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Phase 3 Completed N=300 Randomized Double-blind Treatment

A Study of Dulaglutide (LY2189265) in Participants With Type II Diabetes

Source: ClinicalTrials.gov NCT02152371 ↗
Enrolled (actual)
300
Serious AEs
5.3%
Results posted
Dec 2016
Primary outcomePrimary: Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c) — -1.44; -0.67 percentage of change — p=<.001
◆ Published Evidence
Established
20citations · ~3 / year
Dulaglutide 1.5 mg as an add-on option for patients uncontrolled on insulin: Subgroup analysis by age, duration of diabetes and baseline glycated haemoglobin concentration.
Diabetes, obesity & metabolism · 2018 · Open access · Likely link

Summary

The main purpose of this study is to evaluate the use of the study drug known as dulaglutide in participants with type II diabetes who are taking once-daily insulin glargine. The study will last about 31 weeks for each participant.

Linked Publications (2)

  • Dulaglutide 1.5 mg as an add-on option for patients uncontrolled on insulin: Subgroup analysis by age, duration of diabetes and baseline glycated haemoglobin concentration.
    Diabetes, obesity & metabolism · 2018 · 20 citations · Open access · Likely link
  • Patient-reported Outcomes in Patients with Type 2 Diabetes Treated with Dulaglutide Added to Titrated Insulin Glargine (AWARD-9).
    Clinical therapeutics · 2017 · 19 citations · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c)
-1.44; -0.67 <.001 sig
SECONDARY
Change From Baseline to 28 Weeks in Fasting Serum Glucose (FSG)
-44.63; -27.90 <.001 sig
SECONDARY
Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)
-44.03; -35.97; -64.16; -46.97; -40.89; -25.34 .007 sig
SECONDARY
Change From Baseline to 28 Weeks in Body Weight
-1.91; 0.50 <.001 sig
SECONDARY
Change From Baseline to 28 Weeks in Daily Mean Insulin Glargine Dose
12.75; 25.94 <.001 sig
SECONDARY
Number of Participants With Investigator Reported and Adjudicated Cardiovascular Events
3; 1
SECONDARY
Percentage of Participants With Self-Reported Events of Hypoglycemia
35.3; 30.0; 42.7; 39.3; 0.7; 0.0
SECONDARY
Percentage of Participants Discontinuing the Study Due to Severe, Persistent Hyperglycemia
0; 0
SECONDARY
Number of Participants With Adjudicated Acute Pancreatitis Events
0; 0
SECONDARY
Number of Participants With Thyroid Tumors/Neoplasms (Including C-Cell Hyperplasia)
1; 0
SECONDARY
Number of Participants With Dulaglutide Anti-Drug Antibodies
0; 2
SECONDARY
Percentage of Participants Achieving HbA1c Targets of <7.0% or ≤6.5%
50.7; 16.7; 69.3; 35.3 <.001 sig
SECONDARY
Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 Kilograms [kg]) at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)
40.7; 16.7 <.001 sig
SECONDARY
Percentage of Participants Achieving HbA1c Target of <7.0% at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)
52.0; 28.0 <.001 sig
SECONDARY
Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 kg)
52.7; 20.0 <.001 sig
SECONDARY
Rate of Hypoglycemic Events up to 28 Weeks
0.63; 0.70

Eligibility Criteria

Inclusion Criteria

  • Have type 2 diabetes (based on the World Health Organization's [WHO] diagnostic criteria)
  • Have been treated with basal insulin glargine once daily with or without metformin for at least 3 months prior to screening
  • Doses of once daily insulin glargine and metformin (if taken) must be stable during the 3-month period prior to screening. Doses of metformin are considered stable if all prescribed doses during this period are in the range between the minimum required dose (≥1500 mg/day) and the maximum approved dose per the locally-approved label
  • Have an HbA1c value ≥7.0% and ≤10.5% as assessed by the central laboratory at screening
  • Require further insulin glargine dose increase at week 3 per the treat-to-target (TTT) algorithm based on the SMPG data collected during the prior week
  • Have stable weight (±5%) ≥3 months prior to screening
  • Have body mass index (BMI) ≤45 kilograms per square meter (kg/m^2) at screening
  • Are able and willing to administer once weekly randomized therapy
  • Are females of childbearing potential who must:
  • Test negative for pregnancy at screening, based on a serum pregnancy test
  • Agree to use a reliable method of birth control
  • Not be breastfeeding

Exclusion Criteria

  • Have been treated with ANY other antihyperglycemia regimen, other than basal insulin glargine once daily with or without metformin, within the 3 months prior to screening or between screening and week 3
  • Have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma
  • Have a history of hypoglycemia unawareness within the 6 months prior to screening
  • Have been treated with drugs that promote weight loss within the 3 months prior to screening or between screening and week 3
  • Are receiving chronic (>14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks prior to screening or between screening and week 3
  • Have had any of the following cardiovascular conditions within the 2 months prior to screening: acute myocardial infarction (MI), New York Heart Association (NYHA) Class III or Class IV heart failure, or cerebrovascular accident (stroke)
  • Have a known clinically significant gastric emptying abnormality or have undergone gastric bypass surgery or restrictive bariatric surgery
  • Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine aminotransferase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory
  • Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis within the 3 months prior to screening
  • Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 square meter (mL/min/m^2), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory; for participants on metformin, have renal disease or renal dysfunction (for example, a serum creatinine ≥1.5 mg/deciliter [dL] [male] or ≥1.4 mg/dL [female] or eGFR [CKD-EPI] <60 mL/min/1.73 m^2)
  • Have evidence of a significant, uncontrolled endocrine abnormality
  • 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
  • Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)
  • Have serum calcitonin ≥20 picograms/mL, as determined by the central laboratory
  • Have evidence of a significant, active autoimmune abnormality
  • Have any other condition not listed in this section that is a contraindication for use of insulin glargine, or, for participants using metformin, have a condition that is a contraindication for the use of metformin and would require metformin discontinuation per label
  • Have a history of transplanted organ
  • Have a history of active or untreated malignancy, or are in remission from a cli
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02152371) 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.

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