What AWARD-10 measured first
| 1.5 mg Dulaglutiden=132 | 0.75 mg Dulaglutiden=134 | Placebon=133 |
|---|---|---|
| -1.34(0.064) | -1.21(0.064) | -0.54(0.064) |
| 1.5 mg Dulaglutiden=130 | 0.75 mg Dulaglutiden=131 | Placebon=123 |
|---|---|---|
| -1.33(0.063) | -1.19(0.063) | -0.51(0.065) |
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.
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.
| 1.5 mg Dulaglutiden=132 | 0.75 mg Dulaglutiden=134 | Placebon=133 |
|---|---|---|
| -1.34(0.064) | -1.21(0.064) | -0.54(0.064) |
| 1.5 mg Dulaglutiden=130 | 0.75 mg Dulaglutiden=131 | Placebon=123 |
|---|---|---|
| -1.33(0.063) | -1.19(0.063) | -0.51(0.065) |
Percent of participants affected, Baseline to end of study (up to 24 weeks). The most common events the registry lists.
| Event | 1.5 mg Dulaglutide | 0.75 mg Dulaglutide | Placebo |
|---|---|---|---|
| Any serious event | 3.5% | 2.1% | 3.6% |
| Nausea | 14.8% | 5% | 3.6% |
| Diarrhoea | 5.6% | 9.9% | 2.9% |
| Headache | 5.6% | 3.5% | 9.3% |
| Back pain | 9.2% | 8.5% | 7.1% |
| Viral upper respiratory tract infection | 6.3% | 5.7% | 7.9% |
| Measure | 1.5 mg Dulaglutiden=142 | 0.75 mg Dulaglutiden=141 | Placebon=140 |
|---|---|---|---|
| Treatment-regimen Estimand | 71.21 | 60.45 | 31.58 |
| Efficacy Estimand | 71.54 | 61.83 | 32.52 |
| Measure | 1.5 mg Dulaglutiden=142 | 0.75 mg Dulaglutiden=141 | Placebon=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) |
| Measure | 1.5 mg Dulaglutiden=142 | 0.75 mg Dulaglutiden=141 | Placebon=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) |
| Measure | 1.5 mg Dulaglutiden=142 | 0.75 mg Dulaglutiden=141 | Placebon=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) |
| Measure | 1.5 mg Dulaglutiden=142 | 0.75 mg Dulaglutiden=141 | Placebon=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) |
| Measure | 1.5 mg Dulaglutiden=142 | 0.75 mg Dulaglutiden=141 | Placebon=140 |
|---|---|---|---|
| Total Hypoglycemia | 0.026(0.1827) | 0.022(0.1375) | 0.017(0.1320) |
| Documented Symptomatic Hypoglycemia | 0.013(0.1406) | 0.013(0.1030) | 0.010(0.0893) |
| Asymptomatic Hypoglycemia | 0.013(0.1180) | 0.008(0.0639) | 0.006(0.0540) |
| Probable Symptomatic | 0.000(0.0000) | 0.001(0.0152) | 0.001(0.0147) |
| Relative Hypoglycemia | 0.003(0.0311) | 0.001(0.0150) | 0.005(0.0493) |
| Nocturnal Hypoglycemia | 0.002(0.0288) | 0.009(0.0821) | 0.000(0.0000) |
| 1.5 mg Dulaglutiden=142 | 0.75 mg Dulaglutiden=141 | Placebon=140 |
|---|---|---|
| 0 | 3 | 2 |
| 1.5 mg Dulaglutiden=142 | 0.75 mg Dulaglutiden=141 | Placebon=140 |
|---|---|---|
| 0 | 0 | 0 |
| Measure | 1.5 mg Dulaglutiden=142 | 0.75 mg Dulaglutiden=141 | Placebon=140 |
|---|---|---|---|
| Any CV Event | 0 | 0 | 3 |
| Fatal CV Event | 0 | 0 | 0 |
| Non-fatal CV Event | 0 | 0 | 3 |
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.
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...
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.