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AWARD-7: Dulaglutide With Impaired Kidney Function

Last verified May 2026 · Phase 3 · Finished; published June 2018 · NCT01621178 ↗

By Ruth Calder · Enforcement Editor
Editorially reviewed (not clinically reviewed). Not medical advice · How we verify contentLast reviewed

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

EndpointTreatmentComparatorDifference
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 m²Insulin glargine: −3.3 mL/min/1.73 m²Smaller 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-yearInsulin glargine: 14.36 events/patient-yearDulaglutide 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/dLInsulin glargine: +0.12 mg/dLSmaller 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/minInsulin glargine: −2.5 mL/minSmaller decline on dulaglutide

Adverse events

EventTreatment rateComparator 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

On its primary endpoint — How far three-month average blood sugar fell by 26 weeks, against insulin adjusted to target — the treatment arm recorded Dulaglutide 1.5 mg: −1.19% (SE 0.13); dulaglutide 0.75 mg: −1.12% (SE 0.12) against Insulin glargine (titrated): −1.13% (SE 0.12) for the comparator. 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.
577 participants, over 52 weeks of blinded treatment, with the blood-sugar endpoint read at 26 weeks and the kidney, weight and hypoglycemia measures carried to 52. It was a Phase 3 trial, finished; published June 2018. Registered as NCT01621178, which you can look up yourself rather than taking anyone's summary for it.
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. ⚠ A trial result describes the population it was measured in. If you differ from it materially — in age, in baseline weight, in whether you have diabetes — the number is context rather than a prediction.
The most commonly reported were nausea (Dulaglutide 1.5 mg: 19.8% (38/192); dulaglutide 0.75 mg: 14.2% (27/190) against Insulin glargine: 4.6% (9/194) on comparator), diarrhea (Dulaglutide 1.5 mg: 16.1% (31/192); dulaglutide 0.75 mg: 15.8% (30/190) against Insulin glargine: 7.2% (14/194) on comparator), vomiting (Dulaglutide 1.5 mg: 13.5% (26/192); dulaglutide 0.75 mg: 8.4% (16/190) against Insulin glargine: 4.6% (9/194) on comparator). About 20% at the higher dose against under 5% on insulin — the usual trade for what this class offers. Rates come from this trial's population under its own dose-escalation schedule; a faster or slower titration changes what people experience.
Secondary endpoints included three-month average blood sugar at a full year (Dulaglutide 1.5 mg: −1.10% (SE 0.13); dulaglutide 0.75 mg: −1.10% (SE 0.12) against Insulin glargine: −1.00% (SE 0.12)); how much kidney filtration was lost over the year (Dulaglutide 1.5 mg: −2.0 mL/min/1.73 m²; dulaglutide 0.75 mg: −1.5 mL/min/1.73 m² against Insulin glargine: −3.3 mL/min/1.73 m²); protein leaking into the urine, at a year (Dulaglutide 1.5 mg: −11.5%; dulaglutide 0.75 mg: −3.0% against Insulin glargine: +3.5%). ⚠ Secondary endpoints are weaker evidence than the primary one — a trial is powered for its primary outcome, and the rest are read as supporting rather than as findings in their own right.
Dulaglutide (Trulicity) 1.5 mg and 0.75 mg is what the protocol used. This trial is not complete, so treat the figures as provisional. ⛔ Where a drug is investigational, anything sold under its name online is outside the prescribing system entirely, and this register does not list those sellers.
It cannot tell you that. A trial reports an average across a defined population under a fixed protocol, with monitoring and adherence support most people do not get. It is the best evidence available and it is still a distribution rather than a promise — some participants lost far more than the mean and some lost nothing. What it is genuinely good for is comparing options against each other, which is what the rest of this section is for.

References

  1. 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. 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. 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. 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.

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