What AWARD-7 measured first
| Insulin Glarginen=175 | Dulaglutide 0.75 mgn=149 | Dulaglutide 1.5 mgn=138 |
|---|---|---|
| -1.13(0.12) | -1.12(0.12) | -1.19(0.13) |
A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-weekly Dulaglutide With Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes and Moderate or Severe Chronic Kidney Disease
Change From Baseline in Hemoglobin A1c (HbA1c) (percentage of HbA1c), Baseline, 26 Weeks. Insulin Glargine: -1.13; Dulaglutide 0.75 mg: -1.12; Dulaglutide 1.5 mg: -1.19.
As posted on ClinicalTrials.gov (NCT01621178), updated at source Sep 19, 2019. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Insulin Glarginen=175 | Dulaglutide 0.75 mgn=149 | Dulaglutide 1.5 mgn=138 |
|---|---|---|
| -1.13(0.12) | -1.12(0.12) | -1.19(0.13) |
Percent of participants affected, Up To Week 52. The most common events the registry lists.
| Event | Insulin Glargine | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg |
|---|---|---|---|
| Any serious event | 28.9% | 25.3% | 21.4% |
| Blood creatinine increased | 46.4% | 37.4% | 38.5% |
| Nausea | 4.6% | 14.2% | 19.8% |
| Diarrhoea | 7.2% | 15.8% | 16.1% |
| Vomiting | 4.6% | 8.4% | 13.5% |
| Glomerular filtration rate decreased | 13.4% | 10.5% | 8.9% |
| Upper respiratory tract infection | 10.3% | 6.8% | 4.2% |
| Hypertension | 10.3% | 6.8% | 7.3% |
| Urinary tract infection | 9.8% | 5.3% | 6.8% |
| Weight increased | 8.2% | 4.7% | 4.7% |
| Influenza | 5.2% | 7.9% | 6.3% |
| Oedema peripheral | 7.7% | 6.3% | 5.2% |
| Cough | 7.7% | 3.7% | 3.6% |
| Hyperkalaemia | 6.7% | 4.2% | 6.3% |
| Constipation | 3.1% | 5.3% | 6.3% |
| Nasopharyngitis | 6.2% | 4.7% | 5.7% |
| Dizziness | 5.2% | 5.8% | 4.2% |
| Sinusitis | 5.7% | 2.1% | 1% |
| Decreased appetite | 1.5% | 2.6% | 5.7% |
| Anaemia | 5.2% | 1.6% | 2.6% |
| Back pain | 3.6% | 4.2% | 5.2% |
| Insulin Glarginen=182 | Dulaglutide 0.75 mgn=164 | Dulaglutide 1.5 mgn=152 |
|---|---|---|
| 34.6 | 31.7 | 37.5 |
| Insulin Glarginen=182 | Dulaglutide 0.75 mgn=164 | Dulaglutide 1.5 mgn=152 |
|---|---|---|
| 75.3 | 72.6 | 78.3 |
| Insulin Glarginen=128 | Dulaglutide 0.75 mgn=107 | Dulaglutide 1.5 mgn=102 |
|---|---|---|
| -37.6(3.41) | -31.7(3.53) | -33.7(3.77) |
| Insulin Glarginen=162 | Dulaglutide 0.75 mgn=145 | Dulaglutide 1.5 mgn=132 |
|---|---|---|
| -19.1(6.00) | 17.7(6.14) | 23.1(6.50) |
| Insulin Glarginen=177 | Dulaglutide 0.75 mgn=154 | Dulaglutide 1.5 mgn=141 |
|---|---|---|
| 16.64(2.76) | 26.16(2.80) | 18.12(3.00) |
| Insulin Glarginen=134 | Dulaglutide 0.75 mgn=118 | Dulaglutide 1.5 mgn=110 |
|---|---|---|
| 64.9 | 52.5 | 56.4 |
| Insulin Glarginen=176 | Dulaglutide 0.75 mgn=169 | Dulaglutide 1.5 mgn=163 |
|---|---|---|
| 0.10(-0.04 to 0.28) | 0.02(-0.15 to 0.15) | 0.04(-0.14 to 0.20) |
| Insulin Glarginen=176 | Dulaglutide 0.75 mgn=169 | Dulaglutide 1.5 mgn=163 |
|---|---|---|
| -2.5(-6.0 to 1.0) | -1.0(-4.5 to 3.0) | -1.0(-5.5 to 3.0) |
| Insulin Glarginen=176 | Dulaglutide 0.75 mgn=169 | Dulaglutide 1.5 mgn=163 |
|---|---|---|
| -2.0(-4.0 to 0.5) | -1.0(-3.5 to 2.0) | -0.5(-4.0 to 2.0) |
| Insulin Glarginen=181 | Dulaglutide 0.75 mgn=175 | Dulaglutide 1.5 mgn=175 |
|---|---|---|
| -1.3(-71.7 to 62.0) | -11.1(-147.8 to 33.2) | -10.2(-180.5 to 53.1) |
| Insulin Glarginen=175 | Dulaglutide 0.75 mgn=151 | Dulaglutide 1.5 mgn=140 |
|---|---|---|
| 1.11(0.346) | -2.02(0.357) | -2.81(0.374) |
| Measure | Insulin Glarginen=194 | Dulaglutide 0.75 mgn=189 | Dulaglutide 1.5 mgn=190 |
|---|---|---|---|
| Total Hypo | 71.6 | 50.8 | 43.2 |
| Documented Symptomatic Hypo | 60.3 | 40.7 | 31.6 |
| Severe Hypo | 4.1 | 1.1 | 0 |
| Nocturnal Hypo | 38.1 | 15.9 | 13.2 |
The purpose of this study is to determine the glycemic efficacy and safety of dulaglutide compared to insulin glargine in the treatment of participants with type 2 diabetes and moderate or severe chronic kidney disease.
Inclusion Criteria: * Men and non-pregnant women aged ≥18 years * Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5% * Type 2 diabetes on insulin or insulin + oral antihyperglycemic medication * Participants with presumed diabetic kidney disease with or without hypertensive nephrosclerosis diagnosed with moderate or severe CKD with estimated glomerular filtration rate (eGFR) of ≥15 to \<60 milliliters per minute (mL/min)/1.73 meter squared (m\^2) * Able and willing to perform multiple daily injections * Body mass index (BMI) between 23 and 45 kilogram/square meter (kg/m\^2) Exclusion Criteria: * Stage 5 CKD as defined by eGFR \<15 mL/min/1.73 m\^2 OR having required dialysis * Rapidly progressing renal dysfunction likely to require renal replacement * History of a transplanted organ * Type 1 diabetes mellitus * At screening a systolic blood pressure of ≥150 mmHg or a diastolic blood pressure of ≥90 mmHg with or without antihypertensive medication * An episode of ketoacidosis or hyperosmolar state/coma in the past 6 months or a history of severe hypoglycemia in the past 3 months prior to the Screening Visit * Cardiovascular conditions within 12 weeks prior to randomization: acute myocardial infarction, New York Heart Association (NYHA) class III or class IV heart failure, or cerebrovascular accident (stroke) * Acute or chronic hepatitis * Signs and symptoms of chronic or acute pancreatitis, or were in the past diagnosed with pancreatitis * Serum calcitonin ≥35 picograms per milliliter (pg/mL) at Screening Visit * Self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma * Known history of untreated proliferative retinopathy
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.