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A Study in Patients With Type 2 Diabetes Mellitus (AWARD-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01064687
First received: February 5, 2010
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to determine if LY2189265 is effective and safe in reducing hemoglobin A1c (HBA1c), as compared to placebo (no medicine), or exenatide in patients with Type 2 Diabetes. The patient's must also be taking metformin and pioglitazone.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Exenatide
Drug: LY2189265
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Comparison of the Effects of Two Doses of LY2189265 or Exenatide on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Pioglitazone (AWARD-1: Assessment of Weekly Administration of LY2189265 in Diabetes-1)

Resource links provided by NLM:

Drug Information available for: Exenatide
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 body weight [ Time Frame: Baseline, 26 weeks, 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 (SMGB), profiles [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of patients attaining HbA1c less than 7% and less than or equal to 6.5 % at 26 weeks and 52 weeks [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 and 52 weeks in patients using the updated the Homeostasis Model Assessment of beta-cell function [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 and 52 weeks in the EuroQol 5 [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks in the Diabetes Treatment Satisfaction Questionnaire Status and Change versions [ 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 [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks on body mass index [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26 and 52 weeks on the Impact of Weight on Self-Perception [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Number of reported and adjudicated cardiovascular events at 26 and 52 weeks [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 and 52 weeks on electrocardiogram parameters [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change in baseline to 26 weeks and 52 weeks on pulse rate [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 and 52 weeks on blood pressure [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Number of events of pancreatitis at 26 and 52 weeks [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 and 52 weeks on pancreatic enzymes [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 and 52 weeks on serum calcitonin [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Number of self-reported hypoglycemic events at 26 and 52 weeks [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of patients receiving rescue therapy due to hyperglycemia at 26 and 52 weeks [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Time to intervention in patients requiring rescue therapy due to hyperglycemia [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Presence of LY2189265 antibodies at 26 and 52 weeks and 4 weeks after last dose of study drug [ Time Frame: 26 weeks, 52 weeks, 4 weeks after last dose ] [ Designated as safety issue: Yes ]
  • Number of treatment emergent adverse events at 26 and 52 weeks [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 and 52 weeks in hematological and biochemical lab values [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 weeks on N Terminal pro Brain Natriuretic Peptide [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: Yes ]
  • Measurement of LY2189265 drug concentration for pharmacokinetics [ Time Frame: Week 4, Week 13, Week 26, Week 52 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 980
Study Start Date: February 2010
Study Completion Date: May 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exenatide Drug: Exenatide
5 mcg administered by subcutaneous injection two times a day for 4 weeks; followed thereafter by 10 mcg administered by subcutaneous injection two times a day for 48 weeks
Placebo Comparator: Placebo
After 26 weeks, placebo arm subjects will be randomized to either 0.75mg or 1.5mg LY2189265 administered by subcutaneous injection once weekly for 26 weeks.
 Drug: LY2189265
Administer by subcutaneous injection once weekly
Other Name: dulaglutide
Drug: Placebo
Administer by subcutaneous injection once weekly
Experimental: 1.5mg LY2189265
For 52 weeks
 Drug: LY2189265
Administer by subcutaneous injection once weekly
Other Name: dulaglutide
Experimental: 0.75 mg LY2189265
For 52 weeks
 Drug: LY2189265
Administer by subcutaneous injection once weekly
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 not well controlled on 1,2,or 3 oral diabetic medications

    1. HbA1c greater than or equal to 7 and less than or equal to 11 if taking 1 oral diabetic medication
    2. HbA1c greater than or equal to 7 and less than 10 if on 2 or 3 oral diabetic medications
  • Able to tolerate minimum dose of 1500mg metformin a day and pioglitazone 30 mg per day.
  • Willing to inject subcutaneous medication up to 2 times per day
  • Stable weight for 3 months prior to screening
  • BMI (body mass index) between 23 and 45 kg/m2
  • Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test 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
  • HbA1c equal to or less than 6.5 before randomization or at randomization
  • Chronic Insulin use
  • Taking drugs to promote weight loss by prescription or over the counter
  • Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled
  • History of fluid retention or edema
  • History of Heart Failure New York Heart Classification II,III, or IV or acute myocardial infarction or stroke within 2 months of screening
  • GI (stomach) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility
  • Hepatitis or liver disease or ALT (alanine transaminase) greater than 2.5 of normal
  • Acute or chronic pancreatitis of any form
  • Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 mg/dL for males and greater than or equal to 1.4 mg/dL for females, or a creatine clearance of less than 60 ml/min
  • History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer
  • A serum calcitonin greater than or equal to 20 pcg/ml at screening
  • Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
  • History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years
  • Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing
  • Organ transplant except cornea
  • Have enrolled in another clinical trial within the last 30 days
  • Have previously signed an informed consent or participated in a LY2189265 study
  • Have taken a GLP-1 receptor agonist within the 3 months prior to screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064687

  Show 89 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: NCT01064687     History of Changes
Other Study ID Numbers: 11373, H9X-MC-GBDA
Study First Received: February 5, 2010
Last Updated: June 14, 2012
Health Authority: United States: Food and Drug Administration
Mexico: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Argentina: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013