Phase 3
Completed N=424
A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02597049 ↗Enrolled (actual)
424
Serious AEs
3.1%
Results posted
Apr 2018
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand) — -1.34; -1.21; -0.54 percentage of HbA1c — p=<.001
◆ Published Evidence
Highly cited
259citations · ~32 / year
Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial.
Summary
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.
Linked Publications (2)
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Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial.
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Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand) |
-1.34; -1.21; -0.54 | <.001 sig |
| PRIMARY Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand) |
-1.33; -1.19; -0.51 | <.001 sig |
| SECONDARY Percentage of Participants With HbA1c <7% |
71.21; 60.45; 31.58; 71.54; 61.83; 32.52 | < .001 sig |
| SECONDARY Change From Baseline in Body Weight at 24 Weeks |
-3.1; -2.6; -2.1; -3.1; -2.6; -2.3 | 0.027 sig |
| SECONDARY Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks |
-31.6; -26.5; -6.9; -31.9; -26.0; -5.3 | < .001 sig |
| SECONDARY Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks |
-27.8; -23.2; -8.1; -44.6; -41.1; -20.1 | < .001 sig |
| SECONDARY Change From Baseline in Fasting Glucagon at 24 Weeks |
-2.1; -1.5; -0.9; -2.2; -1.4; -0.9 | 0.032 sig |
| SECONDARY Rate of Hypoglycemic Events Adjusted Per 30 Days |
0.026; 0.022; 0.017; 0.013; 0.013; 0.010 | — |
| SECONDARY Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia |
0; 3; 2 | — |
| SECONDARY Number of Participants With Adjudicated Acute Pancreatitis Events |
0; 0; 0 | — |
| SECONDARY Number of Participants With Adjudicated Cardiovascular (CV) Events |
0; 0; 3; 0; 0; 0 | — |
Eligibility Criteria
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 the syndrome is rearranged during transfect [RET]-negative; the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B have a known RET mutation and the potential participant for the study is negative for the RET mutation)
- Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)
- Have a serum calcitonin ≥20 picograms/mL as determined by the central laboratory at study entry
Data sourced from ClinicalTrials.gov (NCT02597049) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.