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A Study in Patients With Type 2 Diabetes Mellitus (AWARD-4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01191268
First received: August 27, 2010
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to determine if LY2189265 in combination with insulin lispro is effective and safe in reducing hemoglobin A1c, as compared to insulin glargine in combination with insulin lispro in patients with Type 2 Diabetes.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Insulin Glargine
Drug: LY2189265
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of LY2189265 Versus Insulin Glargine in Combination With Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus (AWARD-4: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 4)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline to 26 weeks endpoint in glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to 52 weeks endpoint in glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks for blood glucose values from the 8-point self-monitored blood glucose(SMBG) profiles [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients attaining HbA1c less than 7% and less than or equal to 6.5% at weeks 26 and 52 [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26, 52 weeks, and 4 weeks after last dose for body weight [ Time Frame: Baseline, 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 and 52 weeks in total daily insulin lispro dose [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks in the EuroQoL5 [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks in the Impact of Weight on Self-Perception (IW-SP) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks in the Low Blood Sugar Survey (LBSS) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks, and 4 weeks after last dose on blood pressure [ Time Frame: Baseline, 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Number of events of pancreatitis at 26 and 52 weeks, and 4 weeks after last dose [ Time Frame: 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 and 52 weeks, and 4 weeks after last dose on pancreatic enzymes [ Time Frame: Baseline, 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 weeks and 52 weeks, and 4 weeks after last dose on serum calcitonin [ Time Frame: Baseline, 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Number of self-reported hypoglycemic events at 26 weeks and 52 weeks, and 4 weeks after last dose [ Time Frame: 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Presence of LY2189265 antibodies at 26 weeks and 52 weeks and 4 weeks after last dose [ Time Frame: 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 , 52, and 4 weeks after last dose in Body Mass Index (BMI) [ Time Frame: Baseline, 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 weeks and 52 weeks in fasting blood glucose [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks in the percentage of patients achieving HbA1c <7% without nocturnal hypoglycemia [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 837
Study Start Date: November 2010
Study Completion Date: September 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insulin Glargine Drug: Insulin Glargine
Administered by subcutaneous injection once at bedtime dose dependent on treat to target algorithm for 52 weeks
Experimental: 1.5 mg LY2189265 Drug: LY2189265
Administered once weekly by subcutaneous injection for 52 weeks
Other Name: Dulaglutide
Experimental: 0.75 mg LY2189265 Drug: LY2189265
Administered once weekly by subcutaneous injection for 52 weeks
Other Name: Dulaglutide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Currently using insulin for at least 3 months with a conventional insulin regimen with or without oral medications
  • HbA1c greater than or equal to 7% and less than or equal to 11%
  • Willing to inject subcutaneous medication
  • Willing to monitor blood glucose levels and adjust insulin dose
  • Willing to maintain a study diary
  • Body mass index (BMI) between 23 and 45 kg/m2
  • Stable weight for 3 months prior to screening
  • Females of child bearing potential must test negative for pregnancy at screening and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug

Exclusion Criteria:

  • Type 1 Diabetes
  • Previous therapy with GLP 1 agonists within 3 months prior to screening
  • 1 or more episodes of ketoacidosis within 6 months prior to screening
  • Have been treated with prescription or over the counter medication to promote weight loss within 3 months prior to screening
  • Estimated glomerular filtration rate (eGFR) less than or equal to 30 mL/min/1.73 m2 at screening
  • Taking steroids for greater than 14 days except for topical, eye, nasal, or inhaled
  • History of heart failure, New York Heart Classification III, IV within 2 months prior to screening
  • GI (stomach) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking medications that directly affect GI motility
  • Acute or chronic hepatitis or pancreatitis
  • Self or family history of 2A or type 2B multiple endocrine neoplasia or medullary C-Cell hyperplasia
  • Serum calcitonin greater than or equal to 20 pcg/ml at screening
  • Organ transplant except cornea
  • Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
  • History of or active malignancy except skin or in situ cervical or prostate cancer within the last 5 years
  • Known drug or alcohol abuse
  • Have enrolled in another clinical trial within the last 30 days
  • Have previously signed an informed consent or participated in a LY2189265 study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191268

  Show 101 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: NCT01191268     History of Changes
Other Study ID Numbers: 11376, H9X-MC-GBDD
Study First Received: August 27, 2010
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Australia: National Health and Medical Research Council
Belgium: Ministry of Social Affairs, Public Health and the Environment
Brazil: Ministry of Health
Canada: Health Canada
Denmark: Danish Medicines Agency
Greece: Ministry of Health and Welfare
Hungary: Institutional Ethics Committee
Mexico: Ministry of Health
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
South Africa: Human Research Ethics Committee
Spain: Ministry of Health
Taiwan: Center for Drug Evaluation

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

ClinicalTrials.gov processed this record on May 23, 2013