3 months prior to screening
- Body mass index (BMI) between 23 and 45 kilograms per meter squared (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 before randomization or 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 fluid retention or edema
- History of Heart Failure New York Heart Classification II, III, or IV or acute myocardial infarction or stroke within 2 months of screening
- Gastrointestinal (GI; stomach) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility
- Hepatitis or liver disease or alanine transaminase (ALT) greater than 2.5 times the upper limit of normal
- 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 creatine 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 (pg/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 (dulaglutide) study
- Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening
Data sourced from ClinicalTrials.gov (NCT01064687). 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.