A Study of Dulaglutide (LY2189265) in Participants With Type II Diabetes (AWARD-9)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02152371
First received: May 28, 2014
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Dulaglutide
Drug: Placebo
Drug: Insulin Glargine
Drug: Metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Trial Comparing the Effect of Dulaglutide 1.5 mg With Placebo on Glycemic Control in Patients With Type 2 Diabetes on Basal Insulin Glargine

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline to 28 Weeks in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 28 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline to 28 Weeks in Fasting Serum Glucose [ Time Frame: Baseline, 28 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG) [ Time Frame: Baseline, 28 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to 28 Weeks in Body Weight [ Time Frame: Baseline, 28 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to 28 Weeks in Daily Mean Insulin Glargine Dose [ Time Frame: Baseline, 28 Weeks ] [ Designated as safety issue: No ]
  • Number of Participants with Reported and Adjudicated Cardiovascular Events [ Time Frame: Baseline through 28 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants with Self-Reported Events of Hypoglycemia [ Time Frame: Baseline through 28 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants Discontinuing the Study Due to Severe, Persistent Hyperglycemia [ Time Frame: Baseline through 28 Weeks ] [ Designated as safety issue: No ]
  • Number of Participants with Adjudicated Acute Pancreatitis Events [ Time Frame: Baseline through 28 Weeks ] [ Designated as safety issue: No ]
  • Number of Participants with Thyroid Neoplasms [ Time Frame: Baseline through 28 Weeks ] [ Designated as safety issue: No ]
  • Number of Participants with Dulaglutide Anti-Drug Antibodies [ Time Frame: Baseline up to 4 Weeks Post Last Dose of Study Drug ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving HbA1c Targets of <7.0% or ≤6.5% [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving HbA1c Target of <7.0% at 28 Weeks and Without Documented Symptomatic Hypoglycemia during the Maintenance Period (Weeks 12-28) [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 kg) [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]
  • Rate of Self-Reported Hypoglycemic Events up to 28 Weeks [ Time Frame: Baseline through 28 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 308
Study Start Date: May 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dulaglutide + Insulin Glargine
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Drug: Dulaglutide
Administered SQ
Other Name: LY2189265
Drug: Insulin Glargine
Administered SQ
Drug: Metformin
Administered orally
Placebo Comparator: Placebo + Insulin Glargine
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Drug: Placebo
Administered SQ
Drug: Insulin Glargine
Administered SQ
Drug: Metformin
Administered orally

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 clinically significant malignancy during the 5 years prior to screening
  • Have a history of any other condition which, in the opinion of the investigator, may preclude the participants from following and completing the protocol
  • Have any hematologic condition that may interfere with HbA1c measurement (eg, hemolytic anemias, sickle-cell disease)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02152371

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 39 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02152371     History of Changes
Other Study ID Numbers: 13195, H9X-MC-GBDI, 2012-004229-25
Study First Received: May 28, 2014
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Italy: The Italian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Metformin
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014