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

February 23, 2010
January 22, 2013
February 2010
May 2012   (final data collection date for primary outcome measure)
Change from baseline to 52 weeks endpoint in glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01075282 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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: No ]
  • 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 ]
Not Provided
Not Provided
 
A Study in Patients With Type 2 Diabetes Mellitus (AWARD-2)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Insulin Glargine
    Administered as subcutaneous injection with dose titration based on blood glucose measures once daily for 78 weeks
  • 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: 0.75 mg LY2189265
    Interventions:
    • Drug: LY2189265
    • Drug: Metformin
    • Drug: Glimepiride
  • Experimental: 1.5 mg LY2189265
    Interventions:
    • Drug: LY2189265
    • Drug: Metformin
    • Drug: Glimepiride
  • Active Comparator: Insulin Glargine
    Interventions:
    • Drug: Insulin Glargine
    • Drug: Metformin
    • Drug: Glimepiride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
837
November 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Croatia,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Taiwan,   Czech Republic,   France,   Greece,   Hungary,   India,   Italy,   Korea, Republic of,   Mexico,   Poland,   Romania,   Slovakia,   Spain,   Sweden
 
NCT01075282
11374, H9X-MC-GBDB
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP