Phase 3 · Dulaglutide

AWARD-10 trial results

A Randomized, Parallel-Arm, Double-Blind Study of Efficacy and Safety of Dulaglutide When Added to SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus

Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand) (percentage of HbA1c), Baseline, Week 24. 1.5 mg Dulaglutide: -1.34; 0.75 mg Dulaglutide: -1.21; Placebo: -0.54.

Participants
424
Status
completed
Completed
2017-02
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT02597049), updated at source Jun 17, 2020. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What AWARD-10 measured first

Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)percentage of HbA1c · Baseline, Week 24 · least squares mean
1.5 mg Dulaglutiden=1320.75 mg Dulaglutiden=134Placebon=133
-1.34(0.064)-1.21(0.064)-0.54(0.064)
Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)percentage of HbA1c · Baseline, Week 24 · least squares mean
1.5 mg Dulaglutiden=1300.75 mg Dulaglutiden=131Placebon=123
-1.33(0.063)-1.19(0.063)-0.51(0.065)
Side effects by arm

Side effects in AWARD-10

Percent of participants affected, Baseline to end of study (up to 24 weeks). The most common events the registry lists.

Event1.5 mg Dulaglutide0.75 mg DulaglutidePlacebo
Any serious event3.5%2.1%3.6%
Nausea14.8%5%3.6%
Diarrhoea5.6%9.9%2.9%
Headache5.6%3.5%9.3%
Back pain9.2%8.5%7.1%
Viral upper respiratory tract infection6.3%5.7%7.9%
Secondary outcomes

What else it measured

Percentage of Participants With HbA1c <7%percentage of participants · 24 Weeks · number
Measure1.5 mg Dulaglutiden=1420.75 mg Dulaglutiden=141Placebon=140
Treatment-regimen Estimand71.2160.4531.58
Efficacy Estimand71.5461.8332.52
Change From Baseline in Body Weight at 24 Weekskilograms (kg) · Baseline, Week 24 · least squares mean
Measure1.5 mg Dulaglutiden=1420.75 mg Dulaglutiden=141Placebon=140
Treatment-regimen Estimand-3.1(0.30)-2.6(0.30)-2.1(0.30)
Efficacy Estimand-3.1(0.30)-2.6(0.30)-2.3(0.31)
Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeksmilligram/deciliter (mg/dL) · Baseline, Week 24 · least squares mean
Measure1.5 mg Dulaglutiden=1420.75 mg Dulaglutiden=141Placebon=140
Treatment-regimen Estimand-31.6(2.17)-26.5(2.18)-6.9(2.21)
Efficacy Estimand-31.9(2.11)-26.0(2.12)-5.3(2.21)
Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeksmg/dL · Baseline, Week 24 · least squares mean
Measure1.5 mg Dulaglutiden=1420.75 mg Dulaglutiden=141Placebon=140
Pre-morning Morning Meal-27.8(2.13)-23.2(2.17)-8.1(2.14)
2-Hour Postprandial Morning Meal-44.6(3.31)-41.1(3.30)-20.1(3.33)
Pre-Mid Day Meal-26.0(2.91)-22.0(2.94)-7.7(2.93)
2-Hour Postprandial Mid Day Meal-31.8(3.47)-25.5(3.47)-12.8(3.53)
Pre-Evening Meal-30.3(2.85)-30.1(2.93)-7.5(2.91)
2-Hour Postprandial Evening Meal-36.0(3.30)-30.6(3.31)-13.9(3.38)
Change From Baseline in Fasting Glucagon at 24 Weekspicomole per liter (pmol/L) · Baseline, Week 24 · least squares mean
Measure1.5 mg Dulaglutiden=1420.75 mg Dulaglutiden=141Placebon=140
Treatment-regimen Estimand-2.1(0.39)-1.5(0.39)-0.9(0.40)
Efficacy Estimand-2.2(0.39)-1.4(0.39)-0.9(0.41)
Rate of Hypoglycemic Events Adjusted Per 30 DaysNumber of events/participant/30 days · Baseline through 24 Weeks · mean
Measure1.5 mg Dulaglutiden=1420.75 mg Dulaglutiden=141Placebon=140
Total Hypoglycemia0.026(0.1827)0.022(0.1375)0.017(0.1320)
Documented Symptomatic Hypoglycemia0.013(0.1406)0.013(0.1030)0.010(0.0893)
Asymptomatic Hypoglycemia0.013(0.1180)0.008(0.0639)0.006(0.0540)
Probable Symptomatic0.000(0.0000)0.001(0.0152)0.001(0.0147)
Relative Hypoglycemia0.003(0.0311)0.001(0.0150)0.005(0.0493)
Nocturnal Hypoglycemia0.002(0.0288)0.009(0.0821)0.000(0.0000)
Number of Participants Requiring Rescue Therapy Due to Severe Persistent HyperglycemiaParticipants · Baseline through 24 Weeks · count of participants
1.5 mg Dulaglutiden=1420.75 mg Dulaglutiden=141Placebon=140
032
Number of Participants With Adjudicated Acute Pancreatitis EventsParticipants · Baseline through 24 Weeks · count of participants
1.5 mg Dulaglutiden=1420.75 mg Dulaglutiden=141Placebon=140
000
Number of Participants With Adjudicated Cardiovascular (CV) EventsParticipants · Baseline through 24 Weeks · count of participants
Measure1.5 mg Dulaglutiden=1420.75 mg Dulaglutiden=141Placebon=140
Any CV Event003
Fatal CV Event000
Non-fatal CV Event003
The trial

