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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01075282
First received: February 23, 2010
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HBA1c)and safe, as compared to Insulin Glargine in patients with Type 2 Diabetes. Patients must also be taking metformin and glimepiride.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin Glargine
Drug: LY2189265
Drug: Metformin
Drug: Glimepiride
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: A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Glimepiride

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline to 52 weeks endpoint in glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to 26 weeks and 78 weeks endpoint in glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline, 26 weeks and 78 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26, 52 and 78 weeks for body weight [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26, 52 and 78 weeks for blood glucose values from the 8-point self-monitored blood glucose (SMGB), profiles [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26, 52 and 78 weeks in the EuroQol 5 Dimension [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26, 52 and 78 weeks in the Impact of Weight on Activities of Daily Living [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26, 52 and 78 weeks in the Impact of Weight on Self-Perception [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26, 52 and 78 weeks in the Low Blood Sugar Survey [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26, 52 and 78 weeks on electrocardiogram parameters [ Time Frame: 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
  • Number of reported and adjudicated cardiovascular events at 26, 52 and 78 weeks [ Time Frame: 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
  • Change in baseline to 26, 52 and 78 weeks on pulse rate [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26, 52 and 78 weeks on blood pressure [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
  • Number of events of pancreatitis at 26, 52 and 78 weeks [ Time Frame: 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26, 52 and 78 weeks on pancreatic enzymes [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26, 52 and 78 weeks on serum calcitonin [ Time Frame: Baseline, 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
  • Number of self-reported hypoglycemic events at 26, 52 and 78 weeks [ Time Frame: 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of patients requiring additional intervention due to hyperglycemia at 26, 52 and 78 weeks [ Time Frame: 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of LY2189265 antibodies at 26, 52, 78 weeks and 4 weeks after last dose of study drug, so 83 weeks at the maximum [ Time Frame: Baseline, 26, 52, 78 and 83 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of treatment emergent adverse events at 26, 52 and 78 weeks [ Time Frame: 26, 52 and 78 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients achieving HbA1c less than 7% at 26, 52 and 78 weeks [ Time Frame: 26, 52 and 78 weeks ] [ Designated as safety issue: No ]
  • Number of patients achieving HbA1c less than or equal to 6.5% at 26, 52 and 78 weeks [ Time Frame: 26, 52 and 78 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 and 78 weeks in glucagon concentration [ Time Frame: Baseline, 52 and 78 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 and 78 weeks in HOMA2-%S and HOMA2%B [ Time Frame: Baseline, 52 and 78 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 837
Study Start Date: February 2010
Study Completion Date: November 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.75 mg LY2189265 Drug: LY2189265
Administered as subcutaneous injection, once weekly for 78 weeks
Other Name: Dulaglutide
Drug: Metformin
Administered orally at least 1500 milligram per day (mg/day)
Drug: Glimepiride
Administered orally at least 4 mg/day
Experimental: 1.5 mg LY2189265 Drug: LY2189265
Administered as subcutaneous injection, once weekly for 78 weeks
Other Name: Dulaglutide
Drug: Metformin
Administered orally at least 1500 milligram per day (mg/day)
Drug: Glimepiride
Administered orally at least 4 mg/day
Active Comparator: Insulin Glargine Drug: Insulin Glargine
Administered as subcutaneous injection with dose titration based on blood glucose measures once daily for 78 weeks
Drug: Metformin
Administered orally at least 1500 milligram per day (mg/day)
Drug: Glimepiride
Administered orally at least 4 mg/day

  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 (at least one of them must be metformin and/or sulfonylurea)

    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 1500 mg metformin a day and glimepiride 4 mg per day.
  • Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for insulin glargine.
  • 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 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 Heart Failure New York Heart Classification 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 3.0 of upper normal limit
  • 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 creatinine 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: NCT01075282

  Show 78 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: NCT01075282     History of Changes
Other Study ID Numbers: 11374, H9X-MC-GBDB
Study First Received: February 23, 2010
Last Updated: January 22, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: Ministry of Health
Canada: Health Canada
United States: Food and Drug Administration
India: Ministry of Health
Mexico: Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Glargine
Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014