AWARD-7: Dulaglutide With Impaired Kidney Function
Last verified May 2026 · Phase 3 · Finished; published June 2018 · NCT01621178 ↗
Kidney impairment complicates diabetes treatment because many drugs clear renally and insulin dosing becomes harder to judge. Excluding these patients from trials is standard and leaves prescribers guessing. AWARD-7's contribution is that it enrolled them deliberately and compared against the treatment they would otherwise get. The glycemic result is essentially a tie; the differences are in weight and hypoglycemia, which is where a GLP-1 would be expected to win against insulin.
- Enrollment
- 577
- Duration
- 52 weeks of blinded treatment, with the blood-sugar endpoint read at 26 weeks and the kidney, weight and hypoglycemia measures carried to 52
- Drug
- Dulaglutide (Trulicity) 1.5 mg and 0.75 mg
- Population
- Adults 18 and over with type 2 diabetes already on insulin — with or without oral drugs — an HbA1c between 7.5% and 10.5%, a BMI between 23 and 45, and diabetic kidney disease at moderate-to-severe stage, meaning filtration between 15 and 60. ⚠ Dialysis and end-stage disease were excluded, as were rapidly worsening kidney function, transplants, recent cardiac events and untreated proliferative eye disease. ★ Average filtration was around 38 and average HbA1c 8.6% — a genuinely advanced population that mainstream trials in this class simply do not enroll.
Primary endpoint
How far three-month average blood sugar fell by 26 weeks, against insulin adjusted to target
Treatment arm
Dulaglutide 1.5 mg: −1.19% (SE 0.13); dulaglutide 0.75 mg: −1.12% (SE 0.12)
Comparator
Insulin glargine (titrated): −1.13% (SE 0.12)
Treatment difference: Mean difference vs glargine: dulaglutide 1.5 mg −0.05 percentage points (non-inferiority P<0.001); dulaglutide 0.75 mg +0.02 percentage points (non-inferiority P<0.001)
★ A tie, and a tie is the point. In kidney disease at this stage most oral diabetes drugs are off the table and insulin has been the default by exclusion rather than by evidence. Matching titrated insulin on blood sugar is what earns the comparison; everything that separates the two is in the rows below.
Secondary endpoints
| Endpoint | Treatment | Comparator | Difference |
|---|---|---|---|
| Three-month average blood sugar at a full year ★ Note the asymmetry that makes this more impressive than a tie: the dulaglutide dose was fixed while the insulin was actively pushed upward toward target all year. A fixed weekly injection kept pace with a daily one being chased. | Dulaglutide 1.5 mg: −1.10% (SE 0.13); dulaglutide 0.75 mg: −1.10% (SE 0.12) | Insulin glargine: −1.00% (SE 0.12) | Glycemic non-inferiority sustained through one year |
| How much kidney filtration was lost over the year ★ The finding that made this trial matter beyond diabetes clinics: kidney function declined less on the drug than on insulin, despite identical blood sugar. If glucose control were the whole story the two arms would match. Later analysis tied part of the difference to the weight loss. | Dulaglutide 1.5 mg: −2.0 mL/min/1.73 m²; dulaglutide 0.75 mg: −1.5 mL/min/1.73 m² | Insulin glargine: −3.3 mL/min/1.73 m² | Smaller decline on both dulaglutide doses; difference vs glargine approximately +1.3 to +1.8 mL/min/1.73 m² at one year |
| Protein leaking into the urine, at a year ⚠ Down about 11.5% on the drug and UP 3.5% on insulin. Protein in the urine is the earliest and most movable kidney marker — real, and the softest of the measures here. | Dulaglutide 1.5 mg: −11.5%; dulaglutide 0.75 mg: −3.0% | Insulin glargine: +3.5% | Dulaglutide 1.5 mg lowered UACR while glargine raised it; the largest between-arm separation in any kidney biomarker reported |
| Weight change ★ The direction is what counts: about 2.7 kg off on the drug against 1.6 kg gained on insulin — a four-kilogram swing. In advanced kidney disease the scale is muddied by fluid shifts and muscle loss, which makes this harder to achieve than the number suggests. | Dulaglutide 1.5 mg: −2.66 kg (SE 0.467); dulaglutide 0.75 mg: −1.71 kg (SE 0.448) | Insulin glargine: +1.57 kg (SE 0.429) | Between-arm difference approximately −4.2 kg on dulaglutide 1.5 mg vs glargine; weight moved in opposite directions |
| How often blood sugar dropped too low, across the year ⛔ The single strongest reason to read this trial: roughly 60% fewer episodes. Failing kidneys clear insulin slowly, so a dose that was right yesterday can be too much today — which is why basal insulin is dangerous here in a way it is not in someone with healthy kidneys. | Dulaglutide 1.5 mg: 5.82 events/patient-year; dulaglutide 0.75 mg: 7.59 events/patient-year | Insulin glargine: 14.36 events/patient-year | Dulaglutide 1.5 mg cut total hypoglycemia rate by approximately 60% versus glargine |
| Episodes severe enough to need another person's help ★ Zero on the 1.5 mg dose against 6.7% on insulin. This is the event that produces ambulance calls, falls and fractures in this population, and it is where the practical case gets made. | Dulaglutide 1.5 mg: 0%; dulaglutide 0.75 mg: 2.6% | Insulin glargine: 6.7% | Zero severe hypoglycemia events on the dulaglutide 1.5 mg arm versus 6.7% on glargine |
