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
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: 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 July 22, 2014