How AWARD-10 was run

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as dulaglutide when added to sodium-glucose co-transporter 2 (SGLT2) inhibitors in participants with type 2 diabetes mellitus.

  • 1.5 mg Dulaglutide: 1.5 milligrams (mg) given subcutaneously (SC) once a week for 24 weeks.
  • 0.75 mg Dulaglutide: 0.75 mg dulaglutide given SC once a week for 24 weeks.
  • Placebo: Placebo given SC once a week for 24 weeks.
Who could join the trial

Inclusion Criteria: * Have type 2 diabetes mellitus (based on the World Health Organization's \[WHO\] diagnostic criteria) * Have been treated with an SGLT2 inhibitor, with or without metformin, for at least 3 months prior to study entry (minimum required doses for that period for allowed SGLT2 inhibitors: empagliflozin 10 mg, dapagliflozin 5 or 10 mg \[per country-specific label\], canagliflozin 100 mg); minimum required dose for metformin, if used, is ≥1500 mg/day and must be reached (or highest tolerated dose which is acceptable with documented gastrointestinal \[GI\] intolerability) * Daily doses of all allowed oral antihyperglycemia agent (OAMs) must have been stable for at least 12 weeks (±3 days) prior to randomization (study enrollment); daily doses of SGLT2 inhibitor and metformin, if used, will be considered stable during this period if: * all prescribed daily doses were in the range between the minimum required dose and maximum-approved dose per country-specific label; and * \>90% of prescribed daily doses were equal to the dose at randomization * Have HbA1c ≥7.0% and ≤9.5% at study entry and approximately 1 week prior to randomization * Have body mass index (BMI) ≤45 kilograms per meter squared (kg/m\^2) and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment Exclusion Criteria: * Have type 1 diabetes mellitus * Have been treated with any other OAMs (other than SGLT2 inhibitors and metformin), glucagon-like peptide-1 receptor agonist (GLP-1 RA), pramlintide or insulin 3 months prior to study entry, or between study entry and randomization; or initiate metformin between study entry and randomization; short-term use of insulin for acute care (≤14 days) during the 3-month period prior to entry is not exclusionary * Have any condition that is a contraindication for use of the GLP-1 RA class or the SGLT2 inhibitor class (per country-specific labels) at study entry or develop such condition between study entry and randomization * Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial * Had chronic or acute pancreatitis any time prior to study entry * Estimated glomerular filtration rate (eGFR) \<45 milliliters(mL)/minute/1.73m\^2, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead in * Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) in the absence of known C-cell hyperplasia (this exclusion includes participants with a family history of MEN 2A or 2B, whose family history for...

Published papers

Papers from AWARD-10

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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