| How many reached the standard blood-sugar target About a third either way. ★ Read it as parity rather than victory — a once-weekly injection got as many people to target as daily insulin being adjusted throughout. | Dulaglutide 1.5 mg: 32.9%; dulaglutide 0.75 mg: 33.5% | Insulin glargine: 29.1% | Numerically higher on dulaglutide; differences modest |
| Creatinine, the waste product kidney function is calculated from Rose less on the drug, which is arithmetically what produces the gentler filtration decline above — the two measures cross-check each other. | Dulaglutide 1.5 mg: +0.07 mg/dL; dulaglutide 0.75 mg: +0.04 mg/dL | Insulin glargine: +0.12 mg/dL | Smaller rise in creatinine on both dulaglutide doses |
| Kidney function estimated by a second, independent formula ★ A quietly important row. Kidney function is not measured directly but calculated, and different formulas can disagree. Here they agree, and that agreement is what makes the kidney result difficult to write off as a quirk of one equation. | Dulaglutide 1.5 mg: −1.5 mL/min; dulaglutide 0.75 mg: −1.3 mL/min | Insulin glargine: −2.5 mL/min | Smaller decline on dulaglutide |
Adverse events
| Event | Treatment rate | Comparator rate |
|---|---|---|
| Nausea About 20% at the higher dose against under 5% on insulin — the usual trade for what this class offers. | Dulaglutide 1.5 mg: 19.8% (38/192); dulaglutide 0.75 mg: 14.2% (27/190) | Insulin glargine: 4.6% (9/194) |
| Diarrhea Roughly twice the insulin rate at either dose. | Dulaglutide 1.5 mg: 16.1% (31/192); dulaglutide 0.75 mg: 15.8% (30/190) | Insulin glargine: 7.2% (14/194) |
| Vomiting ⚠ 13.5% at the higher dose against 4.6%. Worth taking seriously in advanced kidney disease, where fluid losses are less easily tolerated than in healthy people. | Dulaglutide 1.5 mg: 13.5% (26/192); dulaglutide 0.75 mg: 8.4% (16/190) | Insulin glargine: 4.6% (9/194) |
| Constipation Roughly twice the insulin rate, uncommon overall. | Dulaglutide 1.5 mg: 6.3% (12/192); dulaglutide 0.75 mg: 5.3% (10/190) | Insulin glargine: 3.1% (6/194) |
| Loss of appetite ⚠ Recorded as a side effect, and here that framing may be right rather than pedantic: appetite loss and muscle wasting are already problems in advanced kidney disease, so this is not purely the mechanism working. | Dulaglutide 1.5 mg: 5.7% (11/192); dulaglutide 0.75 mg: 2.6% (5/190) | Insulin glargine: 1.5% (3/194) |
| A lab-flagged rise in creatinine ★ Less common on the drug than on insulin — 38% against 46%. These are investigator-flagged lab results rather than the trial's kidney endpoint, and they point the same way as it does. | Dulaglutide 1.5 mg: 38.5% (74/192); dulaglutide 0.75 mg: 37.4% (71/190) | Insulin glargine: 46.4% (90/194) |
| A lab-flagged drop in kidney filtration Numerically lower on the drug, again agreeing with the formal kidney result. | Dulaglutide 1.5 mg: 8.9% (17/192); dulaglutide 0.75 mg: 10.5% (20/190) | Insulin glargine: 13.4% (26/194) |
| High potassium No excess on the drug — a genuine question in advanced kidney disease, where high potassium is a dangerous and common complication. | Dulaglutide 1.5 mg: 6.3% (12/192); dulaglutide 0.75 mg: 4.2% (8/190) | Insulin glargine: 6.7% (13/194) |
| Urinary tract infection Lower on the drug than on insulin. | Dulaglutide 1.5 mg: 6.8% (13/192); dulaglutide 0.75 mg: 5.3% (10/190) | Insulin glargine: 9.8% (19/194) |
| Anemia Lower on the drug — 2.6% against 5.2%. Anemia in kidney disease tracks how far the kidneys have declined, so this is consistent with the slower decline seen elsewhere in the table. | Dulaglutide 1.5 mg: 2.6% (5/192); dulaglutide 0.75 mg: 1.6% (3/190) | Insulin glargine: 5.2% (10/194) |
| Serious adverse events of any kind ★ Lower on the drug than on insulin, with no organ system standing out. | Dulaglutide 1.5 mg: 21.4% (41/192); dulaglutide 0.75 mg: 25.3% (48/190) | Insulin glargine: 28.9% (56/194) |
Clinical significance
This trial matters to prescribers managing diabetes with CKD, and is largely context for a weight-management reader. ⚠ It is not a kidney-outcomes trial — it did not test whether dulaglutide slows kidney disease, which is the question FLOW asked of semaglutide. Non-inferior glycemic control in a difficult population is a useful finding and a much narrower one than a renal-protection claim.
Frequently Asked Questions
References
- 1.Tuttle KR, Lakshmanan MC, Rayner B, Busch RS, Zimmermann AG, Woodward DB, Botros FT. Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial. Lancet Diabetes Endocrinol. 2018. PMID: 29910024.
- 2.U.S. National Library of Medicine. AWARD-7: A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD) — Study Results. ClinicalTrials.gov, NCT01621178. 2017. https://clinicaltrials.gov/study/NCT01621178
- 3.Tuttle KR, Rayner B, Lakshmanan MC, Kwan AYM, Konig M, Shurzinske L, Botros FT. Body weight and eGFR during dulaglutide treatment in type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7). Diabetes Obes Metab. 2019. PMID: 30762290.
- 4.Tuttle KR, Rayner B, Lakshmanan MC, Kwan AYM, Konig M, Shurzinske L, Botros FT. Clinical Outcomes by Albuminuria Status with Dulaglutide versus Insulin Glargine in Participants with Diabetes and CKD: AWARD-7 Exploratory Analysis. Kidney360. 2021. PMID: 35373